Clopidogrel Response Evaluation and AnTi-Platelet InterVEntion in High Thrombotic Risk PCI Patients

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

COMPLETED

Clinical Phase

NA

Total Enrollment

1078 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-09-30

Brief Summary

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To identify the high-risk patients who might have in-stent thrombosis after PCI with thromboelastography and to head-to-head compare two intensified antiplatelet therapeutic strategies of double-dosage Clopidogrel and triple antiplatelet therapy with Cilostazol with the standard antiplatelet therapy.

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Detailed Description

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Study population: Age 18 - 75, male or non-pregnant female; stable or unstable angina with evidence of myocardial ischemia, or patient with myocardial infarction; coronary angiography reveals stenosis lesions; discovery of ADP induced platelet inhibition rate \< 50% and MAADP \> 47mm via thromboelastography (indicating low responsiveness to Clopidogrel with high risk for stent thrombosis formation); is able to understand the objective of the trial, takes part voluntarily and signs the written informed consent form.

Conditions

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Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Clopidogrel + Aspirit

A Standard antiplatelet therapy control group： Clopidogrel 75mg Qd + Aspirin 100mg Qd

Group Type ACTIVE_COMPARATOR

Clopidogrel 75mg

Intervention Type DRUG

Aspirin 100mg

Intervention Type DRUG

Clopidogrel + Aspirin

B Double-dosage Clopidogrel group： Clopidogrel 150mg Qd + Aspirin 100mg Qd

Group Type ACTIVE_COMPARATOR

Clopidogrel 150mg

Intervention Type DRUG

Aspirin 100mg

Intervention Type DRUG

Clopidogrel + Aspirin + Cilostazol

C triple antiplatelet therapy group： Cilostazol 100mg Bid + Aspirin 100mg Qd + Clopidogrel 75mg Qd

Group Type ACTIVE_COMPARATOR

Clopidogrel 75mg

Intervention Type DRUG

Aspirin 100mg

Intervention Type DRUG

Cilostazol 100mg

Intervention Type DRUG

Interventions

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Clopidogrel 75mg

Intervention Type DRUG

Clopidogrel 150mg

Intervention Type DRUG

Aspirin 100mg

Intervention Type DRUG

Cilostazol 100mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age 18 - 75, male or non-pregnant female;
2. Stable or unstable angina with evidence of myocardial ischemia, or patient with myocardial infarction;
3. Coronary angiography reveals stenosis lesions;
4. Discovery of ADP induced platelet inhibition rate \< 50% and MAADP \>47mm via thromboelastography (indicating low responsiveness to Clopidogrel with high risk for stent thrombosis formation);
5. Is able to understand the objective of the trial, takes part voluntarily and signs the written informed consent form.

Exclusion Criteria

1. Those who have participated in other drug or therapy equipment clinical trials but did not reach the main study endpoint time limit;
2. Symptoms of severe heart failure (NYHA Class III and above) or left ventricular ejection fraction \< 40% (ultrasound or left ventricle ngiography);
3. Pregnant or lactating women;
4. severely impaired renal function before surgery: serum creatinine \> 2.0mg/dl;
5. Impaired liver function before surgery: Serum GPT \> 120U/L;
6. Bleeding tendency, history of active peptic ulcer, history of cerebral hemorrhage or cavum subarachnoidale bleeding, patients with antiplatelet agent and anticoagulant treatment contraindications and hence are unable to undergo anticoagulant therapy;
7. Patients who are unable to withstand dual antiplatelet therapy due to allergy to Aspirin, Clopidogrel or ticlopidine, heparin, contrast agent, paclitaxel and metals;
8. Leucocyte \< 3.5 x 109; and/or platelet \< 100,000/mm3 or \> 750,000/mm3;
9. Patient's life expectancy is less than 12 months;
10. Patients who plan to undergo coronary artery bypass grafting or other surgery within 1 year;
11. Those waiting for heart transplant;
12. Patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No