Enrolment for ACCOAST was suspended by an independent data monitoring committee on November 16, 2012 when a planned interim analysis showed that pre-treatment with prasugrel was associated with an increased risk of major and life-threatening bleeding, although no increased rate of mortality.
The phase 3, randomized, double blind, event-driven study conducted in 171 centers and 19 countries in Europe, Canada, Israel and Turkey, randomized 4033 patients to either pre-treatment with prasugrel or placebo at the time of NTSE-ACS diagnosis (n=2037) followed by prasugrel given selectively after the coronary angiogram to patients with a confirmed indication for PCI (n=1996). Patients in both arms also received aspirin and standard of care.
Patients were to be scheduled to undergo coronary angiography/PCI within 48 hours from randomization.
Patients In the pre-treatment arm received a 30-mg loading dose (LD) of prasugrel at the time of randomization and, if PCI was indicated, an additional 30-mg at the time of PCI, while patients in the no pre-treatment arm got a placebo dose at randomization, and, if PCI was indicated, a 60-mg LD of prasugrel at the time of PCI.
Ultimately, PCI was performed in 68.7% of subjects, while in the 7 days post-randomization coronary artery bypass surgery (CABG) was chosen for 6.2% and medical management for 25.1%.
For the primary endpoint, a composite of cardiovascular death, myocardial infarction, stroke, urgent revascularization or GPIIb/IIIa bailout at 7 and 30 days post-randomization, there was no significant difference between the pre-treatment and no pre-treatment groups (10.0% vs 9.8%, p = 0.812, and 10.8 vs 10.8, p = 0.976, respectively).
However, the rate of all major bleeding, according to Thrombolysis in Myocardial Infarction (TIMI) criteria was almost double in the pre-treatment g
|Contact: ESC Press Office|
European Society of Cardiology