Clinical trial NCT02998905: NOACs for Stroke Prevention in Patients With Atrial Fibrillation and Previous ICH
Official title: Non-Vitamin K Antagonist Oral Anticoagulants for Stroke Prevention in Patients With Atrial Fibrillation and Previous Intracerebral Hemorrhage Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Intracerebral Hemorrhage
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: Through study completion; ~ 30 months
measure: Composite of ischemic stroke and recurrent intracerebral hemorrhage
timeFrame: Through study completion; average of 1 year
Secondary outcomes:
measure: Refusal rate
timeFrame: Through study completion; average of 1 year
measure: Retention rate
timeFrame: Through study completion; average of 1 year
measure: Ischemic stroke
timeFrame: Through study completion; average of 1 year
measure: Intracerebral hemorrhage
timeFrame: Through study completion; average of 1 year
measure: Fatal stroke
timeFrame: Through study completion; average of 1 year
measure: Myocardial infarction
timeFrame: Through study completion; average of 1 year
measure: All-cause mortality
timeFrame: Through study completion; average of 1 year
measure: Systemic thromboembolism
timeFrame: Through study completion; average of 1 year
measure: Major hemorrhage
timeFrame: Through study completion; average of 1 year
measure: Intracranial hemorrhage
timeFrame: Through study completion; average of 1 year
measure: Composite of all stroke, myocardial infarct, systemic thromboembolism or death
timeFrame: Through study completion; average of 1 year
measure: Modified Rankin Scale (mRS)
timeFrame: Through study completion; average of 1 year
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: Through study completion; average of 1 year
Other outcomes:
measure: Weighted net clinical benefit
timeFrame: Through study completion; average of 1 year
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver Coastal Health Research Institute
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Montréal
country: Canada
facility: Hopital Notre-Dame du CHUM
state: Quebec
Study officials:
affiliation: Population Health Research Institute
name: Ashkan Shoamanesh, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: