Phase 3 Trial Underway to Test Ranolazine in Patients After PCI

Issue: January/February 2012

Gilead and the Cardiovascular Research Foundation are spearheading the phase 3 RIVER-PCI trial to examine the effects of ranolazine on MACE in patients with a history of chronic angina who have incomplete revascularization following PCI, according to a press release.

“Despite the widespread use of revascularization technologies and optimal medical therapy for CAD, the incidence of angina after PCI remains high, contributing to repeat procedures and hospitalizations, as well as increased outpatient testing and resource utilization,” Gregg W. Stone, MD, professor of medicine and director of cardiovascular research and education at Columbia University Medical Center, New York, who will chair the study, said in the release. “In analyses of registries and clinical trial data, recurrent anginal or ischemic symptoms after PCI have been found to be more common in patients with incomplete revascularization, suggesting that new therapeutic strategies are needed.”

The randomized, double blind, placebo-controlled RIVER-PCI trial will enroll 2,600 patients with a history of chronic angina who undergo angiography and PCI either for ACS or elective non-ACS indication from 200 centers in the United States, Canada, Europe and Israel. Ranolazine (Ranexa, Gilead), which has currently not been determined to be safe or efficacious as a treatment to reduce MACE in patients who have undergone PCI, will be administered twice daily and matched 1:1 against placebo in addition to standard medical therapy, and patients will be followed for no less than 1 year after randomization.

According to the release, the primary endpoint of RIVER-PCI will be the incidence of MACE, defined as the composite of CV death, MI or hospitalization for ischemia or angina. The study will continue until at least 721 post-randomization MACE have been observed.

Disclosure: Dr. Stone reports no relevant financial disclosures.