Prevention of Stroke by Left Atrial Appendage Closure in Atrial Fibrillation Patients After Intracerebral Hemorrhage

NCT02830152 | Active Not Recruiting DMC

• 1 other identifier: STROKECLOSE
• Study Type: interventional
• Target: 750
• Locations: 4 countries
• Sites: 17

Brief Summary

Intracerebral hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) poses a particular dilemma for thromboprophylaxis. Left atrial appendage occlusion (LAAO) is a non-pharmacological approach to prevent cardiac embolism in NVAF. The risk-benefit ratio of LAAO in patients with NVAF after ICH is unknown. The aim of STROKECLOSE is to assess the effect of LAAO to reduce the incidence stroke, bleeding and cardiovascular mortality in patients with NVAF and prior ICH.

Conditions

Atrial Fibrillation; Stroke; Intracerebral Hemorrhage

Keywords

Stroke; intracerebral hemorrhage; left atrial appendage occlusion; atrial fibrillation; oral anticoagulation; preventive therapy

Outcome Measures

Primary Outcomes (1)

• Composite endpoint of stroke (ischemic or hemorrhagic), systemic embolism, life-threatening or major bleeding and all-cause mortality

  This endpoint will be assessed in patients with paroxysmal, persistent or long-standing NVAF and with ICH within 6 months prior to enrollment. The effect of LAAO will be compared to medical therapy at the treating physician's discretion as a control.

  up to 5 years after randomization

Secondary Outcomes (10)

• Number of participants with a device-related complication

  up to 45 days after randomization

• Number of Participants with a device success

  up to 45 days after randomization

• Number of Participants with a Technical success

  up to 45 days after randomization

• Number of Participants with a Procedural success

  up to 45 days after randomization

• Number of Participants with Significant peridevice leak

  up to 45 days after randomization

Study Arms (2)

Left Atrial Appendage Occlusion (LAAO)

EXPERIMENTAL

The intervention is implantation of Amplatzer Amulet LAAO device within two months after randomization. Device implantation comprises a catheterization procedure using venous access and a transseptal puncture to obtain access to the left atrium (LA). Procedural imaging guidance is left to the physician's discretion and may include several techniques such as angiography/fluoroscopy, transesophageal echocardiography (TEE) and/or intracardiac echocardiography (ICE). Recommended post-implant antithrombotic therapy includes ASA therapy for at least 6 months, which may be combined with clopidogrel for the first 45 days after implantation.

Device: LAAO

Medical Therapy

ACTIVE COMPARATOR

The optimal medical therapy of stroke prevention in non-valvular atrial fibrillation (NVAF) after intracerebral hemorrhage (ICH) is not known. Therefore, it will be left to the discretion of the treating physician to decide if, when, and which pharmacological therapy will be prescribed. Available options include anticoagulation with oral anticoagulation (OAC) or novel oral anticoagulants (NOAC), antiplatelet therapy (including monotherapy and dual antiplatelet therapy) and no pharmacological antithrombotic therapy.

Drug: Medical Therapy

Interventions

LAAO DEVICE

The left atrial appendage is occluded with the AMPLATZER™ Amulet™ device, which offers a conformable disc and lobe designed for complete occlusion of the left atrial appendage.

Also known as: AMPLATZER™ Amulet™ (St. Jude Medical)

Left Atrial Appendage Occlusion (LAAO)

Medical Therapy DRUG

Available options included in Medical therapy are: anticoagulation with OAC or NOAC, antiplatelet therapy (including monotherapy and dual antiplatelet therapy) and no pharmacological antithrombotic therapy.

Also known as: Antiplatelet Therapy

Medical Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of paroxysmal, persistent or long-standing NVAF with CHA2DS2VASc score \>2.
• Clinical and CT/MRI evidence of ICH within 12 months but not less than 4 weeks prior to enrollment.
• Age \> 18 years.
• Signed informed consent.

You may not qualify if:

• ICH secondary to vascular malformation or tumors
• Estimated life expectancy of less than 1 year at eligibility assessment
• mRS \> 3 at enrollment
• Prior surgical LAA excision
• Planned combined interventional procedures at the time of enrollment

Sponsors & Collaborators

• Karolinska Institutet: lead
• Abbott Medical Devices: collaborator

Study Sites (17)

Aarhus University Hospital

Aarhus, Denmark

Location

Bispebjerg University Hospital

Bispebjerg, Denmark

Location

Rikshospitalet Glostrup

Glostrup Municipality, Denmark

Location

Herlev sjukhus

Herlev, Denmark

Location

Odenses Universitetssjukhus

Odense, Denmark

Location

Helsinki University Hospital

Helsinki, Finland

Location

North Karelia Central Hospital

Joensuu, Finland

Location

Kuopio University Hospital

Kuopio, Finland

Location

Turku University Hospital

Turku, Finland

Location

Vaasa Centralsjukhus

Vaasa, Finland

Location

Haukeland Universitetssjukhus

Bergen, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Universitetssjukhuset Skåne

Lund, Sweden

Location

Universitetssjukhuset

Örebro, Sweden

Location

Danderyd Hospital

Stockholm, Sweden

Location

Akademiska sjukhuset

Uppsala, Sweden

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Cerebral Hemorrhage

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Intracranial Hemorrhages; Hemorrhage

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Per Wester, MD

  Department of Clinical Sciences, Karolinska Institute, Danderyds hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 12, 2016
• Study Start: May 3, 2017
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting after publication and for 36 months.
• Access Criteria: A full description of the intended use of the data must be sent to the corresponding author for review and approval. Participant consent for data sharing is conditioned and new ethics approval may be required.

Locations

FI (5); NO (2); SE (5); DK (5)