Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitätsklinikum Hamburg-Eppendorf
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Medical or interventional therapy for rhythm control in atrial fibrillation (antiarrhythmic drugs, ablation, electric cardio version)
Other interventionTherapy 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.
Usual care for atrial fibrillation
Other interventionUsual 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.
Treatment groups
1,746 Participants
are divided into 2 treatment groupsGroup A: Early rhythm control therapyExperimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to first recurrent stroke, cardiovascular death, or hospitalization due to worsening of heart failure or due to acute coronary syndrome.
The primary outcome measure is a composite of first recurrent stroke, cardiovascular death, and hospitalization due to worsening of heart failure or due to acute coronary syndrome as recorded by study investigators
Time frame
Through study completion, an average of 42 monthsSecondary outcomes
1
Time to first recurrent stroke
Recurrent stroke as recorded by study investigators
Time frame
Through study completion, an average of 42 months2
Time to cardiovascular death
Time frame
Through study completion, an average of 42 months3
Time to first hospitalization due to worsening of heart failure
Hospitalization due to worsening of heart failure as recorded by study investigators
Time frame
Through study completion, an average of 42 months4
Time to hospitalization due to acute coronary syndrome
Hospitalization due to acute coronary syndrome as recorded by study investigators
Time frame
Through study completion, an average of 42 monthsOther outcomes
1
All-cause mortality
Death from any cause
Time frame
Through study completion, an average of 42 months2
Severe bleeding complications
Intracranial hemorrhage, major bleeding
Time frame
Through study completion, an average of 42 months3
Adverse events
Adverse events related to the study intervention with special emphasis on proarrhythmia and complications due to interventions
Time frame
Through study completion, an average of 42 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitätsklinikum Hamburg-Eppendorf
Lead sponsor
University Heart & Vascular Center Hamburg, Department of Cardiology
Collaborator
Department of Neurology, Royal Melbourne Hospital
Collaborator
Melbourne Heart Centre, Royal Melbourne Hospital
Collaborator
Hotchkiss Brain Institute, University of Calgary
Collaborator
Department of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht
Collaborator
UMC Utrecht
Collaborator
Edinburgh Clinical Trials Unit, Cerebrovascular Research Group, Centre for Clinical Brain Sciences, University of Edinburgh
Collaborator
Department of Cardiovascular Sciences, University of Leicester British Heart Foundation Cardiovascular Research Centre
Collaborator
CTC-NORTH
Collaborator
Stroke Alliance for Europe (SAFE)
Collaborator
Kompetenznetz Vorhofflimmern e.V. (AFNET)
Collaborator
Source ClinicalTrials.gov