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Behavioural Intervention
Aggressive Smoking Cessation for Acute Coronary Syndrome (ASAP Trial)
Phase 3
Recruiting
Research Sponsored by Sir Mortimer B. Davis - Jewish General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Unstable angina with significant coronary artery disease, defined by ischemic symptoms, ECG changes indicative of ischemia, and at least one lesion ≥ 50% on angiogram performed during the current hospitalization
Able to understand and provide informed consent in English or French
Must not have
NYHA or Killip Class III or IV at the time of randomization
Planned use of cannabis (smoked) or other tobacco products (smoked or other) during the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 2, 4, 8, 12, 18, and 52 weeks
Awards & highlights
Summary
This trialwill assess if aggressive smoking cessation therapy given in-hospital to smokers with ACS helps them quit for good.
Who is the study for?
The ASAP trial is for adults over 18 who smoke at least 10 cigarettes a day, are hospitalized with Acute Coronary Syndrome (ACS), and want to quit smoking. They must understand English or French, be able to buy e-cigarettes if in the combination therapy group, and commit to a year-long follow-up. Excluded are those with recent use of varenicline or e-cigarettes, serious reactions to these products, severe heart failure, pregnancy, certain medications for quitting smoking or psychiatric disorders.
What is being tested?
This study tests two methods to help people stop smoking after being hospitalized for ACS: one combines a drug called varenicline with nicotine e-cigarettes and counseling; the other uses just varenicline plus counseling. Participants will be randomly assigned to either method for 12 weeks and then checked on for up to a year.
What are the potential side effects?
Possible side effects include nausea, sleep problems, mood changes from varenicline; throat irritation from e-cigarettes; both can potentially worsen pre-existing heart conditions due to nicotine's effects on the cardiovascular system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe heart disease with symptoms and changes seen in tests during this hospital stay.
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I can understand and consent in English or French.
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I was hospitalized for a heart attack with specific heart enzyme levels and ECG changes.
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I have smoked at least one cigarette a day for the past year.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My heart condition severely limits my daily activities.
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I plan to use cannabis or tobacco products during the study.
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My kidney function is severely impaired.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 2, 4, 8, 12, 18, and 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 2, 4, 8, 12, 18, and 52 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with 7-day point prevalence smoking abstinence
Secondary study objectives
Change in daily cigarette consumption
Frequency of Adverse Events (AEs)
Frequency of Serious Adverse Events (SAEs)
+7 moreOther study objectives
Change in daily cigarette consumption at all other weeks
Number of participants with point prevalent abstinence or ≥50% reduction in daily cigarette consumption at all other weeks
Number of patients averaging ≥1 pill of varenicline/day
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Varenicline Plus CounselingExperimental Treatment1 Intervention
All patients will begin varenicline in-hospital upon randomization. For the first 3 days, patients will take a 0.5 mg tablet once a day. They will then take a 0.5 mg tablet twice a day for the following 4 days, and one 1 mg tablet twice a day from day 8 onward for the remainder of the 12-week treatment. Use will be monitored via self-report for telephone follow-ups and return of all unused tablets at the end of the treatment period. Should a patient experience severe side effects (such as headache, nausea, vomiting, dizziness, dyspepsia, fatigue, insomnia, abnormal dreams, constipation, or flatulence) on day 8 onward, the varenicline dose should be reduced from 1 mg twice daily to 0.5 mg twice daily prior to study medication discontinuation.
Group II: Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling)Active Control1 Intervention
Patients in the combination therapy arm will be supplied funds and instructions for the purchase of e-cigarettes and cartridges/pods upon hospital discharge and at the week 4 and 12 clinic visits. As with standard NRTs such as the gum, inhaler, and lozenge, the investigators expect smokers will self-regulate administration according to their withdrawal symptoms. Use will be monitored via self-report for telephone follow-ups. At clinic visits, patients will be asked to bring their e-cigarettes, used and unused cartridges/pods, and purchasing receipts. Patients will be advised regarding the signs and symptoms of nicotine toxicity and of an allergic reaction.
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Who is running the clinical trial?
Sir Mortimer B. Davis - Jewish General HospitalLead Sponsor
58 Previous Clinical Trials
20,418 Total Patients Enrolled
1 Trials studying Acute Coronary Syndrome
30 Patients Enrolled for Acute Coronary Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a mental health condition that is not currently well-managed.I can start varenicline in the hospital and use a nicotine e-cigarette after my heart procedure.You have used nicotine or non-nicotine e-cigarettes in the 30 days before being admitted to the hospital for acute coronary syndrome.I have severe heart disease with symptoms and changes seen in tests during this hospital stay.I am willing and able to buy specific e-cigarettes if needed for the study.My heart condition severely limits my daily activities.You have used illegal drugs in the past year.I can understand and consent in English or French.I have used medication to quit smoking in the last 30 days.I was hospitalized for a heart attack with specific heart enzyme levels and ECG changes.I have smoked at least one cigarette a day for the past year.You want to quit smoking and have a high level of motivation according to a scale called the Motivation To Stop Scale.I have used varenicline or e-cigarettes for 2 weeks or more in the last year.I am 18 years old or older.I plan to use cannabis or tobacco products during the study.I haven't taken any anti-craving medication in the last 30 days.You had a bad reaction to varenicline or e-cigarettes in the past.My kidney function is severely impaired.
Research Study Groups:
This trial has the following groups:- Group 1: Varenicline Plus Counseling
- Group 2: Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling)
Awards:
This trial has 4 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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.
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