Smoking Cessation After Acute Coronary Syndrome

NCT03209622 | Completed DMC

• 1 other identifier: PMEMonastir
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled trial was conducted in cardiology department and smoking cessation center of University Hospital of Monastir (Tunisia). All smokers Hospitalized for ACS were included. Participants were randomly assigned to either group "A", initiating Nicotine replacement therapy (NRT) in intra-hospitalization or a control group "B" that received NRT after hospital discharge. The end point assessment was smoking abstinence at 24 weeks following randomization, defined as self-reported abstinence in the past week before the 24 week clinic visit confirmed by a measured exhaled carbon monoxide ≤8 ppm. Data were analyzed by intention to treat.

Conditions

Smoking; Acute Coronary Syndrome; Recurrence

Keywords

Smoking Cessation; Acute Coronary Syndrome; Cardiology

Outcome Measures

Primary Outcomes (1)

• smoking cessation rates with NRT among patients hospitalized for acute coronary syndrome

  smoking cessation rates with NRT when began in-hospitalization, against that began after hospital discharge

  24 weeks after acute coronary syndrome

Secondary Outcomes (1)

• smoking cessation duration with NRT among patients hospitalized for acute coronary syndrome

  24 weeks after acute coronary syndrome

Study Arms (2)

A intervention

EXPERIMENTAL

intervention = Nicotine replacement therapy (NRT): initiated in cardiology intensive care unit, Some hours after acute coronary syndrome. Drug: One or two pachs for each ARM, depending of number of cigarettes consummed every day. The dose is decreased every 4 weeks. The patient leave with an appointment to the external consultation for follow-up.

Procedure: Nicotine replacement therapy delivred in cardiology intensive care unit versus Nicotine replacement therapy delivered after hospital discharge; Drug: Nicotine patch

B: control

ACTIVE COMPARATOR

Intervention: Nicotine replacement therapy (NRT) initiated after hospital discharge, some days after acute coronary syndrome. The patient leave with an appointment to the external consultation for follow-up without pach of nicotine.One or two pachs for each ARM, depending of number of cigarettes consummed every day. The dose is decreased every 4 weeks.

Procedure: Nicotine replacement therapy delivred in cardiology intensive care unit versus Nicotine replacement therapy delivered after hospital discharge; Other: the external consultation

Interventions

Nicotine replacement therapy delivred in cardiology intensive care unit versus Nicotine replacement therapy delivered after hospital discharge PROCEDURE

when patient is admitted in intensive care of cardiology for acute coronary syndrome he is randomized to Arm A or Arm B

A intervention; B: control

Nicotine patch DRUG

Arm A

A intervention

the external consultation OTHER

without patch

B: control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Smoking is a taboo for Tunisian women especially that live in Monastir, it does not declare their consumptions and the inclusion of the woman can be at the origin of a selection bias
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• the refusal of assistance of smoking cessation, inability to follow-up clinical visit (professional, regional or physical hindrance), diagnosis of depression or of serious health condition at admission (ventilated patient, cardiogenic shock, etc).

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Abroug

Monastir, 5000, Tunisia

Location

Related Publications (7)

• Cahill K, Lindson-Hawley N, Thomas KH, Fanshawe TR, Lancaster T. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2016 May 9;2016(5):CD006103. doi: 10.1002/14651858.CD006103.pub7.

  PMID: 27158893 BACKGROUND

• Barth J, Jacob T, Daha I, Critchley JA. Psychosocial interventions for smoking cessation in patients with coronary heart disease. Cochrane Database Syst Rev. 2015 Jul 6;2015(7):CD006886. doi: 10.1002/14651858.CD006886.pub2.

  PMID: 26148115 BACKGROUND

• Yahagi K, Joner M, Virmani R. Impact of smoking on coronary heart disease: is there a smoker's paradox? Coron Artery Dis. 2015 Sep;26(6):466-8. doi: 10.1097/MCA.0000000000000274. No abstract available.

  PMID: 26217891 BACKGROUND

• Baccouche H, Belguith AS, Boubaker H, Grissa MH, Bouida W, Beltaief K, Sekma A, Fredj N, Bzeouich N, Zina Z, Boukef R, Soltani M, Nouira S. Acute coronary syndrome among patients with chest pain: Prevalence, incidence and risk factors. Int J Cardiol. 2016 Jul 1;214:531-5. doi: 10.1016/j.ijcard.2015.11.065. Epub 2015 Nov 11.

  PMID: 26586217 BACKGROUND

• Holtrop JS, Stommel M, Corser W, Holmes-Rovner M. Predictors of smoking cessation and relapse after hospitalization for acute coronary syndrome. J Hosp Med. 2009 Mar;4(3):E3-9. doi: 10.1002/jhm.415.

  PMID: 19301384 BACKGROUND

• Chow CK, Jolly S, Rao-Melacini P, Fox KA, Anand SS, Yusuf S. Association of diet, exercise, and smoking modification with risk of early cardiovascular events after acute coronary syndromes. Circulation. 2010 Feb 16;121(6):750-8. doi: 10.1161/CIRCULATIONAHA.109.891523. Epub 2010 Feb 1.

  PMID: 20124123 BACKGROUND

• Windle SB, Bata I, Madan M, Abramson BL, Eisenberg MJ. A randomized controlled trial of the efficacy and safety of varenicline for smoking cessation after acute coronary syndrome: design and methods of the Evaluation of Varenicline in Smoking Cessation for Patients Post-Acute Coronary Syndrome trial. Am Heart J. 2015 Oct;170(4):635-640.e1. doi: 10.1016/j.ahj.2015.07.010. Epub 2015 Jul 17.

  PMID: 26386786 BACKGROUND

MeSH Terms

Conditions

Smoking; Acute Coronary Syndrome; Recurrence; Smoking Cessation

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Behavior; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Health Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Aymen Elhraiech, A. professor

  University hospital of Monastir: Avenue Farhat HACHED 5000 Monastir Tunisia

  STUDY CHAIR

• Asma Sriha Belguith, Professor

  University hospital of Monastir: Avenue Farhat HACHED 5000 Monastir Tunisia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of epidemiology and preventive medicine, Principal Investigator, Associate Professor

Model Details: Participants hospitalized for acute coronary syndrome were randomly assigned to either group "A", initiating Nicotine replacement therapy (NRT) in intra-hospitalization or a control group "B" that received NRT after hospital discharge.

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: July 6, 2017
• Study Start: January 2, 2015
• Primary Completion: November 1, 2017
• Study Completion: December 30, 2019
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)