Coronary Artery DiseaseNCT03383224
PRISM-GENOMICS-Smoking Cessation for Patients With Coronary Artery Disease Undergoing Cardiac Catheterization or Having a Heart Attack at Barnes Hospital in St. Louis Mo
A study testing genotype-guided therapy, Nicotine patch and Smoking cessation counseling in people with Coronary Artery Disease and Smoking Cessation, run by Washington University School of Medicine at 1 site in United States.
Trial summary
It has previously been shown that patients with coronary artery disease may have a harder time quitting smoking if they have a specific genetic profile and that these individuals have a better chance at quitting if they receive nicotine replacement therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Smoking Cessation
- What is being tested?
- genotype-guided therapy, Nicotine patch and Smoking cessation counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2015to 21 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- active smoker at time of presentation to Barnes Hospital
- participating in PRISM-GENOMICS observational study
Who cannot join
- Unable to provide informed consent
- Unable to answer questions (e.g. intubated)
- Incarcerated
- Complications of myocardial infarction (such as shock, hemodynamic instability, life- threatening infection, etc)
- Women of child-bearing age with positive pregnancy test or who is breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Angina and Genotype-Guided Smoking Cessation In PRISM-GENOMICS
It has previously been shown that patients with coronary artery disease may have a harder time quitting smoking if they have a specific genetic profile and that these individuals have a better chance at quitting if they receive nicotine replacement therapy. The investigators hypothesize that determining which individuals with coronary artery disease should receive nicotine replacement therapy based on their genotype may improve the number of individuals who are able to quit smoking.This study randomizes treatment to that determined by the patient's genotype compared to standard, non-genotype-guided, treatment.
Read the detailed description
In this study, the investigators propose to show the feasibility of incorporating genotype-guided therapy into post-MI smoking cessation therapy and/or smoking cessation therapy in patients with coronary artery disease (CAD) using the CHRNA5 rs16969968 variant as the pilot case. The investigators propose to genotype ½ of PRISM-GENOMICs patients who are active smokers within 48 hours of admission and to guide their smoking cessation therapy based on CHRNA5 rs16969968 genotype (A allele carriers will be given pharmacologic therapy and GG homozygotes will be given counseling). The investigators will use the other ½ as controls. The participants will be followed and the investigators will test whether the genotype-guided group has better rates of smoking cessation compared to the control group. This pilot study will lay the foundation for personalized, genotype-guided, post-MI therapy and/or therapy in patients with CAD.
- Conditions
- Coronary Artery Disease, Smoking Cessation
- Being tested
- genotype-guided therapy, Nicotine patch, Smoking cessation counseling
- Keywords
- smoking cessation treatment
- Medical subject headings
- Coronary Artery Disease, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genotype-guided therapyOther
treatment based on patient's CHRNA5 rs16969968 genotype
Nicotine patchDrug
Smoking cessation counselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Genotype-guided (A allele carriers) | Experimental | 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).) Receives: Other: genotype-guided therapy; Drug: Nicotine patch |
| Genotype-guided (GG homozygotes) | Experimental | CHRNA5 rs16969968 genotype will be determined. Genotype-guided therapy will be given (GG homozygotes will be given smoking cessation counseling) Receives: Other: genotype-guided therapy; Behavioral: Smoking cessation counseling |
| Standard (non-genotype guided) - NRT | Active comparator | 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. Receives: Drug: Nicotine patch |
| Standard (non-genotype guided)- counseling | Active comparator | 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. Receives: Behavioral: Smoking cessation counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cessation
Number of participants no longer smoking as assessed by telephone-administered questionnaire
Measured: 1 month after enrollment
Secondary outcomes (2)
Smoking Cessation
Number of participants no longer smoking as assessed by telephone-administered questionnaire
Measured: 6 months after enrollment
Smoking Cessation
Number of participants no longer smoking as assessed by telephone-administered questionnaire
Measured: 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start21 Jul 2015
- Primary completion21 Jul 2025 (estimated)
- Study completion21 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized to genotype-guided therapy or standard of care
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Cresci, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383224
- Sponsor's protocol ID
- 201412097
- Status last verified
- Oct 2021
- First submitted
- 12 Dec 2017
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angina and Genotype-Guided Smoking Cessation In PRISM-GENOMICS
- ClinicalTrials.gov ID
- NCT03383224
- Acronym / sponsor ID
- 201412097
- Conditions
- Coronary Artery Disease, Smoking Cessation
- Keywords
- smoking cessation treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 21 Jul 2015 (actual)
- Primary completion
- 21 Jul 2025 (estimated)
- Study completion
- 21 Jul 2025 (estimated)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It has previously been shown that patients with coronary artery disease may have a harder time quitting smoking if they have a specific genetic profile and that these individuals have a better chance at quitting if they receive nicotine replacement therapy. The investigators hypothesize that determining which individuals with coronary artery disease should receive nicotine replacement therapy based on their genotype may improve the number of individuals who are able to quit smoking.This study randomizes treatment to that determined by the patient's genotype compared to standard, non-genotype-guided, treatment.
Detailed description
In this study, the investigators propose to show the feasibility of incorporating genotype-guided therapy into post-MI smoking cessation therapy and/or smoking cessation therapy in patients with coronary artery disease (CAD) using the CHRNA5 rs16969968 variant as the pilot case. The investigators propose to genotype ½ of PRISM-GENOMICs patients who are active smokers within 48 hours of admission and to guide their smoking cessation therapy based on CHRNA5 rs16969968 genotype (A allele carriers will be given pharmacologic therapy and GG homozygotes will be given counseling). The investigators will use the other ½ as controls. The participants will be followed and the investigators will test whether the genotype-guided group has better rates of smoking cessation compared to the control group. This pilot study will lay the foundation for personalized, genotype-guided, post-MI therapy and/or therapy in patients with CAD.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized to genotype-guided therapy or standard of care
| Arm | Type | Receives |
|---|---|---|
| Genotype-guided (A allele carriers) | Experimental | Other: genotype-guided therapy, Drug: Nicotine patchCHRNA5 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).) |
| Genotype-guided (GG homozygotes) | Experimental | Other: genotype-guided therapy, Behavioral: Smoking cessation counselingCHRNA5 rs16969968 genotype will be determined. Genotype-guided therapy will be given (GG homozygotes will be given smoking cessation counseling) |
| Standard (non-genotype guided) - NRT | Active comparator | Drug: Nicotine patch1/2 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. |
| Standard (non-genotype guided)- counseling | Active comparator | Behavioral: Smoking cessation counseling1/2 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
- active smoker at time of presentation to Barnes Hospital
- participating in PRISM-GENOMICS observational study
Key exclusion criteria (5 listed)
- Unable to provide informed consent
- Unable to answer questions (e.g. intubated)
- Incarcerated
- Complications of myocardial infarction (such as shock, hemodynamic instability, life- threatening infection, etc)
- Women of child-bearing age with positive pregnancy test or who is breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genotype-guided therapytreatment based on patient's CHRNA5 rs16969968 genotype | Other | Genotype-guided (A allele carriers), Genotype-guided (GG homozygotes) |
| Nicotine patch | Drug | Genotype-guided (A allele carriers), Standard (non-genotype guided) - NRT |
| Smoking cessation counseling | Behavioural | Genotype-guided (GG homozygotes), Standard (non-genotype guided)- counseling |
Primary outcome
Smoking Cessation
Time frame: 1 month after enrollment
Number of participants no longer smoking as assessed by telephone-administered questionnaire
2 secondary outcomes
Smoking Cessation
Time frame: 6 months after enrollment
Smoking Cessation
Time frame: 12 months after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing genotype-guided therapy, Nicotine patch and Smoking cessation counseling in people with Coronary Artery Disease and Smoking Cessation, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Cessation (time frame: 1 month after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.