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The study aims to assess the effectiveness of dual antiplatelet therapy, aspirin alone versus steeply discontinued clopidogrel plus aspirin in preventing clinical MACE events.Our subject is beyond a 12-month period patients receiving sirolimus drug-eluting stent implantation.
It is not clear that dual antiplatelet therapy is better than aspirin beyond 12-months period patients receiving sirolimus drug-eluting stent implantation. If aspirin plus clopidogrel reduced MACE rates without increasing blood events, the investigators will evaluate risk-benefit ratio. The investigators will observe all cause mortality, nonfatal myocardial infarction, or clinical-driven target vessel revascularization TVR in a 1-year trial duration. In addition, strokes, stent thrombosis, cardiac re-hospitalizations, dialysis/hemofiltration, duration of hospitalization and bleeding events will be observed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clopidogrel | Experimental |
| |
| placebo | Placebo Comparator |
| |
| steply discontinued clopidogrel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clopidogrel | Drug | clopidogrel 75 mg po per day for 12 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| all cause mortality | one year | |
| nonfatal myocardial infarction | one year | |
| clinical-driven target vessel revascularization | one year | |
| cardiac death | one year | |
| stent thrombosis | one year |
| Measure | Description | Time Frame |
|---|---|---|
| death | one year | |
| myocardial infarction | one year | |
| any repeat revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| He Huang, Doctor of Medicine | Contact | 860571-86006246 | huanghell@163.com | |
| Guo-sheng Fu, Doctor of Philosopy | Contact | 860571-86006490 | fugs64@gmail.com |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| placebo |
| Drug |
placebo 75mg po per day for 12 months |
|
| clopidogrel and placebo | Drug | clopidogrel 50mg per day for 3 months,clopidogrel 25mg per day for 3 months,then placebo 75mg per day for 6 months |
|
| one year |
| strokes | one year |
| dialysis/hemofiltration | one year |
| bleeding events | one year |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |