Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia

January 31, 2018 updated by: Jinming Yu, Fudan University

Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia: A Network Register-based Follow-up Study

This study is designed to verify the clinical efficacy and safety of different statins in dyslipidemia patients, and explore the effects on glycometabolic in patients with impaired glucose regulation.

Study Overview

Status

Status

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

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

Study Objective:

  1. The main Objective: To explore the effects of different statins lipid-lowering treatment on glucose metabolism in patients with impaired glucose regulation in a large sample of Chinese population;
  2. The secondary Objective: To obtain real-world evidence of the clinical efficacy and safety of statins lipid-lowering therapy in Chinese patients.

Study Design: The study was an open-label, multi-center network register-based follow-up study.

The total sample size: 10000 participants.

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 (Actual)

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.
10000

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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Heart Center of Peking University People's Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • School of Public Health, Fudan University

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with a clinical diagnosis of ASCVD (Acute coronary syndrome, Stable coronary heart disease, Postoperative revascularization, Ischemic cardiomyopathy, Ischemic stroke, Transient ischemic attack, Peripheral atherosclerotic disease).
  2. ASCVD overall risk assessment for high-risk groups: Diabetic patients with LDL-C≥1.8mmol/L（70mg/dl）and age was equal or greater than 40 years old;
  3. Patients with hypertension, LDL-C > 2.6mmol/L (100mg/dL) and combined with at least two risk factors. Risk factors include smoking, low HDL-C (HDL-C<1mmol/L, 40mg/dL), male aged over 45 years old or female aged over 55 years old; *** The above (1)-(3) are juxtapositions, patients can be included into the group if only they are satisfied with at least one of the inclusion criteria.

Exclusion Criteria:

  1. Patients with any allergy to statins;
  2. ACS patients in acute stage；
  3. Patients with severe liver disease or biliary obstruction；
  4. Patients taking cyclosporine；
  5. Patients who have being treated with statins currently or in the past;
  6. Pregnant or lactating women and those women who planning to be pregnant;
  7. Immunodeficiency or Immunocompromised patients;
  8. Patients with hypothyroidism (expect those patients whose thyroid function returned to normal level after drug therapy);
  9. Patients using systemic hormone drug;
  10. Researchers decided that the patients who was not suitable to participate in the study.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
Experimental: Pitavastatin treatment
The drug pitavastatin is given to the patient according to the doctor's order and restricted to BangZhi produced by Jiangsu Wanbang Medicine Marketing Co., Ltd..
Drug: Pitavastatin
Capsule/Tablet, oral, follow the doctor's advice Participants will receive pitavastatin treatment for 3 or 12 weeks.
Experimental: Atorvastatin treatment
The drug atorvastatin is given to the patient according to the doctor's order and the drug band is unspecified.
Drug: Atorvastatin
Capsule/Tablet, oral, follow the doctor's advice Participants will receive atorvastatin treatment for 3 or 12 weeks.
Experimental: Rosuvastatin treatment
The drug atorvastatin is given to the patient according to the doctor's order and the drug band is unspecified.
Drug: Rosuvastatin
Capsule/Tablet, oral, follow the doctor's advice Participants will receive rosuvastatin treatment for 3 or 12 weeks.

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
LDL-C target achieving rate
Time Frame: 3 months
To measure the levels of LDL-C in mmol/L and calculate the LDL-C target achieving rate.
3 months

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
Blood lipid parameters
Time Frame: 3 months
The levels of total cholesterol (TC) in mmol/L
3 months
Blood lipid parameters
Time Frame: 3 months
The levels of triglyceride (TG) in mmol/L
3 months
Blood lipid parameters
Time Frame: 3 months
The levels of low density lipoprotein cholesterol (LDL-C) in mmol/L
3 months
Blood glucose levels
Time Frame: 1 year
To measure the level of glycosylated hemoglobin (HbA1) in percent (%)
1 year
Fasting blood glucose
Time Frame: 1 year
The levels of fasting blood glucose (FBG) in mmol/L
1 year
Blood lipid parameters
Time Frame: 1 year
The levels of total cholesterol (TC) in mmol/L
1 year
Blood lipid parameters
Time Frame: 1 year
The levels of triglyceride (TG) in mmol/L
1 year
Blood lipid parameters
Time Frame: 1 year
The levels of low density lipoprotein cholesterol (LDL-C) in mmol/L
1 year
Blood lipid parameters
Time Frame: 1 year
The levels of High density lipoprotein cholesterol (HDL-C) in mmol/L
1 year
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Through study completion, an average of 1 year
To evaluate the safety and tolerability of the three statins, the incidence of treatment-emergent adverse events should be recorded though the study.
Through study completion, an average of 1 year

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.
Fudan University

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 People's Hospital
Jiangsu Wanbang Medicine Marketing Co., Ltd.

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: Yuming Jin, Professor, School of Public Health，Fudan University
  • Principal Investigator: Dayi Hu, Professor, Director of Department of Cardiology, Peking University People's Hospital; Director of Institute of Cardiovascular Disease, Peking University

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.
November 1, 2017

Primary Completion (Anticipated)

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.
December 31, 2021

Study Completion (Anticipated)

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.
December 31, 2021

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).
January 14, 2018

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.
January 31, 2018

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.
February 1, 2018

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.
February 1, 2018

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.
January 31, 2018

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.
January 1, 2018

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.
  • BZ1701

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

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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