Coronary Heart Disease
Conditions
Keywords
PCI, platelet function monitoring, Thrombelastography, clopidogrel, cilostazol, in-stent thrombosis
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.
Interventions
Sponsors
Beijing Municipal Health Bureau
Haemonetics Corporation
Zhejiang Otsuka Pharmaceutical Co., Ltd.
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed