Overview

This trial is active, not recruiting.

Condition coronary heart disease
Treatments clopidogrel 75mg, clopidogrel 150mg, aspirin 100mg, cilostazol 100mg
Sponsor Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborator Beijing Municipal Health Bureau
Start date September 2012
End date September 2016
Trial size 1050 participants
Trial identifier NCT01779401, 2011-4003-03

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
A Standard antiplatelet therapy control group: Clopidogrel 75mg Qd + Aspirin 100mg Qd
clopidogrel 75mg
aspirin 100mg
(Active Comparator)
B Double-dosage Clopidogrel group: Clopidogrel 150mg Qd + Aspirin 100mg Qd
clopidogrel 150mg
aspirin 100mg
(Active Comparator)
C triple antiplatelet therapy group: Cilostazol 100mg Bid + Aspirin 100mg Qd + Clopidogrel 75mg Qd
clopidogrel 75mg
aspirin 100mg
cilostazol 100mg

Primary Outcomes

Measure
Major adverse cardiac and cerebrovascular events
time frame: within 1.5years of patient enrolled

Secondary Outcomes

Measure
Secondary endpoint
time frame: within 1.5 years of patients enrolled
bleeding
time frame: within 1.5 years of patients' enrolled
quality of life of patient
time frame: within 1.5 years of patients' enrolled

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title Investigator Initiated Prospective Study to Investigate the Best Anti-platelet Treatment in High Thrombotic Risk PCI Patients.
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Chinese Academy of Medical Sciences, Fuwai Hospital.