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

Not Applicable

Completed

• Conditions: Coronary Heart Disease
• Interventions: Drug: Clopidogrel 75mg; Drug: Clopidogrel 150mg; Drug: Aspirin 100mg; Drug: Cilostazol 100mg

• Registration Number: NCT01779401
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-30
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1078

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clopidogrel + Aspirit	Clopidogrel 75mg	A Standard antiplatelet therapy control group： Clopidogrel 75mg Qd + Aspirin 100mg Qd
Clopidogrel + Aspirin	Clopidogrel 150mg	B Double-dosage Clopidogrel group： Clopidogrel 150mg Qd + Aspirin 100mg Qd
Clopidogrel + Aspirin	Aspirin 100mg	B Double-dosage Clopidogrel group： Clopidogrel 150mg Qd + Aspirin 100mg Qd
Clopidogrel + Aspirin + Cilostazol	Aspirin 100mg	C triple antiplatelet therapy group： Cilostazol 100mg Bid + Aspirin 100mg Qd + Clopidogrel 75mg Qd
Clopidogrel + Aspirin + Cilostazol	Clopidogrel 75mg	C triple antiplatelet therapy group： Cilostazol 100mg Bid + Aspirin 100mg Qd + Clopidogrel 75mg Qd
Clopidogrel + Aspirit	Aspirin 100mg	A Standard antiplatelet therapy control group： Clopidogrel 75mg Qd + Aspirin 100mg Qd
Clopidogrel + Aspirin + Cilostazol	Cilostazol 100mg	C triple antiplatelet therapy group： Cilostazol 100mg Bid + Aspirin 100mg Qd + Clopidogrel 75mg Qd

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac and cerebrovascular events	within 1.5years of patient enrolled	MACCE, including cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular events

Secondary Outcome Measures

Name	Time	Method
Secondary endpoint	within 1.5 years of patients enrolled	Occurrence of stent thrombosis
bleeding	within 1.5 years of patients' enrolled	Major bleeding and minor bleeding
quality of life of patient	within 1.5 years of patients' enrolled	to evaluate with Seattle Angina Scale

Trial Locations

Locations (1)

Fuwai Cardiovascular Hospital; 🇨🇳 Beijing, China