Abstract | BACKGROUND: METHODS: The CURRENT-OASIS 7 trial was undertaken in 597 centres in 39 countries. 25,086 individuals with acute coronary syndromes and intended early PCI were randomly assigned to double-dose (600 mg on day 1, 150 mg on days 2-7, then 75 mg daily) versus standard-dose (300 mg on day 1 then 75 mg daily) clopidogrel, and high-dose (300-325 mg daily) versus low-dose (75-100 mg daily) aspirin. Randomisation was done with a 24 h computerised central automated voice response system. The clopidogrel dose comparison was double-blind and the aspirin dose comparison was open label with blinded assessment of outcomes. This prespecified analysis is of the 17,263 individuals who underwent PCI. The primary outcome was cardiovascular death, myocardial infarction, or stroke at 30 days. Analyses were by intention to treat, adjusted for propensity to undergo PCI. This trial is registered with ClinicalTrials.gov, number NCT00335452. FINDINGS: 8560 patients were assigned to double-dose and 8703 to standard-dose clopidogrel (8558 and 8702 completed 30-day follow-up, respectively), and 8624 to high-dose and 8639 to low-dose aspirin (8622 and 8638 completed 30-day follow-up, respectively). Compared with the standard dose, double-dose clopidogrel reduced the rate of the primary outcome (330 events [3·9%] vs 392 events [4·5%]; adjusted hazard ratio 0·86, 95% CI 0·74-0·99, p=0·039) and definite stent thrombosis (58 [0·7%] vs 111 [1·3%]; 0·54 [0·39-0·74], p=0·0001). High-dose and low-dose aspirin did not differ for the primary outcome (356 [4·1%] vs 366 [4·2%]; 0·98, 0·84-1·13, p=0·76). Major bleeding was more common with double-dose than with standard-dose clopidogrel (139 [1·6%] vs 99 [1·1%]; 1·41, 1·09-1·83, p=0·009) and did not differ between high-dose and low-dose aspirin (128 [1·5%] vs 110 [1·3%]; 1·18, 0·92-1·53, p=0·20). INTERPRETATION: FUNDING: Sanofi-Aventis and Bristol-Myers Squibb.
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Authors | Shamir R Mehta, Jean-Francois Tanguay, John W Eikelboom, Sanjit S Jolly, Campbell D Joyner, Christopher B Granger, David P Faxon, Hans-Jurgen Rupprecht, Andrzej Budaj, Alvaro Avezum, Petr Widimsky, Philippe Gabriel Steg, Jean-Pierre Bassand, Gilles Montalescot, Carlos Macaya, Giuseppe Di Pasquale, Kari Niemela, Andrew E Ajani, Harvey D White, Susan Chrolavicius, Peggy Gao, Keith A A Fox, Salim Yusuf, CURRENT-OASIS 7 trial investigators |
Journal | Lancet (London, England)
(Lancet)
Vol. 376
Issue 9748
Pg. 1233-43
(Oct 09 2010)
ISSN: 1474-547X [Electronic] England |
PMID | 20817281
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2010 Elsevier Ltd. All rights reserved. |
Chemical References |
- Platelet Aggregation Inhibitors
- Clopidogrel
- Ticlopidine
- Aspirin
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Topics |
- Acute Coronary Syndrome
(therapy)
- Aged
- Angioplasty, Balloon, Coronary
(adverse effects)
- Aspirin
(administration & dosage, adverse effects)
- Cardiovascular Diseases
(etiology, prevention & control)
- Clopidogrel
- Female
- Humans
- Male
- Platelet Aggregation Inhibitors
(administration & dosage, adverse effects)
- Stents
(adverse effects)
- Thrombosis
(etiology, prevention & control)
- Ticlopidine
(administration & dosage, adverse effects, analogs & derivatives)
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