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

CompletedPhase 3NCT01442038
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

Brief summary (from the registry)

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.

Study details

Official title
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
Sponsor
Gilead Sciences
Start date
2011-10
Primary completion
2015-02
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Austria, Belgium, Canada, Czechia, France, Germany, Israel, Italy, Netherlands, Poland, Russia, Spain, Sweden, United Kingdom, United States
Total sites listed
218

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Written informed consent 2. Males and females aged 18 years and older 3. History of chronic angina defined as at least 2 episodes of anginal pain or discomfort in the chest, jaw, shoulder, back, neck, or arm that is precipitated by exertion or emotional stress, and relieved by rest or sublingual nitroglycerin, which occurred on at least 2 separate days and at least 14 days prior to PCI (in the case of staged PCI procedures, at least 14 days prior to the first PCI in the series). Participants may or may not have additional angina episodes within the 14 days prior to their first PCI in the series, as well as any time prior to Randomization. 4. PCI for any indication (ACS or non-ACS). For the purposes of stratification at randomization, ACS will be defined as hospitalization for anginal pain or discomfort within the previous 24 hours to their hospitalization with any one (or more) of the following criteria: i. Elevated troponin or creatinine kinase-MB (CK-MB) consistent with myocardial infarction (MI), as reported by local laboratory and measured prior to index PCI ii. Electrocardiographic changes (including transient changes) comprising new or presumably new ST segment depression ≥ 0.1 mV (≥ 1 mm), or ST segment elevation ≥ 0.1 mV (≥ 1 mm) in at least 2 contiguous leads, or new or presumably new Left Bundle Branch Block 5. Randomization within 14 days post-PCI. In the case of staged PCI procedures, randomization has to occur within 14 days of the last PCI in the series. Participants may be randomized starting on the day of PCI and anytime during the following 14 days. PCI is defined as an attempt to cross the lesion with a wire with the intention of performing revascularization. 6. Post-PCI (post the last PCI for staged procedures) evidence of incomplete revascularization defined as the presence of one or more visually estimated ≥ 50% stenoses in one or more coronary arteries with reference vessel diameter of at least 2.0 mm, whether in the target vessel or in a non-target vessel regardless of the presence or absence of coronary collaterals. In the case of a participant post-coronary artery bypass grafting (CABG), incomplete revascularization is defined as the presence of one or more visually estimated ≥ 50% stenoses in an unbypassed epicardial vessel with a reference diameter of ≥ 2.0 mm, or one or more visually estimated ≥ 50% stenoses in a bypass graft supplying an otherwise unrevascularized myocardial territory. 7. Clinically stabl…

Canadian sites (13)

FacilityCityProvince
Royal Alexandra HospitalEdmontonAlberta
University of Alberta HospitalEdmontonAlberta
New Brunswick Heart CentreSaint JohnNew Brunswick
Hamilton Health SciencesHamiltonOntario
Hamilton Health Sciences, General SiteHamiltonOntario
Scarborough Cardiology Research AssociatesScarborough VillageOntario
Saint Michael's HospitalTorontoOntario
University Health NetworkTorontoOntario
Centre Hospitalier de l'Universite de Montreal (CHUM)MontrealQuebec
Hôpital du Sacré-Coeur de MontréalMontrealQuebec
Montreal Heart InstituteMontrealQuebec
Institut Universitaire de Cardiologie et de Pneumologie de QuébecQuébecQuebec
Centre Hospitalier Universitaire de SherbrookeSherbrookeQuebec
Canadian sites for NCT01442038EdmontonSaint JohnHamiltonScarborough VillageTorontoMontrealQuébecSherbrooke
Canadian sites for NCT01442038. 8 mapped locations with coordinates in the registry. Schematic plot, not to scale.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01442038