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

• Status: Completed
• Trial end date: 2020-02-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Population Health Research Institute
• Treatments: Aspirin

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