The Safety of Transdermal Nicotine Immediately Following an Acute Coronary Syndrome (STADIA)

This study has suspended participant recruitment.

(Difficulties with enrollment.)

Sponsor:

Collaborator:

Canadian Tobacco Control Research Initiative

Information provided by:

Sir Mortimer B. Davis - Jewish General Hospital

ClinicalTrials.gov Identifier:

NCT00990197

First received: October 5, 2009

Last updated: NA

Last verified: October 2009

History: No changes posted

Purpose

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.

Condition	Intervention
Smoking Cessation	Drug: Transdermal nicotine patch


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Safety of Transdermal Nicotine Immediately Following an Acute Coronary Syndrome: The STADIA Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by Sir Mortimer B. Davis - Jewish General Hospital:

Primary Outcome Measures:

The total duration of ischemic episodes [ Time Frame: Day 1 and Day 2 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Patient adherence to study protocol [ Time Frame: Day 1, Day 7, Day 14 ] [ Designated as safety issue: No ]
Incidence of arrhythmia [ Time Frame: Day 1 and Day 2 ] [ Designated as safety issue: Yes ]
Heart rate [ Time Frame: Day 1 and Day 2 ] [ Designated as safety issue: Yes ]
Systolic and diastolic blood pressure [ Time Frame: Day 1 and Day 2 ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	30
Study Start Date:	June 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Day 1 Patients randomized to wearing the patch on day 1 will apply a patch on the morning of their treatment day and keep it on for 24 hours. These patients will not wear a patch on day 2.	Drug: Transdermal nicotine patch Subjects will apply the nicotine patch on the morning of their treatment day and will keep it on for 24 hours. Other Name: Nicoderm CQ, Biovail Pharmaceuticals
Active Comparator: Day 2 Patients randomized to wearing the patch on day 2 will apply a patch on the morning of their treatment day and keep it on for 24 hours. These patients will not wear a patch on day 1.	Drug: Transdermal nicotine patch Subjects will apply the nicotine patch on the morning of their treatment day and will keep it on for 24 hours. Other Name: Nicoderm CQ, Biovail Pharmaceuticals

Show Detailed Description

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00990197

Locations


Canada, Quebec
SMDB Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2

Sponsors and Collaborators

Sir Mortimer B. Davis - Jewish General Hospital

Canadian Tobacco Control Research Initiative

Investigators


Principal Investigator:	Mark J Eisenberg, MD MPH	Jewish General Hospital/McGill University

More Information

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Responsible Party:	Mark J. Eisenberg, MD MPH, Jewish General Hospital/McGill University
ClinicalTrials.gov Identifier:	NCT00990197 History of Changes
Other Study ID Numbers:	05-023, 016026
Study First Received:	October 5, 2009
Last Updated:	October 5, 2009
Health Authority:	Canada: Canadian Institutes of Health Research Canada: Ethics Review Committee

Keywords provided by Sir Mortimer B. Davis - Jewish General Hospital:


Pilot study Randomized clinical trial Smoking cessation Acute coronary syndrome Transdermal nicotine patch

Additional relevant MeSH terms:


Acute Coronary Syndrome Angina Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Pain Signs and Symptoms Vascular Diseases Nicotine	Autonomic Agents Cholinergic Agents Cholinergic Agonists Ganglionic Stimulants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Nicotinic Agonists Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 27, 2015

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