- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00990197
The Safety of Transdermal Nicotine Immediately Following an Acute Coronary Syndrome (STADIA)
The Safety of Transdermal Nicotine Immediately Following an Acute Coronary Syndrome: The STADIA Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective
The STADIA Pilot Study will be used to evaluate the feasibility of conducting a three-year multi-centre trial investigating the long-term safety and efficacy outcomes associated with transdermal nicotine use immediately following an acute coronary syndrome (ACS).
Rationale
Patients who initially survive an ACS are at high risk of recurrent cardiac events or cardiovascular death. Within the first 6 months alone, 12% of patients will die or suffer another ACS, while another 23% will require revascularization for angina. Patients who are able to quit smoking reduce their chances of suffering a recurrent ACS or cardiovascular death within the next year by ≥ 50%. After surviving an ACS, most patients are highly motivated to stop smoking. However, as nicotine is an extremely addictive psychoactive drug, up to 60% of patients who attempt to quit relapse. Hospitalization following an ACS provides an opportunity for smokers to quit, as smoking while in hospital is prohibited. However, abstinence while hospitalized also precipitates intense nicotine withdrawal symptoms, which are largely responsible for the high rates of smoking relapse. Nicotine replacement therapy (NRT) can ameliorate many of these symptoms and increase the chances that smokers continue to abstain from tobacco use after discharge. Of the available NRTs, transdermal nicotine is associated with the least severe cardiovascular effects, as it delivers nicotine more gradually (with lower peak values) than nicotine gum or inhalers. Although transdermal nicotine more than doubles long-term smoking cessation rates when compared with placebo, it is rarely prescribed by physicians in the weeks immediately following an ACS because the possible cardiovascular effects of nicotine after an ACS have yet to be systematically evaluated.
Methods
A total of 30 patients will be randomized within 48-hours of suffering an ACS from the Jewish General Hospital (Montreal, QC) and collaborating centres. Prior to randomization, all patients will receive standardized smoking cessation counselling. Subjects who satisfy the inclusion and exclusion criteria for the trial will be randomized within 48 hours of suffering an ACS to wear a transdermal nicotine patch on either day 1 or day 2 of the study period. Subjects will apply a patch the morning of their treatment day and keep it on for 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. Twenty-four hour Holter monitoring will be used to measure heart rate, incidence of arrhythmia, and the duration of ischemic events at day 1 and day 2 of the study period. Systolic and diastolic blood pressure will be assessed via 24-hour Ambulatory blood pressure monitoring (ABPM). ABPM will be used on day 1 and day 2 of the study period. On day 1 the study nurse will record the severity of nicotine withdrawal symptoms, side effects, any smoking relapses and if so, how many cigarettes were smoked, and any medications they are currently taking. On day 7 and 14 patients will be contacted by telephone to determine the severity of nicotine withdrawal symptoms, any smoking relapses and if so, how many cigarettes were smoked and any medications they are currently taking. Cardiovascular events will be assessed by patient monitoring and by a study nurse. Nicotine withdrawal symptoms according to the Hughes-Hatsukami symptom scale and common nicotine patch side effects, severity-rated on a five-point scale, will be determined through study nurse inquiries on days 1, 7, and 14 (6). Carbon monoxide monitors will be used to measure levels of expired CO at baseline. Participants whose levels of expired CO exceed 10 ppm will be classified as smokers.
Significance
If shown to be safe and effective, transdermal nicotine will have a major impact on the secondary prevention of recurrent cardiac events on the 20,000 Canadian smokers who suffer an ACS each year.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1E2
- SMDB Jewish General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Subjects will apply the nicotine patch on the morning of their treatment day and will keep it on for 24 hours.
Other Names:
|
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.
|
Subjects will apply the nicotine patch on the morning of their treatment day and will keep it on for 24 hours.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The total duration of ischemic episodes
Time Frame: Day 1 and Day 2
|
Day 1 and Day 2
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient adherence to study protocol
Time Frame: Day 1, Day 7, Day 14
|
Day 1, Day 7, Day 14
|
Incidence of arrhythmia
Time Frame: Day 1 and Day 2
|
Day 1 and Day 2
|
Heart rate
Time Frame: Day 1 and Day 2
|
Day 1 and Day 2
|
Systolic and diastolic blood pressure
Time Frame: Day 1 and Day 2
|
Day 1 and Day 2
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mark J Eisenberg, MD MPH, Jewish General Hospital/McGill University
Publications and helpful links
General Publications
- Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
- Joseph AM, Norman SM, Ferry LH, Prochazka AV, Westman EC, Steele BG, Sherman SE, Cleveland M, Antonuccio DO, Hartman N, McGovern PG. The safety of transdermal nicotine as an aid to smoking cessation in patients with cardiac disease. N Engl J Med. 1996 Dec 12;335(24):1792-8. doi: 10.1056/NEJM199612123352402. Erratum In: N Engl J Med. 2007 Jun 14;356(24):2554. Antonnucio, DO [corrected to Antonuccio, DO].
- Tzivoni D, Keren A, Meyler S, Khoury Z, Lerer T, Brunel P. Cardiovascular safety of transdermal nicotine patches in patients with coronary artery disease who try to quit smoking. Cardiovasc Drugs Ther. 1998 Jul;12(3):239-44. doi: 10.1023/a:1007757530765.
- Sauer WH, Berlin JA, Strom BL, Miles C, Carson JL, Kimmel SE. Cigarette yield and the risk of myocardial infarction in smokers. Arch Intern Med. 2002 Feb 11;162(3):300-6. doi: 10.1001/archinte.162.3.300.
- Cardiovascular Disease Surveillance. Laboratory Centre for Disease Control, Statistics Canada 2002, Candian Institutes for Health Information (CIHI), 2002.
- Nicotine replacement therapy for patients with coronary artery disease. Working Group for the Study of Transdermal Nicotine in Patients with Coronary artery disease. Arch Intern Med. 1994 May 9;154(9):989-95.
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- Kaijser L, Berglund B. Effect of nicotine on coronary blood-flow in man. Clin Physiol. 1985 Dec;5(6):541-52. doi: 10.1111/j.1475-097x.1985.tb00767.x.
- Transdermal nicotine for smoking cessation. Six-month results from two multicenter controlled clinical trials. Transdermal Nicotine Study Group. JAMA. 1991 Dec 11;266(22):3133-8.
- Pickering TG, Schwartz JE, James GD. Ambulatory blood pressure monitoring for evaluating the relationships between lifestyle, hypertension and cardiovascular risk. Clin Exp Pharmacol Physiol. 1995 Mar;22(3):226-31. doi: 10.1111/j.1440-1681.1995.tb01986.x.
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- Zevin S, Jacob P 3rd, Benowitz NL. Dose-related cardiovascular and endocrine effects of transdermal nicotine. Clin Pharmacol Ther. 1998 Jul;64(1):87-95. doi: 10.1016/S0009-9236(98)90026-1.
- Mahmarian JJ, Moye LA, Nasser GA, Nagueh SF, Bloom MF, Benowitz NL, Verani MS, Byrd WG, Pratt CM. Nicotine patch therapy in smoking cessation reduces the extent of exercise-induced myocardial ischemia. J Am Coll Cardiol. 1997 Jul;30(1):125-30. doi: 10.1016/s0735-1097(97)00128-9.
- Longo LD. The biological effects of carbon monoxide on the pregnant woman, fetus, and newborn infant. Am J Obstet Gynecol. 1977 Sep 1;129(1):69-103. doi: 10.1016/0002-9378(77)90824-9. No abstract available.
- Rietbrock N, Kunkel S, Worner W, Eyer P. Oxygen-dissociation kinetics in the blood of smokers and non-smokers: interaction between oxygen and carbon monoxide at the hemoglobin molecule. Naunyn Schmiedebergs Arch Pharmacol. 1992 Jan;345(1):123-8. doi: 10.1007/BF00175479.
- Allred EN, Bleecker ER, Chaitman BR, Dahms TE, Gottlieb SO, Hackney JD, Pagano M, Selvester RH, Walden SM, Warren J. Short-term effects of carbon monoxide exposure on the exercise performance of subjects with coronary artery disease. N Engl J Med. 1989 Nov 23;321(21):1426-32. doi: 10.1056/NEJM198911233212102. Erratum In: N Engl J Med 1990 Apr 5;322(14):1019.
- Allen SS, Hatsukami D, Gorsline J. Cholesterol changes in smoking cessation using the transdermal nicotine system. Transdermal Nicotine Study Group. Prev Med. 1994 Mar;23(2):190-6. doi: 10.1006/pmed.1994.1026.
- Morrow JD, Frei B, Longmire AW, Gaziano JM, Lynch SM, Shyr Y, Strauss WE, Oates JA, Roberts LJ 2nd. Increase in circulating products of lipid peroxidation (F2-isoprostanes) in smokers. Smoking as a cause of oxidative damage. N Engl J Med. 1995 May 4;332(18):1198-203. doi: 10.1056/NEJM199505043321804.
- Peters RW, Benowitz NL, Valenti S, Modin G, Fisher ML. Electrophysiologic effects of cigarette smoking in patients with and without chronic beta-blocker therapy. Am J Cardiol. 1987 Nov 1;60(13):1078-82. doi: 10.1016/0002-9149(87)90356-0.
- Gillum RF, Ingram DD, Makuc DM. White blood cell count and stroke incidence and death. The NHANES I epidemiologic follow-up study. Am J Epidemiol. 1994 May 1;139(9):894-902. doi: 10.1093/oxfordjournals.aje.a117095.
- Grimm RH Jr, Neaton JD, Ludwig W. Prognostic importance of the white blood cell count for coronary, cancer, and all-cause mortality. JAMA. 1985 Oct 11;254(14):1932-7.
- Hansen PR. Role of neutrophils in myocardial ischemia and reperfusion. Circulation. 1995 Mar 15;91(6):1872-85. doi: 10.1161/01.cir.91.6.1872.
- Barnes PJ. New concepts in chronic obstructive pulmonary disease. Annu Rev Med. 2003;54:113-29. doi: 10.1146/annurev.med.54.101601.152209. Epub 2001 Dec 3.
- Zevin S, Benowitz NL. Drug interactions with tobacco smoking. An update. Clin Pharmacokinet. 1999 Jun;36(6):425-38. doi: 10.2165/00003088-199936060-00004.
- Dacosta A, Guy JM, Tardy B, Gonthier R, Denis L, Lamaud M, Cerisier A, Verneyre H. Myocardial infarction and nicotine patch: a contributing or causative factor? Eur Heart J. 1993 Dec;14(12):1709-11. doi: 10.1093/eurheartj/14.12.1709.
- Warner JG Jr, Little WC. Myocardial infarction in a patient who smoked while wearing a nicotine patch. Ann Intern Med. 1994 Apr 15;120(8):695. doi: 10.7326/0003-4819-120-8-199404150-00023. No abstract available.
- Ottervanger JP, Festen JM, de Vries AG, Stricker BH. Acute myocardial infarction while using the nicotine patch. Chest. 1995 Jun;107(6):1765-6. doi: 10.1378/chest.107.6.1765.
- Hwang SL WM. Heart attacks reported in patch users still smoking. Wall Street Journal 1992;(June 19):B1.
- Fredrickson PA, Hurt RD, Lee GM, Wingender L, Croghan IT, Lauger G, Gomez-Dahl L, Offord KP. High dose transdermal nicotine therapy for heavy smokers: safety, tolerability and measurement of nicotine and cotinine levels. Psychopharmacology (Berl). 1995 Dec;122(3):215-22. doi: 10.1007/BF02246542.
- Pierce JR Jr. Stroke following application of a nicotine patch. Ann Pharmacother. 1994 Mar;28(3):402. doi: 10.1177/106002809402800320. No abstract available.
- Jackson M. Cerebral arterial narrowing with nicotine patch. Lancet. 1993 Jul 24;342(8865):236-7. doi: 10.1016/0140-6736(93)92323-l. No abstract available.
- Jorenby DE, Smith SS, Fiore MC, Hurt RD, Offord KP, Croghan IT, Hays JT, Lewis SF, Baker TB. Varying nicotine patch dose and type of smoking cessation counseling. JAMA. 1995 Nov 1;274(17):1347-52.
- Arnaot MR. Treating heart disease. Nicotine patches may not be safe. BMJ. 1995 Mar 11;310(6980):663-4. doi: 10.1136/bmj.310.6980.663c. No abstract available.
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- Wilson K, Gibson N, Willan A, Cook D. Effect of smoking cessation on mortality after myocardial infarction: meta-analysis of cohort studies. Arch Intern Med. 2000 Apr 10;160(7):939-44. doi: 10.1001/archinte.160.7.939.
- Tang JL, Law M, Wald N. How effective is nicotine replacement therapy in helping people to stop smoking? BMJ. 1994 Jan 1;308(6920):21-6. doi: 10.1136/bmj.308.6920.21. Erratum In: BMJ 1994 Mar 5;308(6929):626.
- Fiore MC, Smith SS, Jorenby DE, Baker TB. The effectiveness of the nicotine patch for smoking cessation. A meta-analysis. JAMA. 1994 Jun 22-29;271(24):1940-7.
- Silagy C, Mant D, Fowler G, Lodge M. Meta-analysis on efficacy of nicotine replacement therapies in smoking cessation. Lancet. 1994 Jan 15;343(8890):139-42. doi: 10.1016/s0140-6736(94)90933-4.
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- Greenland S, Satterfield MH, Lanes SF. A meta-analysis to assess the incidence of adverse effects associated with the transdermal nicotine patch. Drug Saf. 1998 Apr;18(4):297-308. doi: 10.2165/00002018-199818040-00005.
- Moyer D. Chapter 13: Physical fitness and carbon monoxide. Tobacco Reference Guide 2000;30-34.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Acute Coronary Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- 05-023
- 016026
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