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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00228098
Other study ID # VF 20040136
Secondary ID
Status Recruiting
Phase N/A
First received September 26, 2005
Last updated September 27, 2005
Start date February 2005
Est. completion date February 2007

Study information

Verified date September 2005
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

Patients with stroke or transient ischemic attach should receive advise on smoking cessation. It is however unknown if an intensive smoking cessation program is better than ordinary advise on smoking cessation during hospitalisation for stroke or transient ischemic attack.

The aim of the study was to assess if an intensive smoking cessation program made more patients stop smoking after stroke or transient ischemic attack.


Description:

Patients with stroke or transient ischemic attach should receive advise on smoking cessation. It is however unknown if an intensive smoking cessation program is better than ordinary advise on smoking cessation during hospitalisation for stroke or transient ischemic attack.

The aim of the study was to assess if an intensive smoking cessation program made more patients stop smoking after stroke or transient ischemic attack.

Patients with stroke or transient ischemic attack are admitted to the department of neurology at Odense University hospital. Patient who are smokers on admission and age < 76 years, inhabitants in Funen County and with symptoms developed before admission will be offered participation in the study unless they have severe stroke, stroke more than 3 weeks before admission, other severe disease or unable to participate.

Study participants will be randomised to either usual short advise on smoking cessation or an intensive smoking cessation program. All participants will be followed-up for 6 months with regard to smoking habits.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date February 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Age < 76 years

- Inhabitant in Funen County

- Acute stroke or transient ischemic attack

- Symptoms with onset before admission

- Current smoker on admission

Exclusion Criteria:

- Severe stroke

- Current stroke onset more than 3 weeks before admission

- Other severe disease

- Unable to participate

Study Design

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


Intervention

Behavioral:
Smoking cessation


Locations

Country Name City State
Denmark Department of Neurology Odense Funen

Sponsors (4)

Lead Sponsor Collaborator
Odense University Hospital Danish Heart Foundation, Funen County, Hjernesagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Smoking cessation rate
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