CURRENT-OASIS-7 TRIAL

Problem ACS
Format Double-blinded multi-center RCT
Treatment Low/high dose clopidogrel & aspirin
Control -
Population 25086 patients
Inclusion criteria 18 years of age or older
Non ST-segment elevation OR ST-segment elevation myocardial infarction
Either
-electrocardiographic changes compatible with ischemia
-elevated levels of cardiac biomarkers

An additional requirement was coronary angiographic assessment, with a plan to perform PCI as early as possible but no later than 72 hours after randomisation.
Exclusion criteria Increased risk of bleeding or active bleeding and a known allergy to clopidogrel or aspirin
Follow-up 30 days
Primary endpoint Cardiovascular death, myocardial infarction, or stroke at 30 days
Secondary endpoint(s) Composite of death from cardiovascular causes, myocardial infarction, stroke, or recurrent ischemia; the individual components of the primary outcome; and death from any cause
Details .
Brief summary: 600mg clopidogrel superior in PCI patients only; No benefits of 300mg aspirin over 75mg after loading
PAPER: Dose comparisons of clopidogrel and aspirin in acute coronary syndromes.
Date 2 Sep 2010
Journal N Engl J Med. 2010 Sep 2;363(10):930-42.
Information ALL patients:
-600mg (loading) & 150mg vs. 300mg (loading) & 75mg Clopidogrel
--No significant difference in primary outcome of cardiovascular death, MI or stroke
--Increased risk of major bleeding
--No significant difference in intracranial, CABG-related or fatal bleeding.

-300mg (laoding) & 75-100mg vs. 300mg (loading) & 300-325mg Aspirin
--No significant difference in primary outcome of cardiovascular death, MI or stroke
--No significant difference in bleeding
PAPER: Double-dose versus standard-dose clopidogrel and high-dose versus low-dose aspirin in individuals undergoing percutaneous coronary intervention for acute coronary syndromes (CURRENT-OASIS 7)
Date 9 Oct 2010
Journal Lancet. 2010 Oct 9;376(9748):1233-43.
Information Prespecified analysis is of the 17,263 individuals who underwent PCI
-600mg (loading) & 150mg vs. 300mg (loading) & 75mg Clopidogrel
--Significant reduction in primary outcome of cardiovascular death, MI or stroke
--Significant reduction in stent thrombosis
--Increased risk of major bleeding
--No increase in intracranial/fatal bleeding

-300mg (laoding) & 75-100mg vs. 300mg (loading) & 300-325mg Aspirin
--No significant difference in primary outcome of cardiovascular death, MI or stroke
--No difference in bleeding