NCT03153020

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
633

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

September 11, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

1.3 years

First QC Date

May 11, 2017

Last Update Submit

November 20, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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: 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.

    1 year post a stroke or transient ischemic attack

Study Arms (1)

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.

Other: Patients with stroke or transient ischemic attack

Interventions

Determination of factors associated to the conformity to secondary prevention treatment 1, 2 and 3 years post a stroke or transient ischemic attack.

Cohort of patients with stroke or transient ischemic attack

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with stroke or transient ischemic attack of the Rhone area

You may qualify if:

  • 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

You may not qualify if:

  • Hemorrhagic stroke,
  • Patient institutionalized in the year following the stroke / transient ischemic attack,
  • Patient unable to take treatment alone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche

Lyon, 69423, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

StrokeIschemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 15, 2017

Study Start

September 11, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations