NCT01442038

Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Ranolazine on Major Adverse Cardiovascular Events in Subjects With a History of Chronic Angina Who Undergo Percutaneous Coronary Intervention With Incomplete Revascularization

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,651 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy of ranolazine as compared with placebo when used as part of standard medical therapy in chronic angina subjects with incomplete revascularization post-percutaneous coronary intervention (PCI; formerly known as angioplasty with stent) on the composite of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization.

Conditions

• Coronary Artery Disease
• Angina Pectoris

Interventions

Type	Name	Description
DRUG	Ranolazine	Subjects will receive ranolazine 500 milligrams (mg) twice daily for 7 days, followed by 1000 mg administered orally twice daily for the duration of the study. Subjects receiving a moderate CYP3A4 inhibitor will receive ranolazine 500 mg or placebo administered orally twice a day for the duration of the concomitant therapy.
DRUG	Placebo	Subjects will receive one tablet of matching placebo twice daily for 7 days, followed by two tablets of matching placebo twice daily for the duration of the study. Subjects receiving a moderate CYP3A4 inhibitor will receive ranolazine 500 mg or placebo administered orally twice a day for the duration of the concomitant therapy.

Timeline

• Start date: 2011-10-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2011-09-28
• Last updated: 2016-07-15
• Results posted: 2016-07-15

Locations

218 sites across 15 countries: United States, Austria, Belgium, Canada, Czechia, France, Germany, Israel, Italy, Netherlands, Poland, Russia, Spain, Sweden, United Kingdom