StrokeOBSTACLENCT03153020
Determinants of Adherence to Post-stroke/Transient Ischemic Attack Secondary Prevention Treatment: Cohort Study in the Rhône
An observational study of Stroke and Transient Ischemic Attack, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The effectiveness of emergency management of acute ischemic stroke has improved considerably in recent years with thrombolysis and more recently thrombectomy. This improvement is accompanied by an increase in the number of stroke survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Transient Ischemic Attack
- What is being tested?
- Patients with stroke or transient ischemic attack
- How many people
- 633 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2017to 31 Dec 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stroke or transient ischemic attack of the Rhone area
Who may be able to join
- Consecutive patients treated for a stroke suspicion at the acute phase,
- with symptom onset (the last time the patient was seen without deficit ) less than 24 hours,
- Managed by the Rhône's emergency medical help service (SAMU), in one of the emergency unit or stroke unit of the Rhône area
- Having given their written consent for the extraction of their healthcare consumption data from the Health Insurance databases
Who cannot join
- Hemorrhagic stroke,
- Patient institutionalized in the year following the stroke / transient ischemic attack,
- Patient unable to take treatment alone.
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche
Lyon, 69423
About this study
The effectiveness of emergency management of acute ischemic stroke has improved considerably in recent years with thrombolysis and more recently thrombectomy. This improvement is accompanied by an increase in the number of stroke survivors. One of the major issues for these ever-increasing survivors is the prevention of recurrence. According to data from the 3 French registries, more than 20% of patients have at least one recurrence. Secondary prevention treatment has demonstrated his efficacy to prevent stroke recurrence.
This evolution justifies identifying factors associated with adherence to secondary prevention treatment, measured at 1 year post-stroke / transient ischemic attack (TIA), in patients included in the STROKE 69 cohort.
- Conditions
- Stroke, Transient Ischemic Attack
- Being tested
- Patients with stroke or transient ischemic attack
- 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.
Patients with stroke or transient ischemic attackOther
Determination of factors associated to the conformity to secondary prevention treatment 1, 2 and 3 years post a stroke or transient ischemic attack.
| Study group | Role | What they receive |
|---|---|---|
| Cohort of patients with stroke or transient ischemic attack | The cohort will be constituted of all consecutive patients admitted for a stroke or transient ischemic attack by the Rhône's emergency medical help service (SAMU), or in one of the emergency unit or stroke unit of the Rhône area, and presenting a symptom-onset (the last time the patient was seen without deficit) less than 24 hours. Receives: Other: Patients with stroke or transient ischemic attack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to secondary prevention treatment 1 year post a stroke or transient ischemic attack
The overall medication possession ratio is the average of the medication possession ratio calculated for each therapeutic class (antiplatelet agents, anticoagulants, antihypertensives, hypolipidemic agents and oral antidiabetics).
The medication possession ratio will be calculated from dispensing data from regional health insurance database and prescription data from the STROKE 69 study. For each patient, a medication possession ratio (CMA7 index) will be obtained by the ratio of the quantity of medication units dispensed to the quantity of medication units prescribed.
Measured: 1 year post a stroke or transient ischemic attack
Determination of factors influencing compliance with secondary prevention treatment 1 year post a stroke or transient ischemic attack
A phone call will be made to patients 1 year post a stroke or transient ischemic attack.
The following determinants will be studied in the 5 dimensions defined by World Health Organization:
- Socio-economic: level of education, profession, health insurance
- Patient and family-social environment: age, sex, marital status, lifestyle, level of patient support in the management of their treatment, representation of the disease and beliefs about medication
- Care pathway: management of stroke / TIA in emergency or neurovascular unit, admission to rehabilitation unit, medical consumption and therapeutics acts in the year following stroke / TIA
- Pathology: TIA or ischemic stroke, duration of hospitalization in acute phase and type of hospital, history of stroke or TIA, disability and autonomy, fatigue, anxiety and depression, comorbidities
- Treatments: therapeutic class and number of treatments / polymedication.
Measured: 1 year post a stroke or transient ischemic attack
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start11 Sep 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 633 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153020
- Sponsor's protocol ID
- 69HCL17_0037
- Acronym
- OBSTACLE
- Status last verified
- Nov 2025
- First submitted
- 11 May 2017
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoarau D, Ramos I, Termoz A, Fernandez V, Rambure M, Allemann SS, Derex L, Haesebaert J, Schott AM, Viprey M. Determinants of adherence to post-stroke/transient ischemic attack secondary prevention medications: A cohort study. Eur J Neurol. 2024 Oct;31(10):e16395. doi: 10.1111/ene.16395. Epub 2024 Jul 2.
PubMed 38953278
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Adherence to Post-stroke/Transient Ischemic Attack Secondary Prevention Treatment: Cohort Study in the Rhône
- ClinicalTrials.gov ID
- NCT03153020
- Acronym / sponsor ID
- OBSTACLE / 69HCL17_0037
- Conditions
- Stroke, Transient Ischemic Attack
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 633 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 15 May 2017 (actual)
- 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.
The effectiveness of emergency management of acute ischemic stroke has improved considerably in recent years with thrombolysis and more recently thrombectomy. This improvement is accompanied by an increase in the number of stroke survivors. One of the major issues for these ever-increasing survivors is the prevention of recurrence. According to data from the 3 French registries, more than 20% of patients have at least one recurrence. Secondary prevention treatment has demonstrated his efficacy to prevent stroke recurrence.
This evolution justifies identifying factors associated with adherence to secondary prevention treatment, measured at 1 year post-stroke / transient ischemic attack (TIA), in patients included in the STROKE 69 cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of patients with stroke or transient ischemic attack | – | Other: Patients with stroke or transient ischemic attackThe cohort will be constituted of all consecutive patients admitted for a stroke or transient ischemic attack by the Rhône's emergency medical help service (SAMU), or in one of the emergency unit or stroke unit of the Rhône area, and presenting a symptom-onset (the last time the patient was seen without deficit) less than 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stroke or transient ischemic attack of the Rhone area
Key inclusion criteria (4 listed)
- Consecutive patients treated for a stroke suspicion at the acute phase,
- with symptom onset (the last time the patient was seen without deficit ) less than 24 hours,
- Managed by the Rhône's emergency medical help service (SAMU), in one of the emergency unit or stroke unit of the Rhône area
- Having given their written consent for the extraction of their healthcare consumption data from the Health Insurance databases
Key exclusion criteria (3 listed)
- Hemorrhagic stroke,
- Patient institutionalized in the year following the stroke / transient ischemic attack,
- Patient unable to take treatment alone.
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 |
|---|---|---|
| Patients with stroke or transient ischemic attackDetermination of factors associated to the conformity to secondary prevention treatment 1, 2 and 3 years post a stroke or transient ischemic attack. | Other | Cohort of patients with stroke or transient ischemic attack |
Primary outcome
Compliance to secondary prevention treatment 1 year post a stroke or transient ischemic attack
Time frame: 1 year post a stroke or transient ischemic attack
The overall medication possession ratio is the average of the medication possession ratio calculated for each therapeutic class (antiplatelet agents, anticoagulants, antihypertensives, hypolipidemic agents and oral antidiabetics). The medication possession ratio will be calculated from dispensing data from regional health insurance database and prescription data from the STROKE 69 study. For each patient, a medication possession ratio (CMA7 index) will be obtained by the ratio of the quantity of medication units dispensed to the quantity of medication units prescribed.
Determination of factors influencing compliance with secondary prevention treatment 1 year post a stroke or transient ischemic attack
Time frame: 1 year post a stroke or transient ischemic attack
A phone call will be made to patients 1 year post a stroke or transient ischemic attack. The following determinants will be studied in the 5 dimensions defined by World Health Organization: 1. Socio-economic: level of education, profession, health insurance 2. Patient and family-social environment: age, sex, marital status, lifestyle, level of patient support in the management of their treatment, representation of the disease and beliefs about medication 3. Care pathway: management of stroke / TIA in emergency or neurovascular unit, admission to rehabilitation unit, medical consumption and therapeutics acts in the year following stroke / TIA 4. Pathology: TIA or ischemic stroke, duration of hospitalization in acute phase and type of hospital, history of stroke or TIA, disability and autonomy, fatigue, anxiety and depression, comorbidities 5. Treatments: therapeutic class and number of treatments / polymedication.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Results publication: PubMed 38953278Hoarau D, Ramos I, Termoz A, Fernandez V, Rambure M, Allemann SS, Derex L, Haesebaert J, Schott AM, Viprey M. Determinants of adherence to post-stroke/transient ischemic attack secondary prevention medications: A cohort study. Eur J Neurol. 2024 Oct;31(10):e16395. doi: 10.1111/ene.16395. Epub 2024 Jul 2.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Transient Ischemic Attack, run by Hospices Civils de Lyon at 1 site in France.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 25 Nov 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance to secondary prevention treatment 1 year post a stroke or transient ischemic attack (time frame: 1 year post a stroke or transient ischemic attack). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03153020, which also lists 1 linked publication.
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 25 Nov 2025.