Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medical or interventional therapy for rhythm control in atrial fibrillation (antiarrhythmic drugs, ablation, electric cardio version), Usual care for atrial fibrillation.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke, Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study will determine whether early, comprehensive, rhythm control therapy prevents adverse cardiovascular outcome in patients with acute ischemic stroke and atrial fibrillation compared to usual care.
Detailed description
Atrial fibrillation is the single most frequent cause of ischemic stroke and associated with a high risk of recurrent stroke and cardiovascular complications. Usual care comprises oral anticoagulation and rate control. However, it is unclear, whether early rhythm control therapy reduces the risk of recurrent stroke and cardiovascular outcomes in stroke patients with atrial fibrillation. The Early treatment of Atrial fibrillation for Stroke prevention Trial in acute STROKE (EAST-STROKE) will be an investigator-initiated, prospective, randomized, open, blinded outcome assessment (PROBE) interventional multi-center trial to test whether early, comprehensive, rhythm control therapy prevents adverse cardiovascular outcome in patients with acute ischemic stroke and atrial fibrillation compared to usual care. Primary outcome is a composite of recurrent stroke, cardiovascular death, and hospitalization due to worsening of heart failure or acute coronary syndrome. Secondary outcomes will involve a comprehensive array of clinical and safety parameters, health and socio-economic outcomes including patient reported outcome measures. In an adaptive design, up to 1,746 patients will be enrolled to demonstrate the expected treatment effect with 90% power.
Interventions
- Other Medical or interventional therapy for rhythm control in atrial fibrillation (antiarrhythmic drugs, ablation, electric cardio version)
Therapy for early rhythm control will be either by use of approved antiarrhythmic drugs (e.g. amiodarone, dronedarone, flecainide, propafenone), approved approaches and devices for ablation, or electric cardio version. - Other Usual care for atrial fibrillation
Usual care for atrial fibrillation according to current guidelines. Usual care will mainly comprise rate control by approved drugs. We expect, that usual care will also comprise therapy for rhythm control in a small group of patients.
Primary outcome measures
- Time to first recurrent stroke, cardiovascular death, or hospitalization due to worsening of heart failure or due to acute coronary syndrome. [Time frame: Through study completion, an average of 42 months]
Secondary outcome measures (12)
- Time to first recurrent stroke [Time frame: Through study completion, an average of 42 months]
- Time to cardiovascular death [Time frame: Through study completion, an average of 42 months]
- Time to first hospitalization due to worsening of heart failure [Time frame: Through study completion, an average of 42 months]
- Time to hospitalization due to acute coronary syndrome [Time frame: Through study completion, an average of 42 months]
- Time to recurrent AF [Time frame: Through study completion, an average of 42 months]
- Cardiovascular hospitalization [Time frame: Through study completion, an average of 42 months]
- All-cause hospitalizations [Time frame: Through study completion, an average of 42 months]
- Time in sinus rhythm [Time frame: Through study completion, an average of 42 months]
- Functional status assessed by the modified Rankin Scale [Time frame: at 12 and 24 months]
- Quality of life assessed by the EuroQol five-dimensional questionnaire (EQ-5D) [Time frame: at 12 and 24 months]
- Cognitive function assessed by the Montreal Cognitive Assessment (MoCA) [Time frame: at 12 and 24 months]
- Cost of therapy [Time frame: Through study completion, an average of 42 months]
Eligibility criteria
Inclusion criteria
- Acute ischemic stroke in the previous four weeks, diagnosed by imaging (CT or MRI) or clinical diagnosis
- Possibility to start the trial treatment within 4 weeks after stroke, and as soon as clinically justifiable
- AF first detected ≤1 year prior to randomization
- Informed consent
Exclusion criteria
- End-stage cancer or life-expectancy < 12 months due to other advanced co-morbid illness
- Prior AF ablation or surgical therapy of AF
- Patients not suitable for rhythm control of AF due to cardiac conditions
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Germany · 1 center
- University Medical Center Hamburg-Eppendorf — Hamburg
Publications
- Jensen M, Zapf A, Buchholz A, Mohl A, Andrade JG, Cameron A, Campbell BCV, Fischer U, Hill MD, Kelly P, Kalman JM, Loh P, Molina C, Guasch E, Metzner A, Ng GA, Pagola J, Pontes-Neto OM, Reichlin T, Salman RA, Shoamanesh A, Sposato LA, van der Worp HB, Kirchhof P, Thomalla G. Early treatment of Atrial fibrillation for Stroke prevention Trial in acute STROKE (EAST-STROKE): protocol for an internatio PMID 42153760
Identifiers
NCT: NCT05293080 · EAST-STROKE