NOACs for Stroke Prevention in Patients With Atrial Fibrillation and Previous ICH

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-26

Study Completion Date

2020-02-18

Brief Summary

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To determine the feasibility of a controlled trial examining the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) compared with ASA for stroke prevention in patients with a high-risk of atrial fibrillation and previous intracerebral hemorrhage.

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Detailed Description

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The NASPAF-ICH study is an open-label, randomized, controlled, phase II study that will assess the feasibility of a controlled trial examining the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) compared with acetylsalicylic acid (ASA) for stroke prevention in patients with high-risk atrial fibrillation and previous intracerebral hemorrhage, as well as provide evidence of efficacy and safety for planning of a phase III trial. Recruitment will occur at 10 high-volume stroke research centres across Canada over 2 years, at which 100 adult patients with high-risk atrial fibrillation (CHADS2 ≥2) and previous spontaneous or traumatic ICH (intraparenchymal or intraventricular hemorrhage while on or off anticoagulation) will be randomly assigned to receive a NOAC (particular agent at the discretion of the local investigator) or ASA 81 mg per day. Patients will be followed for a mean of 1 year to a common end-study date. The feasibility of recruitment will also be tested. The investigators estimate that five patients per year per centre can be recruited.

Conditions

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Atrial Fibrillation Intracerebral Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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NOAC

Apixaban or dabigatran or edoxaban or rivaroxaban

Group Type EXPERIMENTAL

NOAC

Intervention Type DRUG

Apixaban or dabigatran or edoxaban or rivaroxaban at recommended dosing for stroke prevention in atrial fibrillation. The particular agent is at the discretion of the local investigator.

Acetylsalicylic Acid

Acetylsalicylic acid

Group Type ACTIVE_COMPARATOR

Acetylsalicylic Acid

Intervention Type DRUG

Acetylsalicylic acid 81 mg/day

Interventions

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NOAC

Apixaban or dabigatran or edoxaban or rivaroxaban at recommended dosing for stroke prevention in atrial fibrillation. The particular agent is at the discretion of the local investigator.

Intervention Type DRUG

Acetylsalicylic Acid

Acetylsalicylic acid 81 mg/day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Previous primary intracerebral hemorrhage
* Atrial fibrillation (CHADS2 ≥ 2)

Exclusion Criteria

* Non-stroke indication for antiplatelet or anticoagulant therapy
* Recent intracerebral hemorrhage within 14 days
* Platelet count less than 100,000/mm3 at enrollment or other bleeding diathesis
* Prior symptomatic lobar intracerebral hemorrhage other than the qualifying event
* Uncontrollable hypertension consistently above SBP/DBP of 160/100 mmHg
* Known hypersensitivity to either ASA or NOACs
* Inability to adhere to study procedures

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No