Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
30 – 60
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
1,500 (estimated)
Sponsor
Duke University · Other
Who this trial is looking for
This trial is looking for people at low risk of heart disease to check for early signs of cholesterol build-up in heart arteries. If selected, participants may take part in a two-year treatment study testing medications to help manage this condition.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman aged 40-60 years or a man aged 30-50 years.
I can provide informed consent and follow study procedures.
I use a smartphone.
I use effective birth control if I could become pregnant.
I have a Coronary Artery Calcium score between 1 and 99.
I have a baseline CCTA result with a specific measure of plaque.
You may not be able to join if
I have been diagnosed with coronary artery disease or other heart diseases.
I currently have symptoms related to heart disease.
I have a 10-year heart disease risk of 5% or more.
I have diabetes or a high blood sugar level.
I have a high cholesterol level.
I have HIV.
I am pregnant, breastfeeding, or plan to become pregnant.
I have severe kidney problems.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
PRE-EMPT will screen individuals at low 10-year risk of heart disease with heart disease risk factors to identify those who already have early cholesterol build up, also called "pla…
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.
PRE-EMPT will screen individuals at low 10-year risk of heart disease with heart disease risk factors to identify those who already have early cholesterol build up, also called "plaque", in their heart arteries. It consists of two phases:
1. A Screening Study - Participants will be assessed for plaque by one or both of these scans.
* Coronary Artery Calcium (CAC) Scan: A CT scan that looks for calcium or plaque in heart arteries.
* Coronary CT Angiography (CCTA) Scan: A CT scan that uses contrast dye to create detailed 3D pictures of heart arteries to look for plaque.
2. A Treatment Trial (approximately 1,500 participants) - Based on the results of the CCTA, participants may be randomized into a two-year trial to test medications aimed at reducing or stabilizing plaque. Participants will have a 1 in 4 chance of receiving only placebo, and a 3 in 4 chance of receiving at least one active medication. Participants will take two pills once a day-either both active medications, one active and one placebo, or both placebos.
* Rosuvastatin 20 mg: a cholesterol-lowering medicine
* Colchicine 0.5 mg: a medication that lowers inflammation
Everyone in the trial will be given information and advice on heart-healthy diet and lifestyle.
Participants will have up to two in-person visits for the screening study, then phone visits for the Treatment Trial at the beginning, 3 months, 12 months and 24 months when they will also have an in-person visit for a CCTA Scan. Participants will have blood drawn using an at-home collection device mailed to their home at the beginning, 3 months, and end of the study.
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Eligibility Criteria
Inclusion Criteria:
1. Women aged 40-60 years; Men aged 30-50 years
2. Willing and able to provide informed consent and comply with study procedures
3. Smart phone user
4. Use of highly effective contraception by females with reproductive potential.
5. CAC score 1-99 in the screening study or entry…
Inclusion Criteria:
1. Women aged 40-60 years; Men aged 30-50 years
2. Willing and able to provide informed consent and comply with study procedures
3. Smart phone user
4. Use of highly effective contraception by females with reproductive potential.
5. 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)
6. Diagnostic baseline CCTA with NCPV ≥10 mm3 as assessed by the central core lab
Exclusion Criteria:
1. Clinical diagnosis of ASCVD including coronary artery disease (CAD), peripheral arterial disease (PAD) or cerebrovascular disease (CeVD)
2. Current symptoms thought to be from CAD
3. PREVENT ASCVD 10-year risk ≥5% (if known)
4. 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)
5. LDL-C ≥190mg/dL (most recent, if known)
6. HIV (if known)
7. Severe liver disease or untreated Hepatitis C infection (if known)
8. Pregnancy, lactation or intending to become pregnant during the study period of 2 years
9. eGFR \<45mL/min/1.73m2 (if known)
10. AST or ALT \>1.5x the upper limit of normal (if known)
11. BMI\>40kg/m2 or unable to have a CCTA scan for any reason
12. Allergy to iodinated intravenous contrast or other contraindication to CCTA
13. Current or previous use of lipid lowering therapy or colchicine
14. 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 or rosuvastatin.
15. Systemic cancer undergoing active treatment
16. PREVENT ASCVD 10-year risk ≥5%
17. eGFR \<45 ml/min/1.73m2 per baseline labs, (2021 CKD-EPI equation will be used if multiple options are available)
18. Hemoglobin A1c ≥6.5% per baseline labs
19. LDL-C ≥190mg/dL per baseline labs
20. Severe proximal coronary artery stenosis as determined by the central core lab (≥50% left main or ≥70% proximal major coronary artery stenosis)
21. Known contraindication to follow-up CCTA (e.g., new IV contrast allergy discovered during the baseline CCTA)
22. 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.
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