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| Name | Class |
|---|---|
| Dong-A Pharmaceutical | INDUSTRY |
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This study demonstrates the effect of generic clopidogrel bisulfate (Plavitor®) in comparison with the original clopidogrel bisulfate (Plavix®) in patients with acute coronary syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| original Clopidogrel Bisulfate (Plavix®) | Active Comparator | original Clopidogrel Bisulfate (Plavix®) 600mg loading |
|
| generic Clopidogrel Bisulfate (Plavitor®) | Experimental | generic Clopidogrel Bisulfate (Plavitor®) 600mg loading |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| generic clopidogrel (Plavitor® ) | Drug |
| ||
| original clopidogrel (Plavix® ) |
| Measure | Description | Time Frame |
|---|---|---|
| PRU level at 2 hours after clopidogrel loading | 2 hours after clopidogrel loading |
| Measure | Description | Time Frame |
|---|---|---|
| PRU level by VerifyNow P2Y12 at 4 -, 8- and 24 hours after clopidogrel loading | 4 -, 8- and 24 hours after clopidogrel loading | |
| ARU level by VerifyNow before and 2 hours after loading | 2 hours after loading |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University Hospital | Suwon | 443-720 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25218311 | Derived | Seo KW, Tahk SJ, Yang HM, Yoon MH, Shin JH, Choi SY, Lim HS, Hwang GS, Choi BJ, Park JS, Shin JS, Lee YH, Choi YW, Park SJ, Jin XJ. Point-of-care measurements of platelet inhibition after clopidogrel loading in patients with acute coronary syndrome: comparison of generic and branded clopidogrel bisulfate. Clin Ther. 2014 Nov 1;36(11):1588-94. doi: 10.1016/j.clinthera.2014.07.018. Epub 2014 Sep 15. |
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| Drug |
|
| Composite of death, myocardial infarction, target vessel revascularization | at 30 days |
| Stent thrombosis by Academic Research Consortium definition | at 30 days |
| Incidence of TIMI major bleedings | at 30 days |
| 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 |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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