The Safety of Transdermal Nicotine Immediately Following an Acute Coronary Syndrome
Status:
Suspended
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
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.