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| Name | Class |
|---|---|
| Beijing Municipal Health Bureau | OTHER |
| Haemonetics Corporation | INDUSTRY |
| Zhejiang Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clopidogrel + Aspirit | Active Comparator | A Standard antiplatelet therapy control group: Clopidogrel 75mg Qd + Aspirin 100mg Qd |
|
| Clopidogrel + Aspirin | Active Comparator | B Double-dosage Clopidogrel group: Clopidogrel 150mg Qd + Aspirin 100mg Qd |
|
| Clopidogrel + Aspirin + Cilostazol | Active Comparator | C triple antiplatelet therapy group: Cilostazol 100mg Bid + Aspirin 100mg Qd + Clopidogrel 75mg Qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel 75mg | Drug |
| ||
| Clopidogrel 150mg |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac and cerebrovascular events | MACCE, including cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular events | within 1.5years of patient enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary endpoint | Occurrence of stent thrombosis | within 1.5 years of patients enrolled |
| bleeding | Major bleeding and minor bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuejin Yang, PHD | Chinese Academy of Medical Sciences, Fuwai Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Cardiovascular Hospital | Beijing | 100037 | China | |||
| Fuwai Cardiovascular Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29420189 | Derived | Tang YD, Wang W, Yang M, Zhang K, Chen J, Qiao S, Yan H, Wu Y, Huang X, Xu B, Gao R, Yang Y; CREATIVE Investigators. Randomized Comparisons of Double-Dose Clopidogrel or Adjunctive Cilostazol Versus Standard Dual Antiplatelet in Patients With High Posttreatment Platelet Reactivity: Results of the CREATIVE Trial. Circulation. 2018 May 22;137(21):2231-2245. doi: 10.1161/CIRCULATIONAHA.117.030190. Epub 2018 Feb 2. |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D001241 | Aspirin |
| D000077407 | Cilostazol |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Drug |
|
| Aspirin 100mg | Drug |
|
| Cilostazol 100mg | Drug |
|
| within 1.5 years of patients' enrolled |
| quality of life of patient | to evaluate with Seattle Angina Scale | within 1.5 years of patients' enrolled |
| Beijing |
| China |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D011804 | Quinolines |