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

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Completed

Conditions: Coronary Heart Disease

Treatments: Drug: Clopidogrel 75mg; Drug: Cilostazol 100mg; Drug: Aspirin 100mg; Drug: Clopidogrel 150mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01779401

2011-4003-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,078 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,078 participants in 3 patient groups

Clopidogrel + Aspirit

Active Comparator group

Description:

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

Treatment:

Drug: Clopidogrel 75mg

Drug: Aspirin 100mg

Clopidogrel + Aspirin

Active Comparator group

Description:

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

Treatment:

Drug: Clopidogrel 150mg

Drug: Aspirin 100mg

Clopidogrel + Aspirin + Cilostazol

Active Comparator group

Description:

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

Treatment:

Drug: Clopidogrel 75mg

Drug: Aspirin 100mg

Drug: Cilostazol 100mg