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OASIS 7 - CURRENT

Official Title

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

Status

Completed

Overview

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.

Study Design

Randomized, double-blind, dose comparison, factorial assignment, efficacy study.

Primary Endpoint

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.

Number of Patients

25000

Number of Sites

640

Number of Countries

40

Study Period

2005–2009

Principal Investigator

Shamir Mehta

Program Manager

Susan Chrolavicius

Research Coordinator

Andrea Robinson, Barbara Jedrzejowski

Key Publications

  • Mehta SR et al. 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): a randomised factorial trial. The Lancet Published Online September 2, 2010 DOI:10.1016/S0140-6736(10)61088-4.
  • Mehta SR, Bassand JP, Chrolavicius S, Diaz R, Fox KA, Granger CB, Jolly S, Rupprecht HJ, Widimsky P, Yusuf S; CURRENT-OASIS 7 Steering Committee. Design and rationale of CURRENT-OASIS 7: a randomized, 2 x 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. Am Heart J. 2008;156(6):1080-1088.