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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

No Placebo-Only Group

Pivotal Trial

Approved for 5 Other Conditions

All Individual Drugs Already Approved

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 2, 4, 8, 12, 18, and 52 weeks for reporting.

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 more

Other 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 more

Awards & Highlights

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.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial 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.

0 / 8Eligibility criteria met