Language: BG BG
← Back to results
Active (not recruiting) Phase 4 2025-521260-35-00

Early treatment of Atrial fibrillation for Stroke prevention Trial in acute STROKE (EAST-STROKE)

Phase 4 – monitoring after market approval
Conditions: acute ischemic stroke and atrial fibrillation (AF)

Sponsor: University Medical Center Hamburg-Eppendorf

trial.available_in: БГ
Overview
Trial status: Authorised Each of the components of the primary outcome (each analysed as time to first event): recurrent ischemic stroke, haemor-rhagic stroke, unclassified stroke, cardiovascular death, hospitalization due to worsening of heart failure, and hospitalization due to ACS, Recurrent disabling stroke (as time to first event), Recurrent AF (as time to first event), Cardiac rhythm (sinus rhythm vs. AF) at 12 and 24 months, Unplanned cardiovascular hospitalization (as time to first hospitalization), Number of cardiovascular hospitalizations, Change from baseline in left ventricular function (left ventricular ejection fraction [LVEF]) at 24 months, Functional status assessed with the modified Rankin Scale (mRS) at 12 and 24 months, Quality of life assessed with the EuroQol five-dimensional questionnaire (EQ-5D) and Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) domains on physical and mental health at 12 and 24 months, Cognitive function assessed with the Montreal Cognitive Assessment (MoCA) at 12 and 24 months, Cost of therapy A composite of first recurrent ischaemic stroke, haemorrhagic stroke, unclassified stroke, cardiovascular death, or hospitaliza-tion due to worsening of heart failure or due to acute coronary syndrome (ACS), analysed as time to the first occurrence of one of the aforementioned components.
Description
Each of the components of the primary outcome (each analysed as time to first event): recurrent ischemic stroke, haemor-rhagic stroke, unclassified stroke, cardiovascular death, hospitalization due to worsening of heart failure, and hospitalization due to ACS, Recurrent disabling stroke (as time to first event), Recurrent AF (as time to first event), Cardiac rhythm (sinus rhythm vs. AF) at 12 and 24 months, Unplanned cardiovascular hospitalization (as time to first hospitalization), Number of cardiovascular hospitalizations, Change from baseline in left ventricular function (left ventricular ejection fraction [LVEF]) at 24 months, Functional status assessed with the modified Rankin Scale (mRS) at 12 and 24 months, Quality of life assessed with the EuroQol five-dimensional questionnaire (EQ-5D) and Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) domains on physical and mental health at 12 and 24 months, Cognitive function assessed with the Montreal Cognitive Assessment (MoCA) at 12 and 24 months, Cost of therapy
Who can participate
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 1035 participants
Interventions
PROPAFENONE HYDROCHLORIDE
Drug
AMIODARONE HYDROCHLORIDE
Drug
DRONEDARONE HYDROCHLORIDE
Drug
FLECAINIDE ACETATE
Drug
Locations 3
Germany (1)
Netherlands (1)
Spain (1)
Technical details
Status
Active (not recruiting)
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
11.09.2025
Registry ID
2025-521260-35-00
Source
euclinicaltrials.eu
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.