NASPAF‐ICH.

Trial name or title	Non‐VKA Anticoagulants for Stroke Prevention in Patients with Atrial Fibrillation and Previous IntraCerebral Hemorrhage Study (NASPAF‐ICH)
Methods	Allocation: randomised 2:1 (non‐vitamin K oral antagonist (agent at the discretion of the local investigator) vs aspirin) Blinding: open‐label, blinded adjudication of outcomes Duration: recruitment 24 months, participants will be followed to a common terminate date designated at 6 months following the end of recruitment. Average follow‐up per participant approximately 12 months (range: 12 to 30 months) Design (parallel, other): phase II, open‐label randomised controlled trial Setting: 10 high‐volume stroke centres across Canada Dates: January 2017 to June 2019
Participants	Inclusion criteria 45 years of age or older prior spontaneous intraparenchymal or intraventricular haemorrhage High risk AF (CHADS2 ≥ 2) Exclusion criteria Non‐stroke indication for antiplatelet or anticoagulant therapy Estimated creatinine clearance of < 30 ml per minute Platelet count less than 100,000/mm3 at enrolment or other bleeding diathesis Uncontrollable hypertension with SBP/DBP consistently above 160/100 mmHg Prior symptomatic lobar ICH other than the qualifying event (i.e. ≥ 2 symptomatic lobar ICH) Known hypersensitivity to either aspirin or NOACs Pregnant or breastfeeding
Interventions	Non‐vitamin K oral antagonist (agent at the discretion of the local investigator) vs aspirin 81 mg Strict long‐term blood pressure control to target of < 130/80 mmHg for all participants
Outcomes	Primary outcome measure: the primary feasibility outcome will be recruitment rates Secondary outcomes will be refusal rates and retention rates
Starting date	January 2017
Contact information	Co‐Prinicipal Investigator: Ashkan Shoamanesh, MD, FRCPC Assistant Professor of Medicine (Neurology) Director, Stroke Fellowship Program Marta and Owen Boris Chair in Stroke Research and Care McMaster University / Population Health Research Institute 237 Barton Street East HGH‐DBCVSRI C4‐118 Hamilton, Ontario, L8L 2X2, Canada Email: ashkan.shoamanesh@phri.ca Telephone: (905) 521‐2100 ext 41277 Fax: (905) 577‐1427
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