ClinicalTrials.gov processed this data on March 28, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT017794012011-4003-03NCT01779401Clopidogrel Response Evaluation and AnTi-Platelet InterVEntion in High Thrombotic Risk PCI Patients
CREATIVE
Investigator Initiated Prospective Study to Investigate the Best Anti-platelet Treatment in High Thrombotic Risk PCI Patients.Chinese Academy of Medical Sciences, Fuwai HospitalOtherBeijing Municipal Health BureauOtherHaemonetics CorporationIndustryZhejiang Otsuka Pharmaceutical Co., Ltd.IndustryYes
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.
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.
CompletedSeptember 2012September 2016September 2016N/AInterventionalNoRandomizedParallel AssignmentTreatmentNone (Open Label)Major adverse cardiac and cerebrovascular eventswithin 1.5years of patient enrolledMACCE, including cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular eventsSecondary endpointwithin 1.5 years of patients enrolledOccurrence of stent thrombosisbleedingwithin 1.5 years of patients' enrolledMajor bleeding and minor bleedingquality of life of patientwithin 1.5 years of patients' enrolledto evaluate with Seattle Angina Scale31078Coronary Heart DiseaseClopidogrel + AspiritActive ComparatorA Standard antiplatelet therapy control group: Clopidogrel 75mg Qd + Aspirin 100mg QdClopidogrel + AspirinActive ComparatorB Double-dosage Clopidogrel group: Clopidogrel 150mg Qd + Aspirin 100mg QdClopidogrel + Aspirin + CilostazolActive ComparatorC triple antiplatelet therapy group: Cilostazol 100mg Bid + Aspirin 100mg Qd + Clopidogrel 75mg QdDrugClopidogrel 75mgClopidogrel + Aspirin + CilostazolClopidogrel + AspiritDrugClopidogrel 150mgClopidogrel + AspirinDrugAspirin 100mgClopidogrel + AspirinClopidogrel + Aspirin + CilostazolClopidogrel + AspiritDrugCilostazol 100mgClopidogrel + Aspirin + Cilostazol
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.
All18 Years75 YearsNoYuejin Yang, PHDStudy ChairFuwai Hospital, CAMS & PUMCFuwai Cardiovascular HospitalBeijing100037ChinaFuwai Cardiovascular HospitalBeijingChinaChinaJuly 2017January 15, 2013January 28, 2013January 30, 2013July 18, 2017July 18, 2017July 19, 2017Principal InvestigatorChinese Academy of Medical Sciences, Fuwai HospitalYi-Da TangProfessorPCIplatelet function monitoringThrombelastographyclopidogrelcilostazolin-stent thrombosisHeart DiseasesCoronary DiseaseCoronary Artery DiseaseMyocardial IschemiaAspirinCilostazolClopidogrel