StrokeNCT00228098
Smoking Cessation Intervention After Stroke or Transient Ischaemic Attack.
A study testing Smoking cessation in people with Stroke and Transient Ischemic Attack, run by Odense University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Transient Ischemic Attack
- What is being tested?
- Smoking cessation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2005to Feb 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age < 76 years
- Inhabitant in Funen County
- Acute stroke or transient ischemic attack
- Symptoms with onset before admission
- Current smoker on admission
Who cannot join
- Severe stroke
- Current stroke onset more than 3 weeks before admission
- Other severe disease
- Unable to participate
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Neurology
Odense, Funen, 5000 C
Søren Bak, MD, PhD., bak@hunderupnet.dk
About this study
Official title: Smoking Cessation Intervention After Stroke or Transient Ischaemic Attack. A Randomised Controlled Trial
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.
Read the detailed 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.
- Conditions
- Stroke, Transient Ischemic Attack
- Being tested
- Smoking cessation
- Medical subject headings
- Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startFeb 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Heart Foundation, Hjernesagen, Funen County
- Investigators
- Søren Bak, MD, PhD, Principal investigator, Department of Neurology, Odense University Hospital. 5000 Odense C. Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228098
- Sponsor's protocol ID
- VF 20040136
- Status last verified
- Sep 2005
- First submitted
- 26 Sep 2005
- Last updated
- 28 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation Intervention After Stroke or Transient Ischaemic Attack. A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00228098
- Acronym / sponsor ID
- VF 20040136
- Conditions
- Stroke, Transient Ischemic Attack
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Danish Heart Foundation, Hjernesagen, Funen County
- Study start
- Feb 2005
- Study completion
- Feb 2007
- First posted
- 28 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age < 76 years
- Inhabitant in Funen County
- Acute stroke or transient ischemic attack
- Symptoms with onset before admission
- Current smoker on admission
Key exclusion criteria (4 listed)
- Severe stroke
- Current stroke onset more than 3 weeks before admission
- Other severe disease
- Unable to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessation | Behavioural | – |
Primary outcome
Smoking cessation rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Søren Bak, MD, PhD principal investigator
Department of Neurology, Odense University Hospital. 5000 Odense C. Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation in people with Stroke and Transient Ischemic Attack, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking cessation rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2005.