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NCT05850091 · ClinicalTrials.gov registry record · Phase 4
Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine
A Phase 4 study of Coronary Artery Disease, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT05850091: Recruiting Phase 4 study of Coronary Artery Disease, sponsored by Massachusetts General Hospital.
NCT05850091 is a Phase 4 study of Coronary Artery Disease that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 200 participants, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05850091, a Phase 4 study of Coronary Artery Disease, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The primary outcome of this study is the change in total non-calcified plaque volume between the two groups from baseline to one year. This outcome will be measured using coronary computed tomography angiography (CCTA) and reported in cubic millimeters (mm³). The comparison of the changes in non-calcified plaque volume will help assess the effectiveness of the intervention on plaque progression and composition.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Colchicine
- DRUG Rosuvastatin
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-12-07 |
| Est. Completion | 2027-05-01 |
| Phase | Phase 4 |
What NCT05850091 shows while recruiting
NCT05850091 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05850091 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05850091 about?
NCT05850091 is a clinical study titled "Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine". 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.
What is the current status of trial NCT05850091?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 2023-12-07. Estimated completion is 2027-05-01.
What conditions does trial NCT05850091 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT05850091?
The interventions under investigation include: Placebo (DRUG), Colchicine (DRUG), Rosuvastatin (DRUG).
Who is sponsoring clinical trial NCT05850091?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05850091 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Coronary Artery Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05850091's enrollment target sits among peer trials
200 117th of 219 higher than 100 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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