Randomized, Multinational, Double-Blind Study, Comparing a High Loading Dose Regimen of Clopidogrel versus Standard Dose in Patients with Unstable Angina or Myocardial Infarction Managed With an Early Invasive Strategy
To evaluate whether a higher dosage of clopidogrel with aspirin (two doses) will decrease the risk of ischemic complications (cardiac death, stroke, and myocardial infarction) after a percutaneous coronary intervention. The CURRENT-OASIS 7 (Clopidogrel optimal loading dose Usage to Reduce Recurrent EveNTs-Organization to Assess Strategies in Ischemic Syndromes) study will be the first adequately powered randomized trial to determine the efficacy and safety of higher dose compared with lower dose ASA and clopidogrel for treatment of ACS. The results of this large factorial study will have direct relevance to clinical practice worldwide.
Randomized, double-blind, dose comparison, factorial assignment, efficacy study.
Primary endpoint: first occurrence of cardiovascular death, myocardial infarction and stroke up to 30 days. Secondary endpoints: major bleeding and the net efficacy to safety balance of death, MI, stroke, or severe bleeding at 30 days. All primary and secondary endpoints are adjudicated.
Andrea Robinson, Barbara Jedrzejowski