The Oasis study group has presented initial results of the CURRENT-OASIS 7 clinical trial at the European Society of Cardiology congress in Barcelona. CURRENT-OASIS 7 clinical trial evaluated different dosing regimens of PLAVIX plus aspirin in a broad range of acute coronary syndrome (ACS) patients.
The study was designed to assess the efficacy and safety of an intensified clopidogrel regimen versus the approved PLAVIX dosage for patients managed with an early invasive strategy with an intent for percutaneous coronary intervention (PCI).
Reportedly, the primary end-point for the entire study population regimens did not reach statistical significance.
For clinically relevant subgroups that were pre-specified for preliminary analyses, such as the PCI subgroup (70% of the trial population), potentially medically relevant differences in patient outcomes were observed.
The subgroup, analysis showed an improvement in outcome for patients taking the higher dose regimen (600mg loading / 150mg for days 2-7 / 75mg days 8-30) over the standard dose regimen (300mg loading / 75mg for days 2-30), as shown by the reduction of the same composite end-point of cardiovascular death, myocardial infarction and stroke by 15%.
In addition, analysis showed an important 42% relative risk reduction in definite stent thrombosis with the higher dose regimen of clopidogrel over the standard loading dose.
The primary safety end-point was assessed by the stringent bleeding definition of OASIS and while a significant increase in the primary safety end-point of major bleeding with the high-dose compared to the standard-dose PLAVIX regimen was observed in the overall trial population.
Jean-Pierre Lehner, CMO of sanofi-aventis, said: “An artery opening procedure with stent placement exposes a patient to an increased risk of stent occlusion and subsequent heart attack. CURRENT-OASIS 7 provides important new information about a high-dose regimen of PLAVIX in ACS patients planned for PCI. We are pleased to contribute to furthering the understanding of patient care during the acute phase of coronary intervention.”