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

Primary Purpose

Acute Coronary Syndrome

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Suxiao Jiuxin Pills

The placebo of Suxiao Jiuxin Pills

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Microvascular obstruction, Acute Coronary Syndrome, Percutaneous coronary intervention, Suxiao Jiuxin Pills

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Suxiao Jiuxin Pills

The placebo of Suxiao Jiuxin Pills

Arm Description

Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 180 days

The placebo of Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 180 days

Outcomes

Primary Outcome Measures

Change from baseline myocardial infarct size at 6 months

MI size measure by CMR

Change from baseline incidence of microvascular obstruction at 6 months

Incidence of Microvascular obstruction measure by CMR

Secondary Outcome Measures

Change from baseline incidence of intramyocardial hemorrhagex at 6 months

Incidence of intramyocardial hemorrhagex measure by CMR

Change from baseline incidence of area-at-risk at 6 months

Incidence of area-at-risk measure by CMR

Change of ST segment in electrocardiogram

Change of CK-MB

CK-MB

Change of cTnI

cTnI

Change of NT-proBNP

NT-proBNP

Change of ejection fraction in echocardiography

Ejection fraction measure by echocardiography

Change of 6 Minute Walk Test

6MWT is used to assess aerobic capacity and endurance

Quantitative flow ratio

Index measure by QFR

Incidence of MACCE

Cardiac death, myocardial infarction, stent thrombosis, stroke or transient ischemic attack, urgent revascularization and re-hospitalization for heart failure

Incidence of complications of PCI

Cardiac shock, heart failure, mechanical complications and arrhythmia

Incidence of bleeding event

BARC Type 3 or 4

Incidence of stent restenosis

stent restenosis measure by CMR

Incidence of death event

Any death

Change of Seattle Angina Questionnaire (SAQ)

Seattle Angina Questionnaire (SAQ), the scale has 19 questions, value of each question is from 1 to 6, higher scores mean a better outcome.

Full Information

NCT ID

NCT04814121

First Posted

February 25, 2021

Last Updated

March 22, 2021

Sponsor

Guangzhou University of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04814121

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2021 (Anticipated)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Guangzhou University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

Keywords

Microvascular obstruction, Acute Coronary Syndrome, Percutaneous coronary intervention, Suxiao Jiuxin Pills

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Suxiao Jiuxin Pills

Arm Type

Experimental

Arm Description

Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 180 days

Arm Title

The placebo of Suxiao Jiuxin Pills

Arm Type

Placebo Comparator

Arm Description

The placebo of Suxiao Jiuxin Pills prescription (15 pills loading does, maintenance 6 pills each time, three times a day.) for 180 days

Intervention Type

Drug

Intervention Name(s)

Suxiao Jiuxin Pills

Intervention Description

Suxiao Jiuxin Pills consists Rhizoma Ligustici (Chuan xiong) and Borneolum (Bing pian).

Intervention Type

Drug

Intervention Name(s)

The placebo of Suxiao Jiuxin Pills

Intervention Description

The placebo of Suxiao Jiuxin Pills is similar to Suxiao Jiuxin Pills in appearance, smell, and taste.

Primary Outcome Measure Information:

Title

Change from baseline myocardial infarct size at 6 months

Description

MI size measure by CMR

Time Frame

3-5 days after PCI and 180±7 days

Title

Change from baseline incidence of microvascular obstruction at 6 months

Description

Incidence of Microvascular obstruction measure by CMR

Time Frame

3-5 days after PCI and 180±7 days

Secondary Outcome Measure Information:

Title

Change from baseline incidence of intramyocardial hemorrhagex at 6 months

Description

Incidence of intramyocardial hemorrhagex measure by CMR

Time Frame

3-5 days after PCI and 180±7 days

Title

Change from baseline incidence of area-at-risk at 6 months

Description

Incidence of area-at-risk measure by CMR

Time Frame

3-5 days after PCI and 180±7 days

Title

Change of ST segment in electrocardiogram

Description

Change of ST segment in electrocardiogram

Time Frame

Baseline, immediately after PCI, 5-7 days after PCI, 30±7 days and 180±7 days

Title

Change of CK-MB

Description

CK-MB

Time Frame

Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days

Title

Change of cTnI

Description

cTnI

Time Frame

Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days

Title

Change of NT-proBNP

Description

NT-proBNP

Time Frame

Baseline, immediately after PCI, 5-7 days after PCI, and 180±7 days

Title

Change of ejection fraction in echocardiography

Description

Ejection fraction measure by echocardiography

Time Frame

Baseline, 3-5 days after PCI and 180±7 days

Title

Change of 6 Minute Walk Test

Description

6MWT is used to assess aerobic capacity and endurance

Time Frame

3-5 days after PCI, 30±7 days and 180±7 days

Title

Quantitative flow ratio

Description

Index measure by QFR

Time Frame

During the procedure

Title

Incidence of MACCE

Description

Cardiac death, myocardial infarction, stent thrombosis, stroke or transient ischemic attack, urgent revascularization and re-hospitalization for heart failure

Time Frame

Through study completion, an average of 1 year

Title

Incidence of complications of PCI

Description

Cardiac shock, heart failure, mechanical complications and arrhythmia

Time Frame

Up to 1 month

Title

Incidence of bleeding event

Description

BARC Type 3 or 4

Time Frame

Up to 6 months

Title

Incidence of stent restenosis

Description

stent restenosis measure by CMR

Time Frame

180±7 days

Title

Incidence of death event

Description

Any death

Time Frame

Through study completion, an average of 1 year

Title

Change of Seattle Angina Questionnaire (SAQ)

Description

Seattle Angina Questionnaire (SAQ), the scale has 19 questions, value of each question is from 1 to 6, higher scores mean a better outcome.

Time Frame

baseline, 3-5 days after PCI, 30±7 days, 90±7 days and 180±7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Minzhou Zhang, Professor

Phone

+86-13924266368

minzhouzhang@gzucm.edu.cn

12. IPD Sharing Statement

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

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