4-way crossover study of BMS-914392 in Atrial Fibrillation v1

• Research type

  Research Study

• Full title

  Randomized, Double-Blind, Placebo-Controlled, 4-Way Crossover Study to Evaluate the Safety, Tolerability and Effect on Atrial Fibrillation Burden of BMS-914392 in Patients with Paroxysmal Atrial Fibrillation and Permanent Pacemaker.

• IRAS ID

  25469

• Contact name

  Neil Sulke

• Sponsor organisation

  Bristol Myers Squibb International Corporation

• Eudract number

  2010-022947-39

• ISRCTN Number

  N/A

• Research summary

  TITLE: A trial to test the safety and effectiveness of a potential new drug to treat patients with pacemakers who suffer from recurring, irregular heart beats (Atrial Fibrillation) (CV203010). The heart has four chambers. The upper two chambers of the heart are called atria. In a healthy heart the atria beat in a regular rhythm to make blood flow through the heart and around the body. In some people their atria spontaneously contract out of their normal rhythm. These irregular heart beats are called arrhythmias. The most common type of heart arrhythmia is called Atrial Fibrillation (AF). AF affects approximately 1-2% of the population. AF prevents normal blood flow through the heart. Left untreated, AF can cause further damage to the heart. AF can also cause complications to pre-existing diseases. The irregular beats can also create blood clots in the heart which can travel to the brain, causing strokes and possible death. BMS-914392 is a tablet taken orally. The drug specifically targets the atria of the heart. In the atria it works to regulate the heart contractions. It helps the heart to beat in a constant rhythm. This is a potential treatment to prevent AF arrhythmias. Previously, BMS-914392 has been studied in the USA and Japan in healthy volunteers. In this study two different dose levels, each given either once-a-day or three times-a-day, will be tested. BMS-914392 will also be compared to placebo. This study will be run in specialised NHS research units. Patients who have a pacemaker and suffer from recurring AF may be eligible for this study. Approximately 20 patients who meet the study inclusion criteria will be given BMS-914392. The study is designed to determine if BMS-914392 reduces the number of AF episodes and if it extends the period of time between AF episodes.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  10/H1107/77

• Date of REC Opinion

  18 Mar 2011

• REC opinion

  Further Information Favourable Opinion