Anticoagulation in Intracerebral Hemorrhage (ICH)

Transcript:Anticoagulation in Intracerebral Hemorrhage (ICH):
Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke PreventIon and REcovery Webinar April 22, 2020 NINDS U01 NS106513 NCT03907046 Outline Study Organization Protocol Overview Site Network COVID-19 Impact Assessment Screening Best Practices Planning for Resumption of Enrollment Future Webinars Discussion 22-Apr-2020 ASPIRE Webinar 1 Kevin Sheth, MD Yale University Hooman Kamel, MD Weill Cornell 2 ASPIRE Principal Investigators ASPIRE Webinar 22-Apr-2020 Study Organization Study Organization, continued 3 ASPIRE Webinar 22-Apr-2020 In patients with atrial fibrillation (AF) and CHA2DS2-VASc score ≥ 2, treatment with oral anticoagulants (OAC) is recommended for prevention of stroke/thromboembolism (IA-B evidence). Non-vitamin K oral anticoagulants (NOACs)* are recommended over warfarin for eligible patients with AF (IA evidence) RCTs have shown NOACs to be consistently at least noninferior to warfarin for preventing stroke and systemic embolism with lower risk for serious bleeding. *also called direct oral anticoagulants or DOACs 4 Protocol Overview ASPIRE Webinar 22-Apr-2020 Background ARISTOTLE 5 Randomized, double-blind trial, comparing apixaban (5 mg twice daily) with warfarin (target INR, 2.0-3.0) in patients with AF and at least one additional risk factor for stroke, found apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality. N Engl J Med 2011;365:981-92 22-Apr-2020 ASPIRE Webinar “Anticoagulation and antiplatelet therapy after non-lobar ICH might be considered.” (IIb, B) “The usefulness of dabigatran, rivaroxaban, or apixaban in patients with atrial fibrillation and past ICH is uncertain.” (IIb, C) “An important question to be addressed is the possible role of the newer direct OACs in patients at increased ICH risk and the identification of the subgroup that might derive the greatest benefit from the reduced tendency of these agents to trigger intracranial bleeding.” 6 Current ICH guidelines ASPIRE Webinar 22-Apr-2020 ~20% of ICH survivors have AF but these patients have been excluded from past studies of NOACs. Use of oral anticoagulation is a major clinical dilemma in care of ICH patients with atrial fibrillation. 7 Why ASPIRE? ASPIRE Webinar 22-Apr-2020 ASPIRE Aims 8 Primary: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and AF. Secondary: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale. Tertiary: To assess safety and efficacy of apixaban, compared with aspirin, for individual components of the primary