Detecting and treating early coronary artery disease using genetic risk factors
Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine
This study is testing if high-intensity statin therapy, low-dose colchicine, or a combination of both can help people with early signs of heart disease and a high genetic risk for it.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05850091 on ClinicalTrials.gov |
What this trial studies
This double-blind randomized controlled trial aims to evaluate the effects of high-intensity statin therapy, low-dose colchicine, and their combination on the progression of coronary atherosclerosis in individuals identified as having a high polygenic risk for coronary artery disease. The study will involve 200 participants aged 40 to 75 with subclinical atherosclerosis, who will be randomly assigned to receive either a placebo, rosuvastatin, colchicine, or both. The primary outcome will be the change in total non-calcified plaque volume measured by coronary computed tomography angiography over one year, alongside various secondary outcomes related to plaque imaging and biomarkers.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 40 to 75 with a high polygenic risk score for coronary artery disease and subclinical atherosclerosis.
Not a fit: Patients with a history of cardiovascular disease or significant liver or kidney issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing coronary artery disease in high-risk individuals.
How similar studies have performed: Other studies have shown promise in using genetic risk factors to guide treatment strategies, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Participant with a history of cardiovascular disease, defined by a diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease * Participant with a history of Liver disease (cirrhosis, active hepatitis, or severe hepatic disease) or any of the following recent lab results and determined to be non-transient: alanine aminotransferase greater than 3 times the upper limit of normal or total bilirubin greater than 2 times the upper limit of normal (unless due to Gilbert syndrome) * Participant with estimated glomerular filtration rate \<60 mL/min/1.73 m2 or creatinine greater than 2 times the upper limit of normal * Patient with history of an allergic reaction or significant sensitivity to iodinated contrast, colchicine, or statins * Patient currently taking LDL cholesterol lowering or anti- inflammatory medications including colchicine * Participants requiring regular drugs known to be potent CY2P inhibitors (eg. ketoconazole, clarithromycin) * Female patient who is pregnant, or breast-feeding or is considering becoming pregnant during the study * Participant with BMI ≥ 40 kg/m2 * Participant unable to provide informed consent * Participant unable to hold breath for 10 seconds
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Roukoz Abou-Karam, MD
- Email: proact@mgb.org
- Phone: (617)-643-4842
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.