Coronary Artery Disease Risk Factors Multiple study: Rosuvastatin vs Colchicine
Official title PRE-EMPT: Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis
ClinicalTrials.gov ID: NCT07232069
What this study is testing
What is Rosuvastatin 20 Mg Oral Tablet?
This is an investigational cholesterol-lowering medicine being studied to see if it helps reduce or stabilize plaque in heart arteries. It is designed to lower cholesterol levels in the blood.
Also referred to as Crestor.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see whether finding and treating early plaque in people who are otherwise low risk can slow or stop heart disease progression.
- Who it's for
- Adults with low 10‑year heart‑risk scores but who have heart‑disease risk factors such as high cholesterol or smoking.
- What's involved
- Participants first get scans to look for plaque. Those with plaque may be randomly given either a placebo or a mix of two pills (a cholesterol drug and an anti‑inflammatory drug). Everyone receives heart‑healthy advice. Visits include scans, phone check‑ins, and at‑home blood draws.
- Time commitment
- The study lasts about two years, with an initial screening visit, several phone follow‑ups, and in‑person visits at 12 and 24 months for scans and blood tests.
- Phase 3: a large, late-stage study
- Time commitment: about 2 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 60
You may be able to join if
- Women aged 40-60 years; Men aged 30-50 years
- Willing and able to provide informed consent and comply with study procedures
- Smart phone user
- 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
You likely can't join if
- 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)
- HIV (if known)
See the full eligibility criteria
- Women aged 40-60 years; Men aged 30-50 years
- Willing and able to provide informed consent and comply with study procedures
- Smart phone user
- 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
- 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)
- HIV (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
- eGFR \<45mL/min/1.73m2 (if known)
- AST or ALT \>1.5x the upper limit of normal (if known)
- BMI\>40kg/m2 or unable to have a CCTA scan for any reason
- Allergy to iodinated intravenous contrast or other contraindication to CCTA
- Current or previous use of lipid lowering therapy or colchicine
- Known allergic reactions or sensitivity to the study intervention(s), including known intolerance or contraindication(s) to statin or colchicine, or long-term use of medications that are contraindicated with colchicine...
- Systemic cancer undergoing active treatment
- PREVENT ASCVD 10-year risk ≥5%
- eGFR \<45 ml/min/1.73m2 per baseline labs, (2021 CKD-EPI equation will be used if multiple options are available)
- Hemoglobin A1c ≥6.5% per baseline labs
- LDL-C ≥190mg/dL per baseline labs
- Severe proximal coronary artery stenosis as determined by the central core lab (≥50% left main or ≥70% proximal major coronary artery stenosis)
- Known contraindication to follow-up CCTA (e.g., new IV contrast allergy discovered during the baseline CCTA)
- Individuals who are excluded based on any of these factors will be notified as to the reason for exclusion and encouraged to follow-up locally to address this medical issue with their treating physician.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Mobile, Alabama, United States
- Los Angeles, California, United States
- Hiram, Georgia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Duluth, Minnesota, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Pittsburgh, Pennsylvania, United States
- Charleston, South Carolina, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
- Marshfield, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Mobile, Alabama, United States; Los Angeles, California, United States; Hiram, Georgia, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States and 9 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.