SOURCE: Baim Institute for Clinical Research

November 14, 2016 08:00 ET

Baim Institute for Clinical Research: Enrollment Completed for RE-DUAL PCI™ Study of 2,700 Atrial Fibrillation Patients

BOSTON, MA--(Marketwired - November 14, 2016) -

  • Over 2,700 atrial fibrillation (AF) patients undergoing a percutaneous coronary intervention (PCI) with stenting randomized in Boehringer Ingelheim sponsored RE-DUAL PCI™ trial 1,2
  • First PCI study to evaluate the safety of a dual versus triple antithrombotic regimen using non-vitamin K antagonist oral anticoagulant (NOAC) dosages already approved for AF-stroke prevention
  • The results will support physicians in choosing an optimal antithrombotic regimen for AF patients who require a PCI

The Baim Institute has announced that patient enrollment into the international Phase IIIb RE-DUAL PCI™ study is complete. The study evaluates the safety and efficacy of dabigatran etexilate in atrial fibrillation (AF) patients undergoing a percutaneous coronary intervention (PCI) with stent placement. This is the first time that two dosages of a non-vitamin K antagonist oral anticoagulant (NOAC) already approved for stroke prevention in AF are evaluated in a dual versus triple antithrombotic regimen after PCI.

"Up to 30% of AF patients may have coronary artery disease and require PCI with stenting, yet to date only limited data exists on the use of the NOACs during this procedure," said Dr. Christopher Cannon, RE-DUAL PCI™ Lead Investigator and Executive Director, Cardiometabolic Trials, Baim Institute for Clinical Research, who is a cardiologist at Brigham and Women's Hospital in Boston and a Professor of Medicine, Harvard Medical School. "The RE-DUAL PCI™ study will provide new insights into antithrombotic treatment approaches in AF patients requiring PCI.

"We expect the results to be highly clinically relevant for practicing physicians who treat patients such as these in routine care, as the study uses the two dabigatran doses already internationally approved for stroke risk reduction in AF," said Dr. Cannon.

The results of the RE-DUAL PCI study are expected during the second half of 2017. The study is sponsored by Boehringer-Ingelheim.

References:

  1. Clinicaltrials.gov. Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI). https://clinicaltrials.gov/ct2/show/NCT02164864 Last accessed November 2016.
  2. Cannon C.P. et al. Design and Rationale of the RE-DUAL PCI Trial: A Prospective, Randomized, Phase 3b Study Comparing the Safety and Efficacy of Dual Antithrombotic Therapy With Dabigatran Etexilate Versus Warfarin Triple Therapy in Patients With Nonvalvular Atrial Fibrillation Who Have Undergone Percutaneous Coronary Intervention With Stenting. Clin Cardiol. 2016;39(10):555-564. Available at http://onlinelibrary.wiley.com/doi/10.1002/clc.22572/full

About The Baim Institute for Clinical Research
The Baim Institute for Clinical Research (formerly known as Harvard Clinical Research Institute) is a leading, not-for-profit academic research organization that delivers insight, innovation and leadership in today's dynamic research environment. The Baim Institute collaborates with some of the world's most highly respected researchers from renowned institutions to help advance health and quality of life around the world.

Since 1993, we have worked on over 450 clinical trials in North America, Europe and Asia. The Baim Institute is based in Boston. More information is at www.BaimInstitute.org.