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Antiplatelet Agent

AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, Colchicine for Heart Attack (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

ARTCAP 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.Check my eligibility

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.See study design

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.

ARTCAP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Buffy coat for chromatin immunoprecipitation (ChIP)

Change in Lipoprotein (a)

Change in high sensitivity C-creative protein (HS-CRP) levels

+10 more

ARTCAP 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

Jardiance

2015

N/A

~8150

Statin

2011

Completed Phase 4

~110100

Vascepa

2017

Completed Phase 4

~80

Aspirin tablet

2022

Completed Phase 4

~260

Colchicine

2020

Completed Phase 4

~12140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor

339 Previous Clinical Trials

76,480 Total Patients Enrolled

Dinesh Kalra, MDPrincipal InvestigatorUniversity of Louisville School of Medicine

1 Previous Clinical Trials

700 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals meet the eligibility criteria to take part in this medical study?

"Recruitment is ongoing for 200 individuals aged between 18 and 80 with coronary artery disease. Essential eligibility requirements include the presence of non-obstructive atherosclerotic plaque in a major heart vessel measuring more than 2 mm across, with stenosis falling within the range of either 0-39% or 40-69% alongside an FFR-CT value exceeding >0.8."

Answered by AI

How many individuals are currently enrolled as participants in this clinical trial?

"Yes, information on clinicaltrials.gov states that this study is actively seeking participants. The trial was first listed on March 1st, 2024 and last revised on March 18th, 2024. It aims to enroll 200 individuals at a single site."

Answered by AI

Is the enrollment phase of this medical study currently ongoing?

"Affirmative. Data from clinicaltrials.gov indicates that this trial is actively seeking participants. The study was first listed on March 1, 2024, and last revised on March 18, 2024. Recruitment aims to reach a total of 200 individuals at one location."

Answered by AI

Are individuals older than 60 years eligible to participate in this study?

"Eligible participants for this research study must be at least 18 years old but not exceed 79 years of age."

Answered by AI

What are the specific goals and objectives of this research study?

"The key objective of this clinical study, to be evaluated over an 18-month period starting from a baseline assessment, is the quantification of pericoronary fat attenuation. Supplementary endpoints encompass analyzing buffy coat for chromatin immunoprecipitation (ChIP) through blood sampling to identify genomic binding sites of proteins related to coronary plaque formation. Secondary measurements will include variations in interleukin-6 (IL-6) concentrations measured in picograms per milliliter and changes in high sensitivity Troponin (HS-Tn) levels recorded in nanograms per milliliter via blood samples."

Answered by AI

Have the medications AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance and Colchicine received approval from the FDA?

"Given that this trial is classified as Phase 4 and involves established treatments, our team rates the safety of AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, Colchicine at the highest level of 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)

Dinesh Kalra, MD 2024. "Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06280976.

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