The Safety of Transdermal Nicotine Immediately Following an Acute Coronary Syndrome (STADIA)
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ClinicalTrials.gov Identifier: NCT00990197 |
Recruitment Status :
Suspended
(Difficulties with enrollment.)
First Posted : October 6, 2009
Last Update Posted : October 6, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoking Cessation | Drug: Transdermal nicotine patch | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Safety of Transdermal Nicotine Immediately Following an Acute Coronary Syndrome: The STADIA Pilot Study |
Study Start Date : | June 2005 |
Estimated Primary Completion Date : | July 2009 |
Estimated Study Completion Date : | December 2009 |

Arm | Intervention/treatment |
---|---|
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 |
- The total duration of ischemic episodes [ Time Frame: Day 1 and Day 2 ]
- Patient adherence to study protocol [ Time Frame: Day 1, Day 7, Day 14 ]
- Incidence of arrhythmia [ Time Frame: Day 1 and Day 2 ]
- Heart rate [ Time Frame: Day 1 and Day 2 ]
- Systolic and diastolic blood pressure [ Time Frame: Day 1 and Day 2 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00990197
Canada, Quebec | |
SMDB Jewish General Hospital | |
Montreal, Quebec, Canada, H3T 1E2 |
Principal Investigator: | Mark J Eisenberg, MD MPH | Jewish General Hospital/McGill University |
Responsible Party: | Mark J. Eisenberg, MD MPH, Jewish General Hospital/McGill University |
ClinicalTrials.gov Identifier: | NCT00990197 |
Other Study ID Numbers: |
05-023 016026 |
First Posted: | October 6, 2009 Key Record Dates |
Last Update Posted: | October 6, 2009 |
Last Verified: | October 2009 |
Pilot study Randomized clinical trial Smoking cessation Acute coronary syndrome Transdermal nicotine patch |
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Nicotine Ganglionic Stimulants Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |