Suxiao Jiuxin Pills in Microvascular Obstruction in Patients With Acute Coronary Syndrome

March 22, 2021 updated by: Guangzhou University of Traditional Chinese Medicine
Microvascular obstruction is the severe complication of percutaneous coronary intervention (PCI) in patients with acute coronary syndrome. Microvascular obstruction after PCI is often association with poor prognosis. Current treatments do not show improvement in prognosis of microvascular obstruction. Suxiao Jiuxin Pills (SXJX) was shown associated with a reduction in MACE, and an improvement of heart function and quality of life in acute coronary syndrome (ACS) patients with early PCI. To evaluate the effectiveness and safety of SXJX in microvascular obstruction after PCI, the investigators designed this study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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.

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 (Anticipated)

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.
198

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.

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:

  • Meet the diagnosis of AMI, prepare for PCI reperfusion therapy;
  • Between the ages of 18-75;
  • Volunteer to participate in this study and have signed an informed consent form;
  • Have a correct understanding of the significance of drug research, and have a good compliance with the observation and evaluation.

Exclusion Criteria:

  • Not suitable for coronary intervention;
  • With unstable hemodynamics;
  • Platelet count<100×109;
  • Suspected aortic dissection or acute pulmonary embolism;
  • With mechanical complications;
  • With uncontrolled acute left heart failure and pulmonary edema;
  • With known bleeding history, active bleeding, bleeding constitution, or severe hemostatic and coagulation dysfunction;
  • Meantain anticoagulants (such as warfarin or new anticoagulants);
  • Severe liver and kidney insufficiency (Child-Pugh B and above, Cr>177μmol/L (2mg/dl) or eGFR<45ml/min/1.73m2);
  • CTO, stent stenosis, or severe left main disease;
  • History of coronary artery bypass graft surgery;
  • Other pathophysiological conditions whose expected survival period is less than 1 year;
  • Allergic history to Suxiao Jiuxin Pills;
  • Pregnant or lactating women;
  • Participating in other clinical studies;
  • With other diseases that are not suitable for participating in clinical research.

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.
Experimental: Suxiao Jiuxin Pills
Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 180 days
Drug: Suxiao Jiuxin Pills
Suxiao Jiuxin Pills consists Rhizoma Ligustici (Chuan xiong) and Borneolum (Bing pian).
Placebo Comparator: The placebo of Suxiao Jiuxin Pills
The placebo of Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 180 days
Drug: The placebo of Suxiao Jiuxin Pills
The placebo of Suxiao Jiuxin Pills is similar to Suxiao Jiuxin Pills in appearance, smell, and taste.

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
Change from baseline myocardial infarct size at 6 months
Time Frame: 3-5 days after PCI and 180±7 days
MI size measure by CMR
3-5 days after PCI and 180±7 days
Change from baseline incidence of microvascular obstruction at 6 months
Time Frame: 3-5 days after PCI and 180±7 days
Incidence of Microvascular obstruction measure by CMR
3-5 days after PCI and 180±7 days

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
Change from baseline incidence of intramyocardial hemorrhagex at 6 months
Time Frame: 3-5 days after PCI and 180±7 days
Incidence of intramyocardial hemorrhagex measure by CMR
3-5 days after PCI and 180±7 days
Change from baseline incidence of area-at-risk at 6 months
Time Frame: 3-5 days after PCI and 180±7 days
Incidence of area-at-risk measure by CMR
3-5 days after PCI and 180±7 days
Change of ST segment in electrocardiogram
Time Frame: Baseline, immediately after PCI, 5-7 days after PCI, 30±7 days and 180±7 days
Change of ST segment in electrocardiogram
Baseline, immediately after PCI, 5-7 days after PCI, 30±7 days and 180±7 days
Change of CK-MB
Time Frame: Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days
CK-MB
Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days
Change of cTnI
Time Frame: Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days
cTnI
Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days
Change of NT-proBNP
Time Frame: Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days
NT-proBNP
Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days
Change of ejection fraction in echocardiography
Time Frame: Baseline, 3-5 days after PCI and 180±7 days
Ejection fraction measure by echocardiography
Baseline, 3-5 days after PCI and 180±7 days
Change of 6 Minute Walk Test
Time Frame: 3-5 days after PCI, 30±7 days and 180±7 days
6MWT is used to assess aerobic capacity and endurance
3-5 days after PCI, 30±7 days and 180±7 days
Quantitative flow ratio
Time Frame: During the procedure
Index measure by QFR
During the procedure
Incidence of MACCE
Time Frame: Through study completion, an average of 1 year
Cardiac death, myocardial infarction, stent thrombosis, stroke or transient ischemic attack, urgent revascularization and re-hospitalization for heart failure
Through study completion, an average of 1 year
Incidence of complications of PCI
Time Frame: Up to 1 month
Cardiac shock, heart failure, mechanical complications and arrhythmia
Up to 1 month
Incidence of bleeding event
Time Frame: Up to 6 months
BARC Type 3 or 4
Up to 6 months
Incidence of stent restenosis
Time Frame: 180±7 days
stent restenosis measure by CMR
180±7 days
Incidence of death event
Time Frame: Through study completion, an average of 1 year
Any death
Through study completion, an average of 1 year
Change of Seattle Angina Questionnaire (SAQ)
Time Frame: baseline, 3-5 days after PCI, 30±7 days, 90±7 days and 180±7 days
Seattle Angina Questionnaire (SAQ), the scale has 19 questions, value of each question is from 1 to 6, higher scores mean a better outcome.
baseline, 3-5 days after PCI, 30±7 days, 90±7 days and 180±7 days

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.
Guangzhou University of Traditional Chinese Medicine

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 (Anticipated)

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.
May 1, 2021

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.
September 30, 2023

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.
September 30, 2023

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).
February 25, 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.
March 22, 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.
March 24, 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 24, 2021

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.
March 22, 2021

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.
March 1, 2021

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.
  • 2020KT1715

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings