Ranolazine for Incomplete Vessel Revascularization post-PCI
Research type
Research Study
Full 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
IRAS ID
90218
Contact name
David Hildick-Smith
Sponsor organisation
Gilead Sciences Inc
Eudract number
2011-002507-15
Clinicaltrials.gov Identifier
Research summary
Coronary artery disease is the narrowing or blockage of the coronary arteries. This can cause chest pain called angina. Therapeutic procedures used for the treatment of narrowed coronary arteries include revascularization technologies such as Percutaneous Coronary Intervention (PCI). Despite the widespread use and continued evolution of revascularization technologies and optimal medical therapy for coronary artery disease, the incidence of angina after percutaneous coronary intervention (PCI) remains high (up to 1/3 of patients will suffer from post PCI angina one year after follow up), contributing to repeat revascularization procedures and hospitalizations, as well as increased outpatient testing and resource utilization. In one of previous clinical research studies (PROSPECT) severe or unstable angina accounted for approximately 75% of all major adverse cardiovascular events (MACE), while cardiovascular death and myocardial infarction accounted for the remaining 25%. , Recurrent anginal and/or ischemic symptoms after PCI, which may be due to residual untreated disease, progressive atherosclerosis, or recurrent restenosis at previous treatment sites, often lead to repeat hospitalisations and repeat revascularisations, as well as further outpatient evaluations, making this a therapeutic target worthy of medical intervention. Previous clinical trial experience with ranolazine has demonstrated it to be a safe and effective agent for the management of chronic stable angina as either monotherapy or in combination with other commonly used antianginal medications. This study aims to determine whether ranolazine taken together with standard medicines, may be an effective agent for the reduction of ischemic events post-PCI and subsequently may reduce the incidence of post-PCI hospitalisation due to angina and ischemia, reduce hospitalisation for repeat PCI, and potentially reduce the incidence of other major adverse cardiovascular events (MACE) such as myocardial infarction and sudden cardiac death. Approximately 2600 patients will be enrolled in 200 centres worldwide. The participants will be randomised in ratio 1:1 to receive either 1000 mg ranolazine or matching placebo. The study will consist of 3 periods: pre-treatment (screening and baseline evaluation), treatment period (taking the assigned medicine for 1 year), and post-treatment period (follow up). Participants will be required to visit the study centre up to 6 times during both the pre-treatment and treatment periods.
REC name
London - Dulwich Research Ethics Committee
REC reference
12/LO/0062
Date of REC Opinion
1 Feb 2012
REC opinion
Favourable Opinion