Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05850091
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Rosuvastatin — DRUG
    Pharmacotherapy for reduction in LDL cholesterol level
  • Colchicine — DRUG
    Pharmacotherapy for inflammation inhibition
  • Placebo — DRUG
    Capsule with sugar pill that mimics active study drugs

Study Details

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.

Key Dates

Start date
Dec 7, 2023
Status verified
May 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Change in total non-calcified plaque volume from baseline to one year [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Akl C Fahed, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Massachusetts General Hospital· Boston, MA

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