RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Rosuvastatin 20 Mg Oral Tablet for Coronary Artery Disease Risk Factors Multiple

Q: Is NCT07232069 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT07232069?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT07232069?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

Heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States. This clinical trial will test if screening and early treatment of mild heart disease works.

Official registry: https://clinicaltrials.gov/study/NCT07232069 · Duke University · enrollment listed as 1,500

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Rosuvastatin 20 Mg Oral Tablet, Colchicine 0.5 MG Oral Tablet Once Daily, or Placebo. The registry lists allocation as randomized. Heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States.

They plan to enroll about 1,500 people at 23 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis

Interventions: Rosuvastatin 20 Mg Oral Tablet, Colchicine 0.5 MG Oral Tablet Once Daily, Placebo

Primary outcome (registry wording): Non-calcified plaque volume (NCPV) on CCTA at 2 years, adjusted for baseline NCPV.

Who it is for (from inclusion criteria)

Ages 30 Years to 60 Years
Women aged 40-60 years; Men aged 30-50 years
Use of highly effective contraception by females with reproductive potential
CAC score 1-99 in the screening study or entry through the known plaque pathway (with mild CAC or CAC\<100 if known; elevated CAC on baseline CCTA is not exclusionary in the known plaque arm)
Diagnostic baseline CCTA with NCPV ≥10 mm3 as assessed by the central core lab

Who the registry excludes

Clinical diagnosis of ASCVD including coronary artery disease (CAD), peripheral arterial disease (PAD) or cerebrovascular disease (CeVD)
Current symptoms thought to be from CAD
PREVENT ASCVD 10-year risk ≥5% (if known)
Diabetes Mellitus (DM) as defined by any of the following: DM diagnosis in the medical record or HbA1C of 6.5% or greater. (if known)
LDL-C ≥190mg/dL (most recent, if known)
Severe liver disease or untreated Hepatitis C infection (if known)
Pregnancy, lactation or intending to become pregnant during the study period of 2 years

Public study contact (from the registry)

Rachel Olson, Project Manager

919-309-5544

rachel.e.olson@duke.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

23 listed

University of Alabama at Birmingham — Birmingham, Alabama (recruiting)
Cardiology Associates — Mobile, Alabama (recruiting)
University of California, Los Angeles — Los Angeles, California (recruiting)
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center — Los Angeles, California (recruiting)
Wellstar Kennestone Hospital — Hiram, Georgia (recruiting)
University of Chicago — Chicago, Illinois (recruiting)
Johns Hopkins University — Baltimore, Maryland (not_yet_recruiting)
Massachusetts General Hospital Brigham — Boston, Massachusetts (recruiting)
Essentia Health — Duluth, Minnesota (recruiting)
Northern Westchester Hospital — Mount Kisco, New York (not_yet_recruiting)
New York University Langone — New York, New York (recruiting)
Weill Cornell Medicine — New York, New York (recruiting)

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FAQ about this NCT record

Is NCT07232069 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07232069?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07232069?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary