Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05293080
Other study ID # EAST-STROKE
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date September 2024
Est. completion date March 2029

Study information

Verified date December 2023
Source Universitätsklinikum Hamburg-Eppendorf
Contact Märit Jensen, MD
Phone +4940741053770
Email m.jensen@uke.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1746
Est. completion date March 2029
Est. primary completion date September 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (13)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf CTC-NORTH, Department of Cardiovascular Sciences, University of Leicester British Heart Foundation Cardiovascular Research Centre, Department of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht, Department of Neurology, Royal Melbourne Hospital, Edinburgh Clinical Trials Unit, Cerebrovascular Research Group, Centre for Clinical Brain Sciences, University of Edinburgh, Hotchkiss Brain Institute, University of Calgary, Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Kompetenznetz Vorhofflimmern e.V. (AFNET), Melbourne Heart Centre, Royal Melbourne Hospital, Stroke Alliance for Europe (SAFE), UMC Utrecht, University Heart & Vascular Center Hamburg, Department of Cardiology

Outcome

Type Measure Description Time frame Safety issue
Other All-cause mortality Death from any cause Through study completion, an average of 42 months
Other Severe bleeding complications Intracranial hemorrhage, major bleeding Through study completion, an average of 42 months
Other Adverse events Adverse events related to the study intervention with special emphasis on proarrhythmia and complications due to interventions Through study completion, an average of 42 months
Primary 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 Through study completion, an average of 42 months
Secondary Time to first recurrent stroke Recurrent stroke as recorded by study investigators Through study completion, an average of 42 months
Secondary Time to cardiovascular death Through study completion, an average of 42 months
Secondary Time to first hospitalization due to worsening of heart failure Hospitalization due to worsening of heart failure as recorded by study investigators Through study completion, an average of 42 months
Secondary Time to hospitalization due to acute coronary syndrome Hospitalization due to acute coronary syndrome as recorded by study investigators Through study completion, an average of 42 months
Secondary Time to recurrent AF Through study completion, an average of 42 months
Secondary Cardiovascular hospitalization Cardiovascular hospitalization as recorded by study investigators Through study completion, an average of 42 months
Secondary All-cause hospitalizations All-cause hospitalizations as recorded by study investigators Through study completion, an average of 42 months
Secondary Time in sinus rhythm Through study completion, an average of 42 months
Secondary Functional status assessed by the modified Rankin Scale Modified Ranking Scale ranging from 0 (no symptoms) to 6 (death) with lower values indicating better status at 12 and 24 months
Secondary Quality of life assessed by the EuroQol five-dimensional questionnaire (EQ-5D) The EQ-5D index will be calculated with higher values indicating better health state at 12 and 24 months
Secondary Cognitive function assessed by the Montreal Cognitive Assessment (MoCA) The MoCA ranges for 0 to 30, with higher values indicating better cognitive function at 12 and 24 months
Secondary Cost of therapy Through study completion, an average of 42 months
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study N/A
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting NCT05442203 - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease N/A
Completed NCT05599308 - Evaluation of Blood Pressure Monitor With AFib Screening Feature N/A
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation NCT05890274 - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO N/A
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Recruiting NCT05316870 - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation N/A
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT06283654 - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A