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 (Adult, Senior)
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

Publications:

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.

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.

Frid D, Ockene IS, Ockene JK, Merriam P, Goldberg R, Kristeller J, Barrett S. Severity of angiographically proven coronary artery disease predicts smoking cessation. Am J Prev Med. 1991 May-Jun;7(3):131-5.

Brummett BH, Babyak MA, Mark DC, Williams RB, Siegler IC, Clapp-Channing N, Barefoot JC. Predictors of smoking cessation in patients with a diagnosis of coronary artery disease. J Cardiopulm Rehabil. 2002 May-Jun;22(3):143-7.

Hughes JR. Tobacco withdrawal in self-quitters. J Consult Clin Psychol. 1992 Oct;60(5):689-97.

Stapleton J. Cigarette smoking prevalence, cessation and relapse. Stat Methods Med Res. 1998 Jun;7(2):187-203.

Rigotti NA, Arnsten JH, McKool KM, Wood-Reid KM, Pasternak RC, Singer DE. Smoking by patients in a smoke-free hospital: prevalence, predictors, and implications. Prev Med. 2000 Aug;31(2 Pt 1):159-66.

Jorenby DE, Hatsukami DK, Smith SS, Fiore MC, Allen S, Jensen J, Baker TB. Characterization of tobacco withdrawal symptoms: transdermal nicotine reduces hunger and weight gain. Psychopharmacology (Berl). 1996 Nov;128(2):130-8.

Benowitz NL, Fitzgerald GA, Wilson M, Zhang Q. Nicotine effects on eicosanoid formation and hemostatic function: comparison of transdermal nicotine and cigarette smoking. J Am Coll Cardiol. 1993 Oct;22(4):1159-67.

Mulligan SC, Masterson JG, Devane JG, Kelly JG. Clinical and pharmacokinetic properties of a transdermal nicotine patch. Clin Pharmacol Ther. 1990 Mar;47(3):331-7.

Gourlay S. The pros and cons of transdermal nicotine therapy. Med J Aust. 1994 Feb 7;160(3):152-9. Review.

Benowitz NL. Drug therapy. Pharmacologic aspects of cigarette smoking and nicotine addition. N Engl J Med. 1988 Nov 17;319(20):1318-30. Review.

Kaijser L, Berglund B. Effect of nicotine on coronary blood-flow in man. Clin Physiol. 1985 Dec;5(6):541-52.

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. Review.

Palatini P, Pessina AC, Graniero GR, Canali C, Mormino P, Dorigatti F, Accurso V, Michieletto M, Ferrarese E, Vriz O, et al. [The relationship between overweight, life style and casual and 24-hour pressures in a population of male subjects with mild hypertension. The results of the HARVEST study]. G Ital Cardiol. 1995 Aug;25(8):977-89. Italian.

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.

Mahmarian JJ, Moyé 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.

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.

Rietbrock N, Kunkel S, Wörner 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.

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. 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.

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.

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.

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.

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. Review.

Barnes PJ. New concepts in chronic obstructive pulmonary disease. Annu Rev Med. 2003;54:113-29. Epub 2001 Dec 3. Review.

Zevin S, Benowitz NL. Drug interactions with tobacco smoking. An update. Clin Pharmacokinet. 1999 Jun;36(6):425-38. Review.

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.

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.

Ottervanger JP, Festen JM, de Vries AG, Stricker BH. Acute myocardial infarction while using the nicotine patch. Chest. 1995 Jun;107(6):1765-6.

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.

Pierce JR Jr. Stroke following application of a nicotine patch. Ann Pharmacother. 1994 Mar;28(3):402.

Jackson M. Cerebral arterial narrowing with nicotine patch. Lancet. 1993 Jul 24;342(8865):236-7.

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.

Treating tobacco dependence: a report of the Surgeon General. Washington, DC: Department of Health and Human Services, 2000.

Freedman D PRPR. Statistics. New York: Norton Publishers, 1978.

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.

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. 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.

Fiore MC. US public health service clinical practice guideline: treating tobacco use and dependence. Respir Care. 2000 Oct;45(10):1200-62. Review.

Silagy C, Lancaster T, Stead L, Mant D, Fowler G. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2001;(3):CD000146. Review. Update in: Cochrane Database Syst Rev. 2002;(4):CD000146.

Silagy C, Lancaster T, Stead L, Mant D, Fowler G. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2002;(4):CD000146. Review. Update in: Cochrane Database Syst Rev. 2004;(3):CD000146.

Hughes JR, Glaser M. Transdermal nicotine for smoking cessation. Health Values 1993; 17(2):25-31.

American Medical Association. Drug Evaluations Annual 1994. Chicago: American Medical Association 1993.

Palmer KJ, Buckley MM, Faulds D. Transdermal Nicotine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy as an aid to smoking cessation. Drugs. 1992 Sep;44(3):498-529. Review.

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.

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. 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.

Heatherton TF, Kozlowski LT, Frecker RC, Fagerström KO. The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27.

Moyer D. Chapter 13: Physical fitness and carbon monoxide. Tobacco Reference Guide 2000;30-34.


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:


Syndrome Acute Coronary Syndrome Disease Pathologic Processes 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

ClinicalTrials.gov processed this record on September 27, 2016

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