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
- Conditions
- Interventions
- 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)
| Facility | City | Province |
|---|---|---|
| Royal Alexandra Hospital | Edmonton | Alberta |
| University of Alberta Hospital | Edmonton | Alberta |
| New Brunswick Heart Centre | Saint John | New Brunswick |
| Hamilton Health Sciences | Hamilton | Ontario |
| Hamilton Health Sciences, General Site | Hamilton | Ontario |
| Scarborough Cardiology Research Associates | Scarborough Village | Ontario |
| Saint Michael's Hospital | Toronto | Ontario |
| University Health Network | Toronto | Ontario |
| Centre Hospitalier de l'Universite de Montreal (CHUM) | Montreal | Quebec |
| Hôpital du Sacré-Coeur de Montréal | Montreal | Quebec |
| Montreal Heart Institute | Montreal | Quebec |
| Institut Universitaire de Cardiologie et de Pneumologie de Québec | Québec | Quebec |
| Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01442038