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Completed

NCT Number: NCT03153020

Determinants of Adherence to Post-stroke/Transient Ischemic Attack Secondary Prevention Treatment: Cohort Study in the Rhône

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche

Lyon, 69423, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Patients with stroke or transient ischemic attack

Other

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

Primary outcomes

  1. 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.

  2. 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:

    • 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: OBSTACLE

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
May 15, 2017
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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