- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03153020
Determinants of Adherence to Post-stroke/Transient Ischemic Attack Secondary Prevention Treatment: Cohort Study in the Rhône (OBSTACLE)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
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Lyon, Frankrike, 69423
- Hospices Civils de Lyon, Pole Information Médicale Evaluation Recherche
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
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.
|
Determination of factors associated to the conformity to secondary prevention treatment 1, 2 and 3 years post a stroke or transient ischemic attack.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Compliance to secondary prevention treatment 1 year post a stroke or transient ischemic attack
Tidsram: 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
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Determination of factors influencing compliance with secondary prevention treatment 1 year post a stroke or transient ischemic attack
Tidsram: 1 year post a stroke or transient ischemic attack
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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:
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1 year post a stroke or transient ischemic attack
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 69HCL17_0037
Plan för individuella deltagardata (IPD)
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