The Safety of Transdermal Nicotine Immediately Following an Acute Coronary Syndrome

• Status: Suspended
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Continuing to smoke after having a heart attack greatly increases the risk of death and cardiac illness. The nicotine patch is a commonly used pharmacotherapy for smoking cessation and has great potential to help heart attack patients quit smoking. However, due to safety concerns, physicians are often hesitant to prescribe the nicotine patch to patients who have just suffered a heart attack. The STADIA pilot study will assess the feasibility of a large-scale clinical trial investigating safety and efficacy outcomes associated with the nicotine patch immediately following a heart attack. Eligible subjects will be randomized within 48 hours of suffering a heart attack to wear a transdermal nicotine patch on either day 1 or day 2 of the study period. The nicotine patch will deliver nicotine to the patient over the period of 24 hours. Patients will be advised to discuss smoking cessation strategies with their treating physician and subsequent care will be left to the discretion of this physician. The duration of ischemia (loss of blood flow in the heart), patient adherence, incidence of arrhythmia (disorder of the heart rate or rhythm), heart rate, and blood pressure within the two groups will be used to evaluate the safety of transdermal nicotine use immediately after a heart attack.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
• Collaborator: Canadian Tobacco Control Research Initiative
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Current smoker, ≥ 10 cigarettes per day, on average, for the past year

• Suffered an enzyme-positive ACS (Troponin T, Troponin I, or CK-MD) and planned hospitalization of ≥ 48 hours

• Motivated to quit smoking

Exclusion Criteria:

• Current use of any medical therapy for smoking cessation

• History of alcohol or controlled substance abuse

• History of severe dermatitis

• Current diagnosis of unstable psychiatric illness requiring medication

• Suffered an ACS as a complication of a hospitalization for a different condition (i.e. postoperatively)

• Pregnancy or lactation

• Likely to be unavailable for follow-up

• Unable to read and understand English or French