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Clopidogrel resistance (CR) or low-responsiveness is associated with increased risk of ischemic events and can be detected by laboratory tests. This multicenter, randomized study is aimed to explore the efficacy and safety of intensive antiplatelet therapy (i.e. double clopidogrel maintenance dose and/or additional cilostazol)for patients with CR after coronary stenting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard group | Active Comparator | patients in this group received standard dual antiplatelet therapy, i.e. aspirin 300mg/d and clopidogrel 75mg/d |
|
| intensive group | Experimental | patients in this group received intensive antiplatelet therapy and the regimen can be adjusted according to results of platelet aggregation function test by LTA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aspirin, clopidogrel | Drug | patients in the standard group received standard dual antiplatelet therapy: aspirin 300mg/d for 30 days followed by 100mg/d indefinitely, clopidogrel 75mg/d for at least 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Major ischemic cardiovascular events | defined as a composite of cardiac death, myocardial infarction or stroke | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Stent thrombosis | according to ARC definition | 1 year |
| major adverse cardiac and cerebral events(MACCE) | defined as a composite of cardiac death, myocardial infarction, target vessel revascularization or stroke |
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Inclusion Criterial:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yaling Han, MD | Shenyang Northern Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 463 Hospital of PLA | Shenyang | Liaoning | 110000 | China | ||
| Shengjing Hospital of China Medical University |
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| aspirin, clopidogrel, cilostazol | Drug | Firstly,all patients in this group were received aspirin 300mg/d and clopidogrel 150mg/d for 3 days. Then a platelet aggregation function test was performed. The regimen will lasted for another 27 days if patients were judged as responsive to current clopidogrel dose. Patients still with clopidogrel resistance were then randomly assigned to receive clopidogrel 75mg/d plus cilostazol 100mg, twice per day or clopidogrel 150mg/d plus cilostazol 50mg, twice per day for 27 days. At 30-day, a repeat platelet aggregation function test wil performed for all patients. Then a standard dual antiplatelet regimen with aspirin 100mg/d indefinitely and clopidogrel 75mg/d for at least 1 year will be prescribed for all patients. |
|
| 1 year |
| Hemorrhagic events | according to TIMI bleeding definition | within 1 year |
| reduction in ADP induced platelet aggregation | assessed by LTA (Packs-4 Aggregometer, Helena labs, Beaumont, Texas) | 30 days |
| Shenyang |
| Liaoning |
| 110016 |
| China |
| Shenyang Northern Hospital | Shenyang | Liaoning | 110840 | China |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| D000077407 | Cilostazol |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D011804 | Quinolines |
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