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

Recruiting

Phase 2 Results N/A

Trial Description

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.

Detailed 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.

Conditions

Interventions

  • Acetylsalicylic acid Drug
    Other Names: Aspirin 81 mg
    Intervention Desc: Acetylsalicylic acid 81 mg/day
    ARM 1: Kind: Experimental
    Label: Acetylsalicylic Acid
    Description: Acetylsalicylic acid
  • NOAC Drug
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: NOAC
    Description: Apixaban or dabigatran or rivaroxaban (or edoxaban if approved by Health Canada)

Outcomes

Type Measure Time Frame Safety Issue
Primary Recruitment rate Through study completion; ~ 30 months
Primary Composite of ischemic stroke and recurrent intracerebral hemorrhage Through study completion; average of 1 year
Secondary Refusal rate Through study completion; average of 1 year
Secondary Retention rate Through study completion; average of 1 year
Secondary Ischemic stroke Through study completion; average of 1 year
Secondary Intracerebral hemorrhage Through study completion; average of 1 year
Secondary Fatal stroke Through study completion; average of 1 year
Secondary Myocardial infarction Through study completion; average of 1 year
Secondary All-cause mortality Through study completion; average of 1 year
Secondary Systemic thromboembolism Through study completion; average of 1 year
Secondary Major hemorrhage Through study completion; average of 1 year
Secondary Intracranial hemorrhage Through study completion; average of 1 year
Secondary Composite of all stroke, myocardial infarct, systemic thromboembolism or death Through study completion; average of 1 year
Secondary Modified Rankin Scale (mRS) Through study completion; average of 1 year
Secondary Montreal Cognitive Assessment (MOCA) Through study completion; average of 1 year

Sponsors