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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03153020
Other study ID # 69HCL17_0037
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 11, 2017
Est. completion date December 31, 2019

Study information

Verified date November 2021
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 633
Est. completion date December 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
France Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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.
1 year post a stroke or transient ischemic attack
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