Effect of Indobufen and Aspirin on Platelet Aggregation and Long Term Prognosis in Patients With Coronary Heart Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-30

Study Completion Date

2026-12-30

Brief Summary

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This study evaluates the effect of Indobufen and Aspirin on platelet aggregation and long term prognosis in patients with stable coronary heart disease.

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Detailed Description

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Conditions

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Stable Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

The treatment in this study was open. Optical density turbidimetric platelet aggregation (LTA) and thromboelastography (TEG) were used to detect the platelet aggregation rate induced by AA and ADP, and the metabolites were measured by ELISA. All were done by the laboratory personnel, and they were unaware of the setting of treatment medication (blind method).

Study Groups

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Indobufen

200 mg Indobufen, bid po, 90 days

Group Type EXPERIMENTAL

Indobufen

Intervention Type DRUG

Indobufen Tablets

Aspirin

100 mg Aspirin, qd po, 90 days

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

Aspirin Tablets

Interventions

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Indobufen

Indobufen Tablets

Intervention Type DRUG

Aspirin

Aspirin Tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 18 years \< age ≤ 85 years;
2. Patients with confirmed stable coronary heart disease (must meet at least one of the following conditions);

2.1 a stenosis confirmed by Coronary angiography or dual-source CT, but the stenosis of the Left Main Artery (LMA) diameter is less than 50%, the stenosis of the left anterior descending branch（LAD）is less than 70%, and the stenosis of the two or three coronary arteries diameter is less than 70%, patient has no corresponding evidence of ischemia;

2.2 Patients after percutaneous coronary intervention (PCI): Dual antiplatelet therapy (DAPT) time is greater than 9 months, without cardiovascular events and ischemic symptoms; and currently receiving aspirin 100 mg/d with clopidogrel 75 mg/d or ticagrelor 90mg (bid) dual antiplatelet therapy.

2.3 Patients after coronary artery bypass graft (CABG): Dual antiplatelet therapy (DAPT) time is greater than 9 months, without cardiovascular events and ischemic symptoms; and currently receiving aspirin 100 mg/d with clopidogrel 75 mg/d or ticagrelor 90mg (bid) dual antiplatelet therapy.
3. Willing to sign the informed consent.

Exclusion Criteria

1. Acute coronary syndrome (ACS) occurred within 3 months before screening;
2. Percutaneous coronary intervention or CABG surgery within 9 months before screening;
3. Any other conditions (such as atrial fibrillation, pulmonary embolism, lower extremity venous thrombosis, artificial heart valve, etc.) who need oral or intravenous anticoagulation treatment;
4. In the past 3 months, the Arachidonic acid-induced platelet aggregation rate≥ 50%; inhibition rate ≤ 20% in the aspirin combined with clopidogrel treated patients;
5. Congestive heart failure or left ventricular ejection fraction \<35%;
6. A positive history of Chronic Obstructive Pulmonary Disease (COPD);
7. bleeding tendency or severe lung disease;
8. Active pathological bleeding;
9. History of intracranial hemorrhage (less than 3 months);
10. Allergic to indobufen / aspirin (or any of its ingredients);
11. Severe liver injury (transaminases exceeding the upper limit of 2 times and above);
12. Pregnancy, lactation and those who have a birth plan;
13. Hematological diseases, platelet count \<100000 / mm3 or hemoglobin \<10g / dL;
14. Have a history of drug or alcohol abuse in the past 2 years;
15. Use of non-steroidal anti-inflammatory drugs (within 3 months);
16. Creatinine clearance \<30ml/min;

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No