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

Study Overview
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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.

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.

Official Title
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Investigator Initiated Prospective Study to Investigate the Best Anti-platelet Treatment in High Thrombotic Risk PCI Patients.

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Drug: Clopidogrel 75mg
* Drug: Clopidogrel 150mg
* Drug: Aspirin 100mg
* Drug: Cilostazol 100mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Those who have participated in other drug or therapy equipment clinical trials but did not reach the main study endpoint time limit; Symptoms of severe heart failure (NYHA Class III and above) or left ventricular ejection fraction < 40% (ultrasound or left ventricle ngiography); Pregnant or lactating women; severely impaired renal function before surgery: serum creatinine > 2.0mg/dl; Impaired liver function before surgery: Serum GPT > 120U/L; 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; Patients who are unable to withstand dual antiplatelet therapy due to allergy to Aspirin, Clopidogrel or ticlopidine, heparin, contrast agent, paclitaxel and metals; Leucocyte < 3.5 x 109; and/or platelet < 100,000/mm3 or > 750,000/mm3; Patient's life expectancy is less than 12 months; Patients who plan to undergo coronary artery bypass grafting or other surgery within 1 year; Those waiting for heart transplant; Patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clopidogrel + Aspirit<br>A Standard antiplatelet therapy control group： Clopidogrel 75mg Qd + Aspirin 100mg Qd | Drug: Clopidogrel 75mg<br> <br> Drug: Aspirin 100mg<br> <br> |
| Active Comparator: Clopidogrel + Aspirin<br>B Double-dosage Clopidogrel group： Clopidogrel 150mg Qd + Aspirin 100mg Qd | Drug: Clopidogrel 150mg<br> <br> Drug: Aspirin 100mg<br> <br> |
| Active Comparator: Clopidogrel + Aspirin + Cilostazol<br>C triple antiplatelet therapy group： Cilostazol 100mg Bid + Aspirin 100mg Qd + Clopidogrel 75mg Qd | Drug: Clopidogrel 75mg<br> <br> Drug: Aspirin 100mg<br> <br> Drug: Cilostazol 100mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac and cerebrovascular events | MACCE, including cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular events | within 1.5years of patient enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary endpoint | Occurrence of stent thrombosis | within 1.5 years of patients enrolled | 
| bleeding | Major bleeding and minor bleeding | within 1.5 years of patients' enrolled | 
| quality of life of patient | to evaluate with Seattle Angina Scale | within 1.5 years of patients' enrolled | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCI, platelet function monitoring, Thrombelastography, clopidogrel, cilostazol, in-stent thrombosis