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Genotype-Guided Smoking Cessation Therapy for Coronary Artery Disease

N/A
Waitlist Available
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult presenting to Barnes hospital cardiac catheterization laboratory with coronary artery disease or admitted to Barnes hospital within 24 hours of a type 1 myocardial infarction (heart attack)
Be older than 18 years old
Must not have
Unable to provide informed consent
Unable to answer questions (e.g. intubated)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after enrollment
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if using genetic information to guide smoking cessation treatment can help patients with coronary artery disease quit smoking more effectively. Patients will receive either nicotine replacement therapy or counseling based on their genetic test results.

Who is the study for?
This trial is for adults with coronary artery disease undergoing cardiac catheterization or who have had a heart attack, and are active smokers. They must be able to consent, not incarcerated, stable post-heart attack without life-threatening complications, and women of child-bearing age should not be pregnant or breastfeeding.
What is being tested?
The study tests if nicotine patches and genotype-guided therapy can help patients quit smoking more effectively than standard treatments. Patients' genetic profiles determine their treatment plan in this randomized study.
What are the potential side effects?
Nicotine patch use may cause skin irritation, dizziness, racing heartbeat, sleep problems or unusual dreams. Counseling has no physical side effects but discussing smoking cessation can sometimes cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was admitted to Barnes hospital for a heart attack or have coronary artery disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to understand and give consent for treatment.
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I am currently unable to communicate verbally.
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I am pregnant or breastfeeding.
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I have had serious complications from a heart attack.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Smoking Cessation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Genotype-guided (GG homozygotes)Experimental Treatment2 Interventions
CHRNA5 rs16969968 genotype will be determined. Genotype-guided therapy will be given (GG homozygotes will be given smoking cessation counseling)
Group II: Genotype-guided (A allele carriers)Experimental Treatment2 Interventions
CHRNA5 rs16969968 genotype will be determined. Genotype-guided therapy will be given (A allele carriers will be given pharmacologic therapy (nicotine replacement therapy --NRT; nicotine patch used according to FDA labelling).)
Group III: Standard (non-genotype guided) - NRTActive Control1 Intervention
1/2 of patients in this arm will be given nicotine replacement therapy (NRT; nicotine patch used according to FDA labeling) but this will NOT be based on the patient's genotype. Note that both nicotine replacement therapy and counseling are accepted treatments for smoking cessation in patients with coronary artery disease.
Group IV: Standard (non-genotype guided)- counselingActive Control1 Intervention
1/2 of patients in this arm will be given smoking cessation counseling but this will NOT be based on the patient's genotype. Note that both nicotine replacement therapy and counseling are accepted treatments for smoking cessation in patients with coronary artery disease.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine patch
2015
Completed Phase 4
~6130
Smoking cessation counseling
2011
Completed Phase 4
~10150

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Nicotine Replacement Therapy (NRT) works by delivering nicotine to the body without the harmful chemicals found in tobacco smoke, thereby reducing withdrawal symptoms and cravings. This is crucial for Coronary Artery Disease (CAD) patients because smoking is a significant risk factor for CAD, and quitting smoking can lead to substantial improvements in cardiovascular health. Moreover, tailoring NRT based on a patient's genetic profile can enhance its effectiveness, leading to higher quit rates and better overall management of CAD.
Pharmacological Smoking Cessation Therapies in Older Adults: A Review of the Evidence.

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,984 Previous Clinical Trials
2,291,620 Total Patients Enrolled
19 Trials studying Coronary Artery Disease
5,360 Patients Enrolled for Coronary Artery Disease

Media Library

genotype-guided therapy Clinical Trial Eligibility Overview. Trial Name: NCT03383224 — N/A
Coronary Artery Disease Research Study Groups: Genotype-guided (GG homozygotes), Genotype-guided (A allele carriers), Standard (non-genotype guided) - NRT, Standard (non-genotype guided)- counseling
Coronary Artery Disease Clinical Trial 2023: genotype-guided therapy Highlights & Side Effects. Trial Name: NCT03383224 — N/A
genotype-guided therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03383224 — N/A
~7 spots leftby Jul 2025