Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The goal of this double-blind randomized controlled trial is to determine how treatment with high intensity statin, low-dose colchicine, and their combination modulates progression and composition of coronary atherosclerosis in individuals with high polygenic risk for coronary artery disease.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:
• Males and females between 40 and 75 years of age capable and willing to provide informed consent
• Participant has high CAD PRS as defined on a clinical test
• Participant with subclinical atherosclerosis defined as plaque visible on CCTA and causing \<70% luminal stenosis
Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Roukoz Abou-Karam, MD
proact@mgb.org
(617)-643-4842
Time Frame
Start Date: 2023-12-07
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 200
Treatments
Placebo_comparator: Group A
Participants will receive placebo daily
Active_comparator: Group B
Participants will receive rosuvastatin 20mg daily and placebo daily
Active_comparator: Group C
Participants will receive colchicine 0.6mg daily and placebo daily
Active_comparator: Group D
Participants will receive rosuvastatin 20mg daily and colchicine 0.6mg daily
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)