NCT05850091Active, not recruitingPhase 4
Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 6 Apr 2023
- Start date
- 7 Dec 2023
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT05850091
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- From 7 Dec 2023 to the primary completion date, 1 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Participant with a history of cardiovascular disease, defined by a diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease
- Patient with history of an allergic reaction or significant sensitivity to iodinated contrast, colchicine, or statins
Lab values
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
Related publications
- Polygenic Risk Based Detection and Treatment of Subclinical Coronary Atherosclerosis in the PROACT Clinical Trials.J Am Coll Cardiol · 2026 · PMID 41706060
This page is information, not medical advice. Discuss any trial with your doctor.