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HMG-CoA Reductase Inhibitor
Statin + Colchicine for Coronary Artery Disease (PROACT 2 Trial)
Phase 4
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant has high CAD PRS as defined on a clinical test
Participant with subclinical atherosclerosis defined as plaque visible on CCTA and causing <70% luminal stenosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
PROACT 2 Trial Summary
This trial tests if combining statins with a low dose of colchicine could reduce risk of coronary artery disease in high-risk individuals.
Who is the study for?
This trial is for men and women aged 40-75 with a high genetic risk for coronary artery disease, who have early-stage plaque buildup in their arteries seen on a heart scan but no severe blockage. They must not have liver or severe kidney disease, allergies to the drugs being tested, be taking certain other medications, be pregnant or breastfeeding, extremely overweight, or have a history of heart problems.Check my eligibility
What is being tested?
The study tests if high-dose statins (Rosuvastatin), low-dose Colchicine, or their combination can slow down or change the makeup of early-stage artery plaque in people at high genetic risk for heart disease. Participants are randomly assigned to get one of these treatments or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
Possible side effects include muscle pain and weakness from Rosuvastatin; diarrhea, nausea and potential blood disorders from Colchicine; plus general risks like allergic reactions. The exact side effects will vary by individual.
PROACT 2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My clinical test shows I have a high risk for coronary artery disease.
Select...
I have early-stage artery disease visible on a heart scan, but it's not severely blocking my arteries.
Select...
I have a high genetic risk for heart artery disease.
Select...
I have early-stage artery blockage visible on a heart scan.
PROACT 2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in total non-calcified plaque volume from baseline to one year
Secondary outcome measures
Change in C-reactive protein (CRP) from baseline to one year
Change in Interleukin-6 and Interleukin-1 beta (IL-1ß) from baseline to one year
Change in calcium score from baseline to one year
+6 morePROACT 2 Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: Group DActive Control2 Interventions
Participants will receive rosuvastatin 20mg daily and colchicine 0.6mg daily
Group II: Group BActive Control2 Interventions
Participants will receive rosuvastatin 20mg daily and placebo daily
Group III: Group CActive Control2 Interventions
Participants will receive colchicine 0.6mg daily and placebo daily
Group IV: Group APlacebo Group1 Intervention
Participants will receive placebo daily
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,941 Previous Clinical Trials
13,200,469 Total Patients Enrolled
22 Trials studying Coronary Artery Disease
10,349 Patients Enrolled for Coronary Artery Disease
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,847 Previous Clinical Trials
47,818,326 Total Patients Enrolled
165 Trials studying Coronary Artery Disease
268,832 Patients Enrolled for Coronary Artery Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am pregnant, breastfeeding, or might become pregnant during the study.You have had a strong allergic reaction to iodinated contrast, colchicine, or statins in the past.I cannot hold my breath for 10 seconds.I am between 40 and 75 years old and can give my consent.My kidney function is reduced, with low filtration rates or high creatinine.I have a history of heart or blood vessel disease.I am unable to understand and give consent for treatment.I am not taking strong CY2P inhibitors like ketoconazole.My BMI is 40 or higher.I am currently on medication to lower my LDL cholesterol or for inflammation.My clinical test shows I have a high risk for coronary artery disease.I have early-stage artery disease visible on a heart scan, but it's not severely blocking my arteries.I have liver disease or my recent liver tests are much higher than normal.I have a high genetic risk for heart artery disease.I have early-stage artery blockage visible on a heart scan.
Research Study Groups:
This trial has the following groups:- Group 1: Group A
- Group 2: Group D
- Group 3: Group B
- Group 4: Group C
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment open to elderly individuals?
"Patients between the ages of 40 and 75 are eligible to partake in this medical trial."
Answered by AI
Does Intervention pose any risks to participants?
"By the standards of our team at Power, Intervention has been deemed safe enough to be given a 3 rating as it is in its fourth phase - indicating that this treatment has already gained approval."
Answered by AI
Would I have access to participate in this trial?
"To partake in this research, volunteers must have previously been diagnosed with coronary artery disease and be within the age range of 40 to 75. A maximum of 150 participants are eligible for inclusion."
Answered by AI
Are individuals eligible to join this experiment presently?
"Contrary to what is displayed on clinicaltrials.gov, this specific trial is no longer enrolling patients; the original posting was made on July 1st 2023 and edited most recently on April 28th 2023. However, there are currently 670 other medical studies that require participants for their experiments."
Answered by AI
Who else is applying?
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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