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Antiplatelet Agent

Risk-Prevention Therapies for Coronary Artery Disease (ARTCAP Trial)

Phase 4
Recruiting
Led By Dinesh Kalra, MD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

"This trial aims to see how a medication affects the heart of patients at risk for coronary heart disease. Patients aged 18-80 with or without heart disease symptoms will be selected based on their risk factors

Who is the study for?
This trial is for adults aged 18-80 at intermediate/high risk for heart disease, with certain types of non-obstructive plaque in their heart's arteries. Excluded are those with severe heart conditions, recent hospitalizations for heart failure, life expectancy under a year, organ transplant recipients or candidates, pregnancy or planning to conceive during the study period, known drug intolerances (like statins/aspirin), very poor kidney function, inability to receive contrast for scans and uncontrolled psychiatric illness.
What is being tested?
The ART-CAP trial tests if medications like Nexlizet, Aspirin tablet, LEQVIO, Statin, Jardiance,Vascepa and Colchicine can change blood vessels in the heart. Participants will undergo CT scans to assess changes in coronary artery narrowing as part of evaluating these aggressive risk-prevention therapies.
What are the potential side effects?
Potential side effects from the drugs may include muscle pain or weakness (statins), bleeding risks (aspirin), kidney issues (Jardiance), gastrointestinal symptoms (Colchicine) among others. Each medication has its own set of possible side effects that participants will be monitored for.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Characterization of plaque to evaluate for high-risk features - low CT attenuation
Characterization of plaque to evaluate for high-risk features - napkin-ring sign
Characterization of plaque to evaluate for high-risk features - positive remodeling
+4 more
Secondary study objectives
Buffy coat for chromatin immunoprecipitation (ChIP)
Change in Lipoprotein (a)
Change in high sensitivity C-creative protein (HS-CRP) levels
+10 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, ColchicineExperimental Treatment7 Interventions
An AT group: FDA-approved drugs will be used to reduce cholesterol and cardiovascular risk.
Group II: SOC: Statin ± Aspirin (per ACC guidelines)Active Control2 Interventions
The SOC group: participant receive routine care as per cardiologist. Study doctor will prescribe medications that they choose themselves.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Statin
2011
Completed Phase 4
~110100
Aspirin tablet
2022
Completed Phase 4
~260
Vascepa
2017
Completed Phase 4
~80
Colchicine
2014
Completed Phase 4
~18130
Jardiance
2015
N/A
~8150

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
345 Previous Clinical Trials
77,215 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
33 Patients Enrolled for Coronary Artery Disease
Dinesh Kalra, MDPrincipal InvestigatorUniversity of Louisville School of Medicine
1 Previous Clinical Trials
700 Total Patients Enrolled
~133 spots leftby Jan 2029
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