CURRENT-OASIS 7 Trial

Trial Details:

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

Inclusion Criteria: 

• Age > 18
• Non-ST elevation myocardial infarction or ST elevation myocardial infarction
• Ischemic ECG changes
• Elevated cardiac biomarkers

Exclusion Criteria:

• Increased risk of bleeding
• Active bleeding
• Known allergic reaction to clopidogrel or aspirin

Follow-up: 30 days

Primary Endpoint: Cardiovascular death, MI or stroke

Secondary Endpoint: 

• Composite of cardiovascular death, MI or stroke
• All-cause mortality

Summary:

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.

Original Publications:

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.