Clopidogrel Response Evaluation and AnTi-Platelet InterVEntion in High Thrombotic Risk PCI Patients (CREATIVE)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Coronary Heart Disease |
Drug: Clopidogrel 75mg Drug: Clopidogrel 150mg Drug: Aspirin 100mg Drug: Cilostazol 100mg |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Investigator Initiated Prospective Study to Investigate the Best Anti-platelet Treatment in High Thrombotic Risk PCI Patients. |
- Major adverse cardiac and cerebrovascular events [ Time Frame: within 1.5years of patient enrolled ] [ Designated as safety issue: Yes ]MACCE, including cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular events
- Secondary endpoint [ Time Frame: within 1.5 years of patients enrolled ] [ Designated as safety issue: Yes ]Occurrence of stent thrombosis
- bleeding [ Time Frame: within 1.5 years of patients' enrolled ] [ Designated as safety issue: Yes ]Major bleeding and minor bleeding
- quality of life of patient [ Time Frame: within 1.5 years of patients' enrolled ] [ Designated as safety issue: No ]to evaluate with Seattle Angina Scale
| Estimated Enrollment: | 1050 |
| Study Start Date: | September 2012 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Clopidogrel + Aspirit
A Standard antiplatelet therapy control group: Clopidogrel 75mg Qd + Aspirin 100mg Qd
|
Drug: Clopidogrel 75mg Drug: Aspirin 100mg |
|
Active Comparator: Clopidogrel + Aspirin
B Double-dosage Clopidogrel group: Clopidogrel 150mg Qd + Aspirin 100mg Qd
|
Drug: Clopidogrel 150mg Drug: Aspirin 100mg |
|
Active Comparator: Clopidogrel + Aspirin + Cilostazol
C triple antiplatelet therapy group: Cilostazol 100mg Bid + Aspirin 100mg Qd + Clopidogrel 75mg Qd
|
Drug: Clopidogrel 75mg Drug: Aspirin 100mg Drug: Cilostazol 100mg |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Those who have participated in other drug or therapy equipment clinical trials but did not reach the main study endpoint time limit;
- Symptoms of severe heart failure (NYHA Class III and above) or left ventricular ejection fraction < 40% (ultrasound or left ventricle ngiography);
- Pregnant or lactating women;
- severely impaired renal function before surgery: serum creatinine > 2.0mg/dl;
- Impaired liver function before surgery: Serum GPT > 120U/L;
- 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;
- Patients who are unable to withstand dual antiplatelet therapy due to allergy to Aspirin, Clopidogrel or ticlopidine, heparin, contrast agent, paclitaxel and metals;
- Leucocyte < 3.5 x 109; and/or platelet < 100,000/mm3 or > 750,000/mm3;
- Patient's life expectancy is less than 12 months;
- Patients who plan to undergo coronary artery bypass grafting or other surgery within 1 year;
- Those waiting for heart transplant;
- Patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.
Contacts and Locations| Contact: Yida Tang, PHD | 86 113701018290 | tangyida@gmail.com |
| China | |
| Fuwai Cardiovascular Hospital | Recruiting |
| Beijing, China, 100037 | |
| Contact: Min Yang, Master 86 18610433489 yangminfw@gmail.com | |
| Principal Investigator: Yida Tang, MDs | |
| Study Chair: | Yuejin Yang, PHD | Fuwai Hospital, CAMS & PUMC |
More Information
No publications provided
| Responsible Party: | Yi-Da Tang, Professor, Cardiovascular Institute & Fuwai Hospital |
| ClinicalTrials.gov Identifier: | NCT01779401 History of Changes |
| Other Study ID Numbers: | 2011-4003-03 |
| Study First Received: | January 15, 2013 |
| Last Updated: | January 28, 2013 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Cardiovascular Institute & Fuwai Hospital:
|
PCI platelet function monitoring Thrombelastography |
clopidogrel cilostazol in-stent thrombosis |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Aspirin Cilostazol Ticlopidine Clopidogrel Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013