[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100459054":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":39,"responsibleParty":235,"collaborators":24,"id":238,"slug":239,"hasResults":240,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":240,"sex":246,"minAge":247,"maxAge":24,"enrollmentInfo":248,"targetDuration":24,"studyType":251,"phases":252,"briefSummary":254,"conditions":255,"keywords":258,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":274},{"fullName":5,"class":6},"Sir Mortimer B. Davis - Jewish General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling)","ACTIVE_COMPARATOR","Patients in the combination therapy arm will be supplied funds and instructions for the purchase of e-cigarettes and cartridges\u002Fpods upon hospital discharge and at the week 4 and 12 clinic visits. As with standard NRTs such as the gum, inhaler, and lozenge, the investigators expect smokers will self-regulate administration according to their withdrawal symptoms. Use will be monitored via self-report for telephone follow-ups. At clinic visits, patients will be asked to bring their e-cigarettes, used and unused cartridges\u002Fpods, and purchasing receipts. Patients will be advised regarding the signs and symptoms of nicotine toxicity and of an allergic reaction.",[13],"Combination Product: Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling)",{"label":15,"type":6,"description":16,"interventionNames":17},"Varenicline Plus Counseling","All patients will begin varenicline in-hospital upon randomization. For the first 3 days, patients will take a 0.5 mg tablet once a day. They will then take a 0.5 mg tablet twice a day for the following 4 days, and one 1 mg tablet twice a day from day 8 onward for the remainder of the 12-week treatment. Use will be monitored via self-report for telephone follow-ups and return of all unused tablets at the end of the treatment period. Should a patient experience severe side effects (such as headache, nausea, vomiting, dizziness, dyspepsia, fatigue, insomnia, abnormal dreams, constipation, or flatulence) on day 8 onward, the varenicline dose should be reduced from 1 mg twice daily to 0.5 mg twice daily prior to study medication discontinuation.",[18],"Other: Varenicline Plus Counseling",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"COMBINATION_PRODUCT","Varenicline and nicotine e-cigarettes plus counseling",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Varenicline plus counseling",[15],[29,35],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Tabitha Finch","CONTACT","514-340-8222","23240","ASAP.Trial@ladydavis.ca",{"name":36,"role":31,"phone":32,"phoneExt":37,"email":38},"Carole Bohbot","22790","carole.bohbot@ladydavis.ca",[40,61,77,93,109,124,139,154,170,182,194,204,219],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Fraser Clinical Trials","RECRUITING","New Westminster","British Columbia","V3L 3W4","Canada","CA",{"type":49,"coordinates":50},"Point",[51,52],-122.91092,49.20678,{"lat":52,"lon":51},[55,58],{"name":56,"role":31,"phone":24,"phoneExt":24,"email":57},"Anjali Menon","amenon@fraserclinicaltrials.com",{"name":59,"role":60,"phone":24,"phoneExt":24,"email":24},"Sina Alipour","PRINCIPAL_INVESTIGATOR",{"facility":62,"status":42,"city":63,"state":64,"zip":65,"country":46,"countryCode":47,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Dr. Georges-L.-Dumont University Hospital Center","Moncton","New Brunswick","E1C 2Z3",{"type":49,"coordinates":67},[68,69],-64.7965,46.09454,{"lat":69,"lon":68},[72,75],{"name":73,"role":31,"phone":24,"phoneExt":24,"email":74},"Melissa Daigle","melissa.daigle@vitalitenb.ca",{"name":76,"role":60,"phone":24,"phoneExt":24,"email":24},"Jean-Francois Baril",{"facility":78,"status":42,"city":79,"state":80,"zip":81,"country":46,"countryCode":47,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"NL Health Sciences","St. John's","Newfoundland and Labrador","A1B 3V6",{"type":49,"coordinates":83},[84,85],-52.70931,47.56494,{"lat":85,"lon":84},[88,91],{"name":89,"role":31,"phone":24,"phoneExt":24,"email":90},"Shianne Beson","shianne.beson@nlhealthservices.ca",{"name":92,"role":60,"phone":24,"phoneExt":24,"email":24},"Mohammad Almutawa",{"facility":94,"status":42,"city":95,"state":96,"zip":97,"country":46,"countryCode":47,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Queen Elizabeth II Health Sciences Center","Halifax","Nova Scotia","B3H 3A7",{"type":49,"coordinates":99},[100,101],-63.57688,44.64269,{"lat":101,"lon":100},[104,107],{"name":105,"role":31,"phone":24,"phoneExt":24,"email":106},"David Fillmore","david.fillmore@nshealth.ca",{"name":108,"role":60,"phone":24,"phoneExt":24,"email":24},"Jafna Cox",{"facility":110,"status":42,"city":111,"state":112,"zip":24,"country":46,"countryCode":47,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"St. Joseph's Hospital","London","Ontario",{"type":49,"coordinates":114},[115,116],-81.23304,42.98339,{"lat":116,"lon":115},[119,122],{"name":120,"role":31,"phone":24,"phoneExt":24,"email":121},"Tim Hartley","Tim.Hartley@lhsc.on.ca",{"name":123,"role":60,"phone":24,"phoneExt":24,"email":24},"Neville Suskin",{"facility":125,"status":42,"city":126,"state":112,"zip":127,"country":46,"countryCode":47,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"University of Ottawa Heart Institute","Ottawa","K1Y 4W7",{"type":49,"coordinates":129},[130,131],-75.69812,45.41117,{"lat":131,"lon":130},[134,137],{"name":135,"role":31,"phone":24,"phoneExt":24,"email":136},"Ashley Baldwin","asbaldwin@ottawaheart.ca",{"name":138,"role":60,"phone":24,"phoneExt":24,"email":24},"Hassan Mir",{"facility":140,"status":42,"city":141,"state":112,"zip":142,"country":46,"countryCode":47,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Sunnybrook Health Sciences Centre","Toronto","M4N 3M5",{"type":49,"coordinates":144},[145,146],-79.39864,43.70643,{"lat":146,"lon":145},[149,152],{"name":150,"role":31,"phone":24,"phoneExt":24,"email":151},"Ambreen Syeda","ambreen.syeda@sunnybrook.ca",{"name":153,"role":60,"phone":24,"phoneExt":24,"email":24},"Eugene Crystal",{"facility":155,"status":42,"city":156,"state":157,"zip":158,"country":46,"countryCode":47,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Montreal Heart Institute","Montreal","Quebec","H1T 1C8",{"type":49,"coordinates":160},[161,162],-73.58781,45.50884,{"lat":162,"lon":161},[165,168],{"name":166,"role":31,"phone":24,"phoneExt":24,"email":167},"Marie-Gabrielle Lessard","marie-gabrielle.lessard@icm-mhi.org",{"name":169,"role":60,"phone":24,"phoneExt":24,"email":24},"Jean-Francois Tanguay",{"facility":171,"status":42,"city":156,"state":157,"zip":172,"country":46,"countryCode":47,"cosmosGeoPoint":173,"geoPoint":175,"contacts":176},"Centre Hospitalier de L'Universite de Montreal","H2X 3E4",{"type":49,"coordinates":174},[161,162],{"lat":162,"lon":161},[177,180],{"name":178,"role":31,"phone":24,"phoneExt":24,"email":179},"Benjamin Orcese","benjamin.orcese.chum@ssss.gouv.qc.ca",{"name":181,"role":60,"phone":24,"phoneExt":24,"email":24},"Stephane Elkouri",{"facility":183,"status":42,"city":156,"state":157,"zip":184,"country":46,"countryCode":47,"cosmosGeoPoint":185,"geoPoint":187,"contacts":188},"Montreal General Hospital","H3G 1A4",{"type":49,"coordinates":186},[161,162],{"lat":162,"lon":161},[189,192],{"name":190,"role":31,"phone":24,"phoneExt":24,"email":191},"Caroline Boudreault","caroline.boudreault@muhc.mcgill.ca",{"name":193,"role":60,"phone":24,"phoneExt":24,"email":24},"Thao Huynh",{"facility":195,"status":42,"city":156,"state":157,"zip":196,"country":46,"countryCode":47,"cosmosGeoPoint":197,"geoPoint":199,"contacts":200},"Jewish General Hospital","H3T 1E2",{"type":49,"coordinates":198},[161,162],{"lat":162,"lon":161},[201,202],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":34},{"name":203,"role":60,"phone":24,"phoneExt":24,"email":24},"Mark Eisenberg",{"facility":205,"status":42,"city":206,"state":157,"zip":207,"country":46,"countryCode":47,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Institut Universitaire de Cardiologie et de Pneumologie de Québec","Québec","G1V 4G5",{"type":49,"coordinates":209},[210,211],-71.21454,46.81228,{"lat":211,"lon":210},[214,217],{"name":215,"role":31,"phone":24,"phoneExt":24,"email":216},"Genevieve Pouliot","genevieve.pouliot.9@ulaval.ca",{"name":218,"role":60,"phone":24,"phoneExt":24,"email":24},"Tomas Cieza",{"facility":220,"status":42,"city":221,"state":222,"zip":223,"country":46,"countryCode":47,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"Royal University Hospital","Saskatoon","Saskatchewan","S7N 0W8",{"type":49,"coordinates":225},[226,227],-106.66892,52.13238,{"lat":227,"lon":226},[230,233],{"name":231,"role":31,"phone":24,"phoneExt":24,"email":232},"Rama Mangipudi","rkm352@mail.usask.ca",{"name":234,"role":60,"phone":24,"phoneExt":24,"email":24},"Jay Shavadia",{"type":60,"investigatorFullName":236,"investigatorTitle":237,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Mark Eisenberg, MD","Principal Investigator","100459054","phase-3-aggressive-smoking-cessation-trial-asap-100459054",false,"NCT05257629","Aggressive Smoking Cessation Trial (ASAP)","Aggressive Smoking Cessation Therapy Among People at Elevated Cardiovascular Risk (ASAP) Trial","ASAP","Inclusion Criteria:\n\n1. Patients currently hospitalized or being discharged from hospital who have suffered an ACS, defined as follows:\n\n   i. MI, defined by positive troponin T, troponin I, or CK-MB levels (as defined by institution-specific cut-offs) and ≥ 1 of the following:\n   1. Ischemic symptoms for ≥ 20 min;\n   2. Electrocardiogram (ECG) changes indicative of ischemia (ST-segment elevation or depression);\n   3. Development of pathological Q waves on the ECG\n\n   ii. Unstable angina with significant coronary artery disease, defined by all of the following:\n   1. Ischemic symptoms for ≥ 20 min;\n   2. ECG changes indicative of ischemia (ST-segment changes);\n   3. At least one lesion ≥ 50% on angiogram performed during the current hospitalization.\n\n   \\[Note: patients who undergo cardiac catheterization or percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery will be eligible provided they are able to start varenicline in-hospital and nicotine e-cigarette at discharge.\\]\n\n   OR\n\n   Outpatients with the following diagnoses\u002Fconditions:\n\n   i. Cardiovascular:\n   1. Coronary artery disease documented with angiography or coronary CT;\n   2. Previous ACS, MI, stable or UA;\n   3. Previous coronary revascularization (e.g. PCI or CABG). ii. Renovascular:\n\n   a. Chronic kidney disease. iii. Cerebrovascular:\n\n   a. Previous cerebral infarction or transient cerebral ischemic attack. iv. Peripheral vascular:\n   1. Abdominal aortic aneurysm \\> 3.0 cm or previous aortic aneurysm surgery;\n   2. Ankle-brachial pressure index of \\\u003C 0.9 or intermittent claudication;\n   3. Documented carotid artery disease;\n   4. Lower-limb amputation;\n   5. Previous lower-limb bypass surgery or angioplasty.\n\n   v. ≥1 risk factors:\n   1. BMI ≥ 27 kg\u002Fm2;\n   2. Dyslipidemia;\n   3. Family history (first degree relative: parents or siblings only) of coronary heart disease or stroke before the age of 60 years;\n   4. Hypertension;\n   5. Males aged ≥ 55 years\u002Ffemales aged ≥ 60 years;\n   6. Diabetes mellitus. vi. Heart-related conditions:\n\n   \u003C!-- -->\n\n   1. Atrial fibrillation or flutter;\n   2. Cardiomyopathy;\n   3. Heart failure;\n   4. Left ventricular hypertrophy (evidenced by echocardiography or ECG);\n   5. Valvular disease (evidenced by echocardiography).\n2. Smoked on average ≥ conventional cigarettes\u002Fday for the past year;\n3. Age ≥18 years;\n4. Motivated to quit smoking according to the Motivation To Stop Scale (MTSS) (≥ level 5);\n5. Able to understand and provide informed consent in English or French;\n6. If randomized to the combination arm (varenicline and e-cigarette plus counseling), willing and able to purchase e-cigarettes with the following properties: rechargeable, closed system that uses sealed cartridges or pods, tobacco or no flavor only, and nicotine strength of 20 mg\u002Fml (2%) or less;\n7. Likely to be available for 52 weeks of follow-up.\n\nExclusion Criteria:\n\n1. Pregnant or lactating females;\n2. Use of any of the following in the 30 days prior to eligibility assessment:\n\n   i. Varenicline or bupropion for smoking cessation; ii. Nicotine or non-nicotine e-cigarettes; iii. Other anti-craving medication (e.g., naltrexone, acamprosate) with the potential to alter substance-seeking behaviors;\n3. Use of nicotine replacement therapy (NRT) in the 7 days prior to eligibility assessment \\[Note: If participant is prescribed non-study NRT while hospitalized, they can continue using the non-study NRT until being discharged, even while taking the investigational products. Upon discharge, use of the non-study NRT should be stopped.\\];\n4. Use of varenicline or e-cigarettes (nicotine or non-nicotine) for ≥14 days consecutively in the past year;\n5. Previous serious adverse reaction to varenicline and\u002For e-cigarettes (nicotine or non-nicotine);\n6. NYHA or Killip Class III or IV at the time of randomization;\n7. Any unstable psychiatric disorder (as per enrolling physician);\n8. Renal impairment with creatinine levels ≥2 times upper limit of normal or eGFR ≤15;\n9. Use of any illegal drugs in the past year;\n10. Planned use of cannabis (smoked) or other tobacco products (smoked or other) during the study period. \\[Note: use of cannabis which is not smoked is permitted (e.g., edibles, ingested or vaped oils). However, methods which involve combustion could invalidate biochemical validation via exhaled carbon monoxide.\\]","ALL","18 Years",{"count":249,"type":250},798,"ESTIMATED","INTERVENTIONAL",[253],"PHASE3","The ASAP Trial is a 5-year, multi-centre, randomized controlled trial that will assess the efficacy, safety, and tolerability of aggressive smoking cessation therapy among people at elevated cardiovascular risk. It will recruit 798 adult patients smoking on average at least 10 conventional (tobacco) cigarettes per day who are motivated to quit smoking and have either been diagnosed with ACS requiring hospitalization or are outpatients at elevated cardiovascular risk. Patients will be randomized (1:1) to one of two treatment arms: (1) combination therapy of varenicline and nicotine e-cigarettes plus counseling or (2) varenicline plus counseling for 12 weeks, with 52-week follow-up.",[256,257],"Acute Coronary Syndrome","Cardiovascular Diseases",[259,260,261,262,263,264],"acute coronary syndrome","smoking cessation","randomized controlled trial","varenicline","e-cigarettes","cardiovascular disease","2025-04-24",{"date":267,"type":268},"2025-04-29","ACTUAL",{"date":270,"type":268},"2023-02-02",{"date":272,"type":250},"2027-03-07",{"name":5,"class":6},13]