DEFINE-DM trial, protocol no. AMCCV2023-03, ver 1.5_Jun 13, 2024
Research type
Research Study
Full title
Diabetes-Centered Evaluation of Revascularization Strategy of Functional and Imaging-CombiNEd State-of-the-Art Percutaneous Coronary Intervention or Coronary-Artery Bypass Grafting in Patients with Diabetes Mellitus and Multivessel Coronary Artery Disease
IRAS ID
356274
Contact name
Sandeep Basavarajaiah
Contact email
Sponsor organisation
Asan Medical Center
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 31 days
Research summary
This study aims to compare outcomes of imaging-and physiology-guided state-of-the-art PCI to CABG in patients with diabetes and multivessel CAD with LAD involvement, thereby contributing valuable insights to the treatment of this patient population.
Key Study Details
1. Study Objective: The primary objective of the DEFINE-DM trial is to demonstrate that imaging or physiology-guided state-of-the-art PCI with contemporary DES on the background of GDMT would be non-inferior to standard CABG in patients with diabetes and multivessel CAD with LAD involvement who are equivalently eligible for PCI and CABG with respect to the primary endpoint of MACCE (defined as a composite outcome of death from any cause, MI, or stroke) at 2 years.2. Number of Participants: 1,360 subjects
3. Study Duration: Six years: 4 years of enrollment and 2 years of clinical follow-up for assessment of primary and secondary endpoints.
4. Study Design: An investigator-initiated, multicenter, international, randomized, controlled trial including at least 50 participating sites worldwide.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
25/WM/0230
Date of REC Opinion
3 Feb 2026
REC opinion
Further Information Favourable Opinion