Smoking Cessation for Patients With Acute Coronary Syndrome (ACS)

Acute Coronary Syndrome Clinical Trial

— PATPAC  

Official title:

Effectiveness of a Managed Care Smoking Cessation Program in Patients With Acute Coronary Syndrome Based on Nicotine Replacement as a Treatment and a Cognitive-behavioral Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987597
• Other study ID #: LRB0801
• Secondary ID: EUDRACT : 2008-0
• Status: Completed
• Phase: N/A
• First received: September 30, 2009
• Last updated: December 23, 2016
• Start date: September 2008
• Est. completion date: April 2010

Study information

• Verified date: November 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to assess if a personal care program of smokers hospitalised for acute coronary syndrome can change the smoking habits as compared with similar patients in conventional care program at 6 months. The program includes a cognitive-behavioural approach associated with a nicotine replacement treatment presented as an obligatory non optional treatment. Patients are men and women of less than 70 years old hospitalised for acute coronary syndrome. Major exclusion criteria is the presence of another dependence. The program includes a cognitive-behavioural approach based on the specific technique of "exposure" and the prescription of nicotine patch considered as other usual cardiologic treatments for at least 6 months. The end point is the smoking habits at 6 months classified as: no smoking confirmed by CO measurement, smoking or doubtful (declaration of no smoking by the patient but a CO level > 10 ppm). 72 patients in each group will be included in 2 majors sites.

Description:

The cognitive behavioural approach group : This group will receive an inclusion visit at first, then two "cigaret exposures cessions" during hospitalisation. Thereafter-one week after he's out- the patient will come for 5 follow up visits consisting in the specific technique of cigaret exposure and nicotinic treatment adjustment. Then the last visit, at six months, will tell us if the patient is an effective non smoker or not; We'll be also collecting psychological and medical informations (such as the treatment, IMC, cardiovascular check up and psychological tests). The control group : This group is managed as "usual" : the nurse gives very rapid recommendations to the patients concerning smoking cessation. Nicotinic substitutes are proposed to the patients but the patient must find them by itself.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: April 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients are men and women of less than 70 years old

• Hospitalised for acute coronary syndrome in cardiology Intensive Care Unit

• Active smoking >5 cigarettes/day

• Has given consent to participate in the study and haven't expressed its opposition the exploitation of data as part of the study

Exclusion Criteria:

• Presence of another dependence : alcohol abuse avowed or strongly suspected, addiction to drugs, high dose benzodiazepine dependence. clinical assessment

• Major psychiatric disorders or history. clinical assessment

• Treatment with lithium and neuroleptic. clinical assessment

• Patient whose cardiac problem could lead to hemodynamic instability during 48 h after admission.

• Patient scheduled for programmed hospitalisation within 6 months after release from hospital (>3 days long, including coronary bypass)

• Patients presenting another severe pathology requiring 6 months specific treatments. clinical assessment

• Patient which cannot understand or read French

• Patient with possible side-effect to nicotine substitute

• Patient unaffiliated to any social security regime

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Smoking
• Syndrome

Intervention

Behavioral:
• Technique of in-vivo exposure (cigarette) and mental image exposure (craving)
Nicotine replacement
• conventional follow-up
nicotinic substitutes

Locations

Country	Name	City	State
France	CHU Lariboisière, APHP, Cardiology	Paris	Ile de France

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ministry of Health, France, National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The smoking habits at 6 months classified as : no smoking confirmed by CO measurement, smoking or doubtful (declaration of no smoking by the patient but a CO level > 10 ppm).		6 month	No
Secondary	Assessment depending of age classes, sex, anxiety scale and other psychological characteristics		6 month	No