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Sponsors and Collaborators: |
McGill University Canadian Institutes of Health Research (CIHR) Heart and Stroke Foundation of Ontario |
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Information provided by: | McGill University |
ClinicalTrials.gov Identifier: | NCT00689611 |
Patients who continue to smoke after a heart attack have a 35% increased risk of a recurrent event or death compared with those who quit. Many patients attempt to stop smoking after a heart attack, but relapse rates approach 66%. A variety of smoking cessation aids have been shown to be effective for the general population. However, bupropion is the only non-nicotine replacement therapy shown to improve abstinence rates in healthy young smokers. Furthermore, nicotine replacement therapies (NRTs) are contraindicated in the immediate period following a heart attack because of the undesirable effects of nicotine. Although bupropion has been successfully used to reduce smoking rates in healthy young populations, its efficacy and safety in the setting of patients recovering from an ACS is unknown. These patients, if they continue to smoke, are at exceptionally high risk for recurrent cardiac events. If bupropion is effective in this population, it will have a major impact on secondary prevention of recurrent clinical events in patients who suffer a heart attack.
Condition | Intervention | Phase |
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Acute Coronary Syndrome Myocardial Infarction Smoking |
Drug: Bupropion HCl ER Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Zyban as an Effective Smoking Cessation Aid for Patients Following an Acute Coronary Syndrome: The ZESCA Trial |
Estimated Enrollment: | 1500 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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P: Placebo Comparator
Half of patients will receive placebo for 9 weeks.
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Drug: Placebo
Placebo
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A: Active Comparator
Half of patients will receive bupropion for 9 weeks.
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Drug: Bupropion HCl ER
150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks
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Patients who continue smoking after ACS have a 35% increased risk of reinfarction or death compared with those who quit. Many patients attempt to stop smoking after an acute coronary syndrome (ACS), but relapse rates approach 66%. A variety of smoking cessation aids have been shown to be effective for the general population. However, physicians are reluctant to use a nicotine-based therapy because of its hemodynamic effects. Bupropion is the only non-nicotine replacement therapy shown to improve abstinence rates in healthy young smokers by approximately 50%. Although bupropion has successfully been used to reduce smoking rates in healthy young populations, its efficacy and safety in the setting of patients recovering from an ACS is unknown.
The ZESCA Trial will directly compare the efficacy and safety of bupropion versus placebo as a means of reducing smoking rates in patients following an ACS. The ZESCA Trial will be a multi-center effort, coordinated from the Jewish General Hospital/McGill University (Montreal, Quebec). A total of 1500 patients will be randomized following an ACS but before hospital discharge via an Internet web site. Prior to the start of the treatment, patients in both treatment arms will receive a standard physician-administered counseling session regarding smoking cessation. Patients will begin treatment in-hospital and will be monitored in-hospital for ≥ 2 days prior to discharge. Half the patients will receive bupropion for 9 weeks and the other half will receive placebo pills for 9 weeks. Patients receiving bupropion will take 150 mg once per day for 3 days and then 150 mg twice per day for the remainder of 9 weeks. Prior to discharge, the patients will receive an information sheet listing the possible side effects of bupropion. They will be advised to consult the treating physician should they experience any listed side effects. While in-hospital, patients will have quit smoking and they will be instructed to not restart smoking when discharged. Phone calls to the patients will be made by the study nurses at weeks 1 and 2 of the 9-week treatment period. In addition, the patients will have clinic visits at weeks 4 and 9 as well as months 6 and 12. Smoking abstinence will be assessed at 4 weeks, 9 weeks, 6 months, and 12 months after randomization. Smoking abstinence will be defined as the complete abstinence in the week prior to the clinic visits and levels of exhaled carbon monoxide ≤ 10 ppm. Side effects of bupropion in patients following ACS as well as clinical events following initiation of treatment will be measured at weeks 1-8 (by telephone calls), and weeks 4 and 9 as well as months 6 and 12 (by clinic visits). Withdrawal symptoms will also be assessed by the nurses during their weekly calls.
Trials previously conducted with bupropion involved young healthy smokers. The ZESCA trial will be the first to examine the utility of bupropion in a group of patients with an ACS. These patients, if they continue to smoke, are at exceptionally high risk for recurrent cardiac events. If bupropion is effective in this population, it will have a major impact on secondary prevention of recurrent clinical events in patients who suffer an ACS.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Scottsdale Cardiovascular Research Institute | Recruiting |
Scottsdale, Arizona, United States | |
Contact: Dewayne Thurmond, RN 480-248-3377 dthurmond@scresearch.org | |
Principal Investigator: Krishnaswami Vijayaraghavan, MD | |
United States, District of Columbia | |
DC VA Medical Center | Recruiting |
Washington, District of Columbia, United States | |
Contact: Helen Sheriff, RN 202-745-8000 ext 7288 helen.sheriff@va.gov | |
Principal Investigator: Michael Greenberg, MD | |
United States, Michigan | |
Bay Regional Medical Center | Recruiting |
Bay City, Michigan, United States | |
Contact: Suzanne Vasquez, RN 989-894-8616 suzannevasquez@bhsnet.org | |
Principal Investigator: Kochunni Mohan, MD | |
Bangladesh | |
National Heart Foundation of Bangladesh | Active, not recruiting |
Dhaka, Bangladesh | |
Canada, Alberta | |
Peter Lougheed Centre of the Calgary General Hospital | Recruiting |
Calgary, Alberta, Canada | |
Contact: Peggy Beresford, RN 403-943-4524 peggy.beresford@calgaryhealthregion.ca | |
Principal Investigator: Peter Giannoccaro, MD | |
University of Alberta Hospital | Recruiting |
Edmonton, Alberta, Canada | |
Contact: Bonnie Woloschuk, RN 780-492-4860 bonniew@ualberta.ca | |
Principal Investigator: Ian Paterson, MD | |
Canada, Manitoba | |
St. Boniface General Hospital | Recruiting |
Winnipeg, Manitoba, Canada | |
Contact: Noreen Garanhel, RN 204-237-2705 ngaranhel@sbgh.mb.ca | |
Principal Investigator: Sat Sharma, MD | |
Canada, New Brunswick | |
New Brunswick Heart Centre | Recruiting |
Saint Johns, New Brunswick, Canada | |
Contact: Elizabeth Collings, RN 506- 648-7121 colel@reg2.health.nb.ca | |
Principal Investigator: Sohrab Lutchmedial, MD | |
Canada, Nova Scotia | |
Valley Regional Hospital | Recruiting |
Kentville, Nova Scotia, Canada | |
Contact: Judy Dewolfe, RN 902-679-2657 ext 1360 jdewolfe@avdha.nshealth.ca | |
Principal Investigator: Howard Wightman, MD | |
Canada, Ontario | |
St. Michael's Hospital | Recruiting |
Toronto, Ontario, Canada | |
Contact: Larah Ross, MD 416-864-6060 ext 6161 rossl@smh.toronto.on.ca | |
Principal Investigator: Beth Abramson, MD | |
The Ottawa Hospital, General Campus | Recruiting |
Ottawa, Ontario, Canada | |
Contact: Julie Finnigan, RN 613-737-8135 jfinnigan@ottawahospital.on.ca | |
Principal Investigator: Andreas Wielgosz, MD | |
Canada, Quebec | |
SMBD- Jewish General Hospital | Recruiting |
Montreal, Quebec, Canada, H3T 1E2 | |
Contact: Sonia Grandi, MSc 514-340-8222 ext 3240 sonia.grandi@mail.mcgill.ca | |
Contact: Mark J Eisenberg, MD, MPH 514-340-8222 ext 3564 mark.eisenberg@mcgill.ca | |
Principal Investigator: Mark J Eisenberg, MD, MPH | |
Montreal General Hospital | Recruiting |
Montreal, Quebec, Canada | |
Contact: Nancy Branco, RN 514-934-1934 ext 44649 nancy.branco@muhc.mcgill.ca | |
Principal Investigator: Louise Pilote, MD, MPH, PhD | |
CSSS de la Region de Thetford | Recruiting |
Thetford Mines, Quebec, Canada | |
Contact: Francine Dumont, RN 418-338-7740 IRA_inc@hotmail.com | |
Principal Investigator: Claude Lauzon, MD | |
Hopital Sacre-Coeur de Montreal | Recruiting |
Montreal, Quebec, Canada | |
Contact: Celine Groulx, RN 514-338-2222 ext 3083 c-groulx@crhsc.umontreal.ca | |
Principal Investigator: Jean Diodati, MD | |
CHA Hotel-Dieu de Levis | Recruiting |
Levis, Quebec, Canada | |
Contact: Francine Dumont, RN 418-833-5750 clincardiolevis@bellnet.ca | |
Principal Investigator: Francois Grondin, MD | |
CSSS de Sorel-Tracy | Active, not recruiting |
Sorel, Quebec, Canada | |
Hotel-Dieu | Recruiting |
Montreal, Quebec, Canada | |
Contact: Renee Duclos, RN 514-890-8000 ext 14803 recherche.cardio.hd.chum@ssss.gouv.qc.ca | |
Principal Investigator: Paolo Costi, MD | |
India | |
Centre for Chronic Disease Control | Recruiting |
New Delhi, India | |
Contact: Anuradha Tripathi, MD + 9111 26850117 anuradha@ccdcindia.org | |
Principal Investigator: D Prabhakaran, MD, DM, MSc | |
Iran, Islamic Republic of, Iran | |
Isfahan Cardiovascular Research Centre | Active, not recruiting |
Isfahan, Iran, Iran, Islamic Republic of | |
Tunisia | |
University Hospital F. Bourguiba | Recruiting |
Sousse, Tunisia | |
Contact: Hassen Ghannem, MD +21673219496 hassen.ghannem@rns.tn | |
Principal Investigator: Hassen Ghannem, MD |
Principal Investigator: | Mark J Eisenberg, MD, MPH | Jewish General Hospital/ McGill University |
Responsible Party: | Jewish General Hospital/ McGill University ( Mark J. Eisenberg, MD MPH ) |
Study ID Numbers: | ZESCA 9197, ISRCTN75356261 |
Study First Received: | May 30, 2008 |
Last Updated: | May 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00689611 |
Health Authority: | Canada: Health Canada |
Acute coronary syndrome Myocardial infarction Smoking cessation Zyban Secondary intervention post-ACS |
Smoking Necrosis Heart Diseases Myocardial Ischemia Bupropion Acute Coronary Syndrome |
Vascular Diseases Neoplasm Metastasis Ischemia Infarction Myocardial Infarction |
Habits Disease Pathologic Processes Syndrome Cardiovascular Diseases |