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CURRENT-OASIS 7
Clopidogrel optimal loading dose Usage to Reduce Recurrent Events – Organisation to Assess Strategies in Ischaemic Syndromes 7
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Author(s) |
(a) Mehta SR, Bassand J-P, Chrolavicius S, Diaz R, Fox KAA, Granger CB, Jolly S, Rupprecht H-J, Widimsky P, Yusuf S
(b) CURRENT-OASIS 7 investigators
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Title(s) |
(a) Design and rationale of CURRENT-OASIS 7: a randomized, 2 × 2 factorial trial evaluating optimal dosing strategies for clopidogrel and aspirin in patients with ST and non-ST-elevation acute coronary syndromes managed with an early invasive strategy
(b) Dose comparisons of clopidogrel and aspirin in acute coronary syndromes
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Reference(s) |
(a) Am Heart J 2008;156:1080–8.e1
(b) N Engl J Med 2010;363:930–42
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Disease |
Acute coronary syndromes |
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Purpose |
To evaluate the efficacy and safety of a standard versus high dose of clopidogrel and a low versus high dose of ASA in patients with acute coronary syndromes undergoing PCI |
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Study design |
Randomised, open (ASA), double-blind (clopidogrel), parallel-group, 2 × 2 factorial |
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Follow-up |
30 days |
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Patients |
25,086 patients, mean age 61 years, with ST- or non-ST-segment elevation acute coronary syndromes, undergoing PCI |
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Treatment regimen |
Clopidogrel, 300 mg loading dose, followed by 75 mg/day (standard dose), or 600 mg loading dose, followed by 150 mg/day on days 2–7, then 75 mg/day on days 8–30 (high dose), plus ASA, ≥ 300 mg loading dose, followed by 75–100 mg/day (low dose) or 300–325 mg/day (high dose) |
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Concomitant therapy |
Antithrombin therapy and GP IIb/IIIa inhibitors at the discretion of the physician |
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Results |
The primary outcome of cardiovascular death, MI or stroke occurred in 4.4% of patients in the standard-dose clopidogrel group vs 4.2% in the high-dose clopidogrel group (hazard ratio 0.94, 95% CI 0.83–1.06; p = 0.30). A primary outcome event occurred in 4.4% of patients in the low-dose ASA group vs 4.2% in the high-dose ASA group (hazard ratio 0.97, 95% CI 0.86–1.09; p = 0.61). Among patients in the low-dose ASA, there were no significant differences between the standard-dose and high-dose clopidogrel groups in the occurrence of primary outcome events (4.2% vs 4.5%, hazard ratio 1.07, 95% CI, 0.90–1.26; p = 0.46). Among patients in the high-dose ASA, the primary outcome occurred in 4.6% of patients in the standard-dose clopidogrel group vs 3.8% in the high-dose clopidogrel group (hazard ratio 0.82, 95% CI 0.69–0.98; p = 0.03). Major bleeding occurred in 2.0% of patients in the standard-dose clopidogrel group vs 2.5% in the high-dose clopidogrel group (hazard ratio 1.24, 95% CI 1.05–1.46; p = 0.01). Major bleeding events were not significantly different between the ASA groups |
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