NOACs for Stroke Prevention in Patients With Atrial Fibrillation and Previous ICH (NASPAF-ICH)

Population Health Research Institute (PHRI)

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation; Intracerebral Hemorrhage

Treatments: Drug: NOAC; Drug: Acetylsalicylic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02998905

NASPAF-ICH

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

NOAC

Experimental group

Description:

Apixaban or dabigatran or edoxaban or rivaroxaban

Treatment:

Drug: NOAC

Acetylsalicylic Acid

Active Comparator group

Description:

Acetylsalicylic acid

Treatment:

Drug: Acetylsalicylic Acid