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Smoking Cessation After Acute Coronary Syndrome (SCACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209622
Recruitment Status : Unknown
Verified July 2017 by Sriha Belguith_asma, University of Monastir.
Recruitment status was:  Recruiting
First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Sriha Belguith_asma, University of Monastir

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.

Condition or disease Intervention/treatment Phase
Smoking Acute Coronary Syndrome Recurrence Procedure: Nicotine replacement therapy delivred in cardiology intensive care unit versus Nicotine replacement therapy delivered after hospital discharge Drug: Nicotine patch Other: the external consultation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nicotine Replacement Therapy After Acute Coronary Syndrome
Actual Study Start Date : January 2, 2015
Estimated Primary Completion Date : November 1, 2017
Estimated Study Completion Date : December 30, 2019


Arm Intervention/treatment
Experimental: A intervention

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

Drug: Nicotine patch
Arm A

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

Other: the external consultation
without patch




Primary Outcome Measures :
  1. smoking cessation rates with NRT among patients hospitalized for acute coronary syndrome [ Time Frame: 24 weeks after acute coronary syndrome ]
    smoking cessation rates with NRT when began in-hospitalization, against that began after hospital discharge


Secondary Outcome Measures :
  1. smoking cessation duration with NRT among patients hospitalized for acute coronary syndrome [ Time Frame: 24 weeks after acute coronary syndrome ]
    smoking cessation duration with NRT when began in-hospitalization, against that began after hospital discharge



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients aged more than 18 years, hospitalized with an ACS actively smoking at the time of inclusion, motivated to quit smoking, able to provide informed consent and willing to participate in a clinical study including a follow-up examination every 2 weeks after hospital discharge.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209622


Contacts
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Contact: Hela Abroug, PHD 0021652692600 hela-abr@hotmail.com
Contact: Manel Ben Fredj, PHD 0021652720545 manel-ben-fredj@hotmail.fr

Locations
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Tunisia
Abroug Recruiting
Monastir, Tunisia, 5000
Contact: Manel Ben Fredj, PHD    0021652720545    manel-ben-fredj@hotmail.fr   
Contact: Aymen Elhraiech, A.Professor    0021699744608    elhraiech.aymen@yahoo.com   
Principal Investigator: Asma Sriha Belguith, Professor         
Sponsors and Collaborators
University of Monastir
Investigators
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Study Chair: Aymen Elhraiech, A. professor University hospital of Monastir: Avenue Farhat HACHED 5000 Monastir Tunisia
Principal Investigator: Asma Sriha Belguith, Professor University hospital of Monastir: Avenue Farhat HACHED 5000 Monastir Tunisia
Publications:

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Responsible Party: Sriha Belguith_asma, Head of epidemiology and preventive medicine, Principal Investigator, Associate Professor, University of Monastir
ClinicalTrials.gov Identifier: NCT03209622    
Other Study ID Numbers: PMEMonastir
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: individual participant data have been invited and study results have been presented

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sriha Belguith_asma, University of Monastir:
Smoking Cessation
Acute Coronary Syndrome
Cardiology
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Recurrence
Disease
Pathologic Processes
Disease Attributes
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