China Stroke Primary Prevention Trial 2 for Participants with Hypertension and MTHFR 677 TT Genotype (CSPPT2-TT)

February 24, 2025 updated by: Shenzhen Ausa Pharmed Co.,Ltd

Comparative Efficacy of Amlodipine Folic Acid Vs. Amlodipine on the Risk of First Ischemic Stroke Among Participants with Hypertension and MTHFR 677 TT Genotype: a Multi-center, Randomized, Double-blind, Triple-dummy, Controlled Clinical Trial

This is a multi-center, randomized, double-blind, triple-dummy, controlled trial in 24,000 Chinese men and women with hypertension and MTHFR 677 TT genotype.

The study participants will be randomized to one of the three treatment groups:

Group A: amlodipine tablet (5mg), taken orally, once daily, serving as active comparator.

Group B: amlodipine folic acid 5.8mg tablet (5mg amlodipine and 0.8mg folic acid), taken orally, once daily.

Group C: amlodipine folic acid 5.8mg tablet plus 5-methyltetrahydrofolate (5-MTHF, 0.4mg), taken orally, once daily.

The primary endpoint is first ischemic stroke.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study consists of 3 periods: Screening, Run-in, and Randomized treatment.

Period I: Screening (V0)

The purpose of Period I is to obtain informed consent and screen for eligible participants.

After obtaining written informed consent, at the screening visit (V0), participants will complete a face-to-face interview and clinical evaluation and measurements. Their biological samples will be collected for laboratory analyses. Collectively, these information will help to determine eligibility for inclusion in the study.

Period II: Run-in Period (VD)

The purpose of Run-in is to assess participants' compliance for following the amlodipine treatment regimen as well as to observe participants' tolerance to amlodipine, so as to screen out those with poor compliance or intolerance to amlodipine treatment.

The run-in phase lasted 2 to 4 weeks, during which oral administration of Amlodipine tablets (5 mg) was given once daily.

Period III: Randomized Treatment (V1-V21)

This is a 5-year period of randomized, double-blind, triple-dummy, controlled treatment. At each of the research centers, participants who remain eligible for participation in the study will be randomized into 3 treatment groups:

A. Amlodipine-only (5mg/d) with an amlodipine folic acid placebo and 5-MTHF placebos.

B. Amlodipine folic acid tablet (5.8mg/d) with amlodipine placebo and 5-MTHF placebo.

C. Amlodipine folic acid tablets (5.8mg/d) and 5-MTHF (0.4mg/d) with an amlodipine placebo in a 1:1:1 ratio, using the randomization and trial supply management (RTSM) platform.

During the treatment period, other antihypertensive drugs can be added to achieve blood pressure control (BP ≤140/90mmHg), including Valsartan (80mg/d), or/and Indapamide (1.5mg/d), or/and metoprolol tartrate tablets (25mg/d). Participants will be followed up every 3 months during the treatment period, and the treatment drugs will be distributed at each visit.

A total of 24,000 participants will be randomly assigned to one of three treatment groups (Group A n=8,000, Group B n=8,000, Group C n=8,000). Based on published data from CSPPT (Huo et al, JAMA, 2015), the 5-year cumulative incidence of first ischemic stroke in the amlodipine-only group is 3.5%. Assuming the 5-year cumulative incidence of first ischemic stroke in the amlodipine-only group is around 3.5%, this trial has 80% power to detect a 20% difference between group A and group B+C in the observed hazard ratio (HR) for incident ischemic stroke (HR≤0.80), at a two-sided significance level of α=0.05. If instead, the 5-year incidence of ischemic stroke in the amlodipine-only group is 2.5%, this trial has 80% power to detect a 23% difference between the treatment groups (A vs B+C) (HR≤0.77).

There are two planned interim analyses, one at the end of the third year, and another at the end of the fourth year. The O'Brien-Fleming alpha-spending function will be used to define the significance level of each interim analysis to ensure that the final overall two-sided significance level of α=0.05 is met.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • Not yet recruiting
        • First Affillated Hospital of Bengbu Medical University
        • Contact:
        • Contact:
          • Hongju Wang, MD
      • Bozhou, Anhui, China
        • Not yet recruiting
        • Bozhou People's Hospital
        • Contact:
          • Rongyan Jiang
        • Contact:
          • Rongyan Jiang, MD
      • Chizhou, Anhui, China
        • Not yet recruiting
        • Chizhou People's Hospital
        • Contact:
          • Xiaodong Xu, MD
      • Fuyang, Anhui, China
        • Not yet recruiting
        • Taihe County People's Hospital
        • Contact:
          • Shuguang Zhao, MD
        • Contact:
          • Yongjun Zhai, MD
    • Beijing
      • Beijing, Beijing, China
        • Not yet recruiting
        • Peking University First Hospital
        • Contact:
          • Jianping Li, MD, PhD
    • Guangdong
      • Yangjiang, Guangdong, China
        • Not yet recruiting
        • Yangjiang People's Hospital
        • Contact:
          • Qianqian Tan, MD
    • Guizhou
      • Guiyang, Guizhou, China
        • Not yet recruiting
        • The Affiliated Hospital of Guizhou Medical University
        • Contact:
          • Wei Li, MD
        • Contact:
          • Fang Wei
    • Hunan
      • Huaihua, Hunan, China
        • Not yet recruiting
        • The First Affiliated Hospital of Hunan University of Medicine
        • Contact:
          • Bifeng Tan
        • Contact:
          • Bifeng Tan, MD
      • Loudi, Hunan, China
        • Not yet recruiting
        • Loudi Central Hospital
        • Contact:
          • Weimin Hu, MD
    • Jiangsu
      • Lianyungang, Jiangsu, China
        • Not yet recruiting
        • The Second People's Hospital of Lianyungang
        • Contact:
          • Liming Sun, MD
      • Lianyungang, Jiangsu, China, 222042
        • Recruiting
        • Lianyungang Oriental Hospital
        • Contact:
        • Contact:
          • Yubao Wang, MD
      • Lianyungang, Jiangsu, China
        • Not yet recruiting
        • The First People's Hospital of Lianyungang
        • Contact:
          • Hui Shi, MD
      • Yancheng, Jiangsu, China
        • Not yet recruiting
        • Yancheng First People's Hospital
        • Contact:
          • Qilong Zuo, MD
    • Jiangxi
      • Ganzhou, Jiangxi, China
        • Not yet recruiting
        • The First Affiliated Hospital of Gannan Medical University
        • Contact:
          • Guoxi Zhang, MD
        • Contact:
          • Yanwei Lai, MD
      • Nanchang, Jiangxi, China
        • Not yet recruiting
        • Second Affiliated Hospital of Nanchang University
        • Contact:
          • Huihui Bao, MD
    • Shaanxi
      • Weinan, Shaanxi, China
        • Not yet recruiting
        • Weinan Central Hospital
        • Contact:
          • Junnong Li, MD
    • Shandong
      • Zaozhuang, Shandong, China, 277599
        • Not yet recruiting
        • Tengzhou Central People's Hospital
        • Contact:
        • Contact:
          • Yong Li, MD
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • Chengdu Fifth People's Hospital
        • Contact:
          • Lihua Zhou, MD
      • Deyang, Sichuan, China
        • Not yet recruiting
        • Deyang People's Hospital
        • Contact:
          • Yangyun Han, MD
      • Luzhou, Sichuan, China
        • Not yet recruiting
        • The affiliated hospital of Southwest Medical University
        • Contact:
          • Juyi Wan
        • Contact:
          • Juyi Wan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men and women, aged ≥45 and <75 years.
  2. Hypertension: Previously diagnosed with primary hypertension and has been taking antihypertensive medication within the past two weeks; OR has not been taking antihypertensive medications within the last two weeks, but meets the following criteria for hypertension: SBP≥140 mmHg and/or DBP≥90 mmHg (average of at least 2 measurements each time) at two separate (not on the same day) clinical visits.
  3. MTHFR 677 TT genotype (based on the test results from the central laboratory during the screening period or a previous official test report from a laboratory with medical testing qualifications).
  4. Voluntarily participates and has given signed informed consent.

Randomized-treatment phase inclusion criteria:

  1. Good compliance during the run-in period, and unlikely to discontinue treatment;
  2. No stroke or cardiovascular events during the run-in period;
  3. The participant voluntarily agrees to continue the study.

Exclusion Criteria:

  1. Previously diagnosed secondary hypertension;
  2. Previously diagnosed stroke;
  3. Previously diagnosed myocardial infarction;
  4. Previously diagnosed heart failure;
  5. Previously diagnosed atrial fibrillation;
  6. Cardio-cerebral-kidney revascularization and/or other large arterial stent;
  7. Currently on dialysis, or diagnosed with stage 4-5 chronic kidney disease, or eGFR <30 mL/ min/1.73m²;
  8. Known to have congenital (such as aortic stenosis) or acquired organic heart disease;

  9. Known to have any of the following severe diseases or conditions:

    1. Digestive system: i. Previously diagnosed with any form of viral hepatitis that is currently still in the active phase; ii. Abnormal liver function test before enrollment (any of ALT, AST, GGT, TBIL, DBIL test 3 times higher than normal, or ALB≤30g/L); iii. Subtotal gastrectomy and/or gastrojejunostomy;
    2. Respiratory system: previously diagnosed with pulmonary heart disease;
    3. Presence of malignant tumors or other severe diseases;
    4. Presence of long-term gastrointestinal symptoms such as ; anorexia, decreased appetite, nausea, and abdominal bloating;
    5. Previously diagnosed with vitamin B12 deficiency and/or its related diseases.
  10. Participant, at the investigator's discretion, is assessed to be unsuitable for the study, for reasons including but not limited to the presence of abnormal laboratory results, or clinical conditions;
  11. Prior history of significant intolerance due to adverse reactions resulting from usage of amlodipine or other CCBs, valsartan or other ARBs, indapamide or other similar diuretics, metoprolol tartaric acid or other beta-blockers, or any drugs or health products containing folate or folic acid;
  12. Regular consumption of folic acid or vitamin B compounds, or other compounds containing folic acid in the past 3 months;

  13. The presence of any of the following conditions that could negatively influence a participant's ability to consent or participate in the trial:

    1. Dementia;
    2. Severe mental disorders;
    3. Inability to express informed consent;
    4. Unlikely to complete the study follow-up as specified by the protocol, or plans to relocate outside of the study area in the near future;
    5. History of poor compliance when taking antihypertensive medications or is expected to have poor compliance during the study;
  14. Refusal to participate, or inability to modify current drug regimen;
  15. Women who are pregnant or breastfeeding; or subjects of childbearing potential who are unwilling or unable to use effective contraception during the study period.
  16. Within one month prior to the first visit, having participated in any clinical trial for a drug that has not yet been officially approved by the state or is not currently approved for sale; or currently participating in any clinical trial that could potentially impact the results of this study (medication use, drug efficacy, drug interaction, etc.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Amlodipine (5mg/d)

Amlodipine 5mg x1 tablet + Amlodipine folic acid (dummy) x1 tablet + 5-MTHF (dummy) x2 tablets, taken orally, in the morning after waking up.

Amlodipine tablets, amlodipine folic acid placebos, and 5-MTHF placebos are provided in aluminum-plastic blister plate. Each package includes 100 days of treatment drug (including 10 extra days of treatment for the follow-up window). A package of medication consists of 50 plates, each plate includes a total of 8 tablets arranged as follows: amlodipine 5mg x2 tablets + amlodipine folic acid (dummy) x2 tablets + 5-MTHF (dummy) x4 tablets. Affixed to the package is the randomized treatment drug label (400 tablets/package, 4 tablets/day).
Drug: Amlodipine besylate
The amlodipine used in this study is a listed product.
Other Names:
  • Amlodipine
Drug: Amlodipine folic acid placebo
Amlodipine folic acid placebos are dummy pills of amlodipine folic acid with identical appearance.
Other Names:
  • Amlodipine folic acid (dummy)
Drug: 5-MTHF Placebos
5-MTHF placebos are the dummy pills of 5-MTHF with identical appearance.
Other Names:
  • 5-MTHF (dummy)
Experimental: Amlodipine folic acid (5.8mg/d)

Amlodipine folic acid 5.8mg x1 tablet + amlodipine (dummy) x1 tablet + 5-MTHF (dummy) x2 tablets, taken orally, in the morning after waking up.

Amlodipine folic acid tablets, amlodipine placebos, and 5-MTHF placebos are provided in aluminum-plastic blister plate. Each package includes 100 days of treatment drug (including 10 extra days of treatment for the follow-up window). A package of medication consists of 50 plates, each plate includes a total of 8 tablets arranged as follows: amlodipine folic acid 5.8mg x2 tablets + amlodipine (dummy) x2 tablets + 5-MTHF (dummy) x4 tablets. Affixed to the package is the randomized treatment drug label (400 tablets/package, 4 tablets/day).
Drug: 5-MTHF Placebos
5-MTHF placebos are the dummy pills of 5-MTHF with identical appearance.
Other Names:
  • 5-MTHF (dummy)
Drug: Amlodipine besylate And Folic Acid
The amlodipine besylate and folic acid tablets have been approved for listing by the China Food and Drug Administration, approval number: Zhunzi H20180020.
Other Names:
  • Anye
  • Amlodipine Folic Acid
Drug: Amlodipine placebo
Amlodipine placebos are dummy pills of amlodipine with identical appearance.
Other Names:
  • Amlodipine (dummy)
Experimental: Amlodipine folic acid (5.8mg/d) + 5-MTHF (0.4mg/d)

Amlodipine folic acid 5.8mg x1 tablet + 5-methyltetrahydrofolate 0.2mg x2 tablets + amlodipine (dummy) x1 tablet, taken orally, in the morning after waking up.

Amlodipine folic acid tablets, 5-MTHF, and amlodipine placebos are provided in aluminum-plastic blister plate. Each package includes 100 days of treatment drug (including 10 extra days of treatment for the follow-up window). A package of medication consists of 50 plates, each plate includes a total of 8 tablets arranged as follows: amlodipine folic acid 5.8mg x2 tablets + amlodipine (dummy) x2 tablets + 5-MTHF, 0.2mg x4 tablets. Affixed to the package is the randomized treatment drug label (400 tablets/package, 4 tablets/day).
Drug: Amlodipine besylate And Folic Acid
The amlodipine besylate and folic acid tablets have been approved for listing by the China Food and Drug Administration, approval number: Zhunzi H20180020.
Other Names:
  • Anye
  • Amlodipine Folic Acid
Drug: Amlodipine placebo
Amlodipine placebos are dummy pills of amlodipine with identical appearance.
Other Names:
  • Amlodipine (dummy)
Drug: 5-methyltetrahydrofolate (5-MTHF)
The 5-MTHF used in this study is a listed product.
Other Names:
  • 5-MTHF

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
First ischemic stroke
Time Frame: By the end of the fifth year of the study
The primary aim of the trial is to determine whether amlodipine folic acid tablets (including Group B and Group C), compared to amlodipine alone (Group A), can further reduce the risk of first ischemic stroke among eligible participants with hypertension and the MTHFR 677 TT genotype.
By the end of the fifth year of the study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
First ischemic stroke (for refined treatment group comparisons)
Time Frame: By the end of the fifth year of the study

We will examine whether there exist significant differences in efficacy in reducing the risk of first ischemic stroke between the following pairs of treatment groups:

Group B vs. Group A

Group C vs. Group A

Group B vs. Group C
By the end of the fifth year of the study
First stroke (ischemic and hemorrhagic)
Time Frame: By the end of the fifth year from baseline

We will examine whether there exist significant differences in efficacy in reducing the risk of first stroke between the following pairs of treatment groups:

Groups B + C vs. Group A

Group B vs. Group A

Group C vs. Group A

Group B vs. Group C
By the end of the fifth year from baseline
Composite cardiovascular endpoint (first non-fatal stroke, first non-fatal myocardial infarction, cardiovascular death)
Time Frame: By the end of the fifth year from baseline

We will examine whether there exist significant differences in efficacy in reducing the risk of composite cardiovascular endpoint between the following pairs of treatment groups:

Groups B + C vs. Group A

Group B vs. Group A

Group C vs. Group A

Group B vs. Group C
By the end of the fifth year from baseline
Kidney outcomes
Time Frame: By the end of the fifth year from baseline
  1. The primary kidney outcome is composite kidney outcome, defined as: (1) a decrease in eGFR of 30% or more and to a level of less than 60 mL/min/1.73 m2 if the baseline eGFR is 60 mL/min/1.73 m2 or more, or (2) a decrease in eGFR of 50% or more if the baseline eGFR is less than 60 mL/min/1.73 m2, or (3) end-stage kidney disease (ESKD) (eGFR <15 mL/min/1.73m2 or dialysis or kidney transplantation).
  2. Secondary kidney outcomes: (1) eGFR decline ≥40% from baseline, or end-stage kidney disease; (2) annual rate of relative decline in eGFR; (3) Incidence of proteinuria, or progression of proteinuria.

We will examine whether there exist significant differences in treatment efficacy on the above kidney endpoints between the following pairs of treatment groups:

Groups B + C vs. Group A

Group B vs. Group A

Group C vs. Group A

Group B vs. Group C
By the end of the fifth year from baseline
First hemorrhagic stroke
Time Frame: By the end of the fifth year from baseline
We will examine whether amlodipine folic acid tablets (including Groups B and C), compared to amlodipine alone (Group A), show significantly greater efficacy in preventing first hemorrhagic stroke.
By the end of the fifth year from baseline
First myocardial infarction
Time Frame: By the end of the fifth year from baseline
We will examine whether amlodipine folic acid tablets (including Groups B and C), compared to amlodipine alone (Group A), show significantly greater efficacy in preventing first myocardial infarction.
By the end of the fifth year from baseline
First coronary revascularization (coronary artery bypass grafting [CABG] or percutaneous coronary intervention [PCI])
Time Frame: By the end of the fifth year from baseline
We will examine whether amlodipine folic acid tablets (including Groups B and C), compared to amlodipine alone (Group A), show significantly greater efficacy in preventing first coronary revascularization.
By the end of the fifth year from baseline
Cardiovascular death
Time Frame: By the end of the fifth year from baseline
We will examine whether amlodipine folic acid tablets (including Groups B and C), compared to amlodipine alone (Group A), show significantly greater efficacy in preventing cardiovascular death.
By the end of the fifth year from baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Malignant tumors
Time Frame: By the end of the fifth year of the study
We will examine whether there exist significant differences in efficacy in reducing the risk of malignant tumors between the Groups B + C and Group A.
By the end of the fifth year of the study
All-cause mortality
Time Frame: By the end of the fifth year of the study
We will examine whether there exist significant differences in efficacy in reducing the risk of all-cause mortality between the Groups B + C and Group A.
By the end of the fifth year of the study
Blood pressure levels
Time Frame: 1) Blood pressure levels at one year, three-year and at the end of follow-up(up to 5 years). 2) Average blood pressure levels across all visits in the first and third years of follow-up, as well as for the entire follow-up period (up to 5 years).

We will examine whether there exist significant differences in treatment efficacy on the blood pressure levels between the following pairs of treatment groups:

Groups B + C vs. Group A

Group B vs. Group A

Group C vs. Group A

Group B vs. Group C
1) Blood pressure levels at one year, three-year and at the end of follow-up(up to 5 years). 2) Average blood pressure levels across all visits in the first and third years of follow-up, as well as for the entire follow-up period (up to 5 years).
Blood pressure variability
Time Frame: 1) Average blood pressure variability across all visits in the first and third years of follow-up, and across all visits throughout the entire follow-up period (up to 5 years).

We will examine whether there exist significant differences in treatment efficacy on the blood pressure variability between the following pairs of treatment groups:

Groups B + C vs. Group A

Group B vs. Group A

Group C vs. Group A

Group B vs. Group C
1) Average blood pressure variability across all visits in the first and third years of follow-up, and across all visits throughout the entire follow-up period (up to 5 years).
Blood pressure target achievement rates
Time Frame: 1) Blood pressure target achievementrates at 1-year, 3-year and at the end of follow-up(up to 5 years). 2) Average bloodpressure target achievement rates across all visits in the first and third years of follow-up, and for the entire follow-up period.]

We will examine whether there exist significant differences in treatment efficacy on the blood pressure target achievement rates between the following pairs of treatment groups:

Groups B + C vs. Group A

Group B vs. Group A

Group C vs. Group A

Group B vs. Group C
1) Blood pressure target achievementrates at 1-year, 3-year and at the end of follow-up(up to 5 years). 2) Average bloodpressure target achievement rates across all visits in the first and third years of follow-up, and for the entire follow-up period.]
Serum folate level
Time Frame: Serum folate levels at one year, three-year and at the end of follow-up(up to 5 years).

We will examine whether there exist significant differences in treatment efficacy on the serum folate levels between the following pairs of treatment groups:

Groups B + C vs. Group A

Group B vs. Group A

Group C vs. Group A

Group B vs. Group C
Serum folate levels at one year, three-year and at the end of follow-up(up to 5 years).
Serum folate change
Time Frame: Serum folate changes at one year, three-year and at the end of follow-up(up to 5 years).

We will examine whether there exist significant differences in treatment efficacy on the serum folate changes between the following pairs of treatment groups:

Groups B + C vs. Group A

Group B vs. Group A

Group C vs. Group A

Group B vs. Group C
Serum folate changes at one year, three-year and at the end of follow-up(up to 5 years).
Plasma tHcy level
Time Frame: Plasma total homocysteine levels at one year, three-year and at the end of follow-up(up to 5 years).

We will examine whether there exist significant differences in treatment efficacy on the plasma total homocysteine levels between the following pairs of treatment groups:

Groups B + C vs. Group A

Group B vs. Group A

Group C vs. Group A

Group B vs. Group C
Plasma total homocysteine levels at one year, three-year and at the end of follow-up(up to 5 years).
Plasma tHcy change
Time Frame: Plasma total homocysteine changes at one year, three-year and at the end of follow-up(up to 5 years).

We will examine whether there exist significant differences in treatment efficacy on the plasma total homocysteine changes between the following pairs of treatment groups:

Groups B + C vs. Group A

Group B vs. Group A

Group C vs. Group A

Group B vs. Group C
Plasma total homocysteine changes at one year, three-year and at the end of follow-up(up to 5 years).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shenzhen Ausa Pharmed Co.,Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking University First Hospital
The Affiliated Hospital Of Guizhou Medical University
Second Affiliated Hospital of Nanchang University
Chengdu Fifth People's Hospital
The First People's Hospital of Lianyungang
Tengzhou Central People's Hospital
The Affiliated Hospital Of Southwest Medical University
Weinan Central Hospital
Yancheng First People's Hospital
Bozhou people's hospital
Chizhou people's hospital
Loudi Central Hospital
The First Affiliated Hospital of Gannan Medical University
Lianyungang Oriental Hospital
The First Affiliated Hospital of HuNan University of Medicine
Deyang People's Hospital
Yangjiang People's Hospital
The First Affiliated Hospital of Bengbu Medical University
Shenzhen Prospective Medical Technology Co., LTD
TAIHE country people's hospital
Lianyungang Second People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jianping Li, MD, PhD, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 22, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSPPT2-TT_2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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