Acronym: The Clopidogrel and aspirin optimal dose Usage to Reduce Recurrent Events - seventh Organization to Assess Strategies in Ischemic Syndromes
Purpose: To evaluate the use of clopidogrel (Plavix) loading at 600 mg or 300 mg in patients with acute coronary syndromes as well as aspirin loading with high or low dose.
Format: Double-blind, multicenter, randomized control trial
Treatment Group: Clopidogrel 600 mg followed by 150 mg daily for 6 days then 75 mg daily AND/OR high dose aspirin 300-325 mg daily
Control Group: Clopidogrel 300 mg followed by 75 mg daily AND/OR low dose aspirin 75-100 mg daily
Number of Patients: 25,086
Age > 18
Non-ST elevation myocardial infarction or ST elevation myocardial infarction
Ischemic ECG changes
Elevated cardiac biomarkers
Increased risk of bleeding
Known allergic reaction to clopidogrel or aspirin
Follow-up: 30 days
Primary Endpoint: Cardiovascular death, MI or stroke
Composite of cardiovascular death, MI or stroke
Evaluated clopidogrel 600 mg load in patients with acute coronary syndromes. The only benefit to using higher clopidogrel loading dose was seen in patients undergoing percutaneous coronary intervention (PCI) which included a decrease in the primary outcome of cardiovascular death, MI or stroke. There was a significant reduction in stent thrombosis, but an increased risk of intracranial and fatal bleeding.
Mehta SR, et al. N Engl J Med. 2010;doi:10.1056/NEJMoa0909475.
Mehta SR, et al. Lancet. 2010;doi:10.1016/S0140-6736(10)61088-4.