Effect of Ranolazine on Myocardial Perfusion - Amend 3

• Research type

  Research Study

• Full title

  A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Cross-over Trial to Evaluate the Effects of Ranolazine on Myocardial Perfusion Assessed by Serial Quantitative Exercise SPECT Imaging

• IRAS ID

  85490

• Contact name

  Roxy Senior

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2011-001516-54

• Clinicaltrials.gov Identifier

  NCT01221272

• Research summary

  This is a clinical research study involving an experimental drug named ranolazine, which is currently approved in the United States and the EU for the treatment of chronic angina (chest pain), to find out whether heart muscle is getting enough blood. If a person has coronary artery disease (CAD; a narrowing of the blood vessels to the heart that decreases blood flow) they may have decreased blood flow to the heart muscle. CAD is a leading cause of death. This study will use single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) to see if ranolazine can improve blood flow to the heart muscle. SPECT MPI is a method widely used to look at whether there are areas of the heart that are not getting enough blood flow. It involves taking some special pictures, also called scans, of the heart after injection of a nuclear tracer (technetium-99m), a drug that helps the physician visualise the heart. These pictures will be taken after the heart has been working harder, or has been ‘stressed’, which, in this study, will require the participant to walk on a treadmill. The purpose of this study is to evaluate by SPECT MPI if ranolazine can improve blood flow to the heart muscle (myocardial ‘perfusion) when taken prior to exercise. This is a double-blind, placebo-controlled study, which means that the person and the Study Doctor will not know which study drug (ranolazine or placebo) the participant will be taking. A placebo is a tablet containing material with no medicinal effect but looks like the active study drug tablet. “ Active” means that the tablet contains ranolazine with potential medicinal effect on myocardial perfusion. Ranolazine and matching placebo tablets will be supplied by Gilead Sciences, Inc., which is also the Sponsor of this study.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  11/LO/1438

• Date of REC Opinion

  24 Nov 2011

• REC opinion

  Further Information Favourable Opinion