NCT03907046

Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Aim: 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 atrial fibrillation (AF). Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale.

Detailed description

ASPIRE is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of anticoagulation, compared with aspirin, in patients with a recent ICH and non-valvular AF. Seven hundred patients will be enrolled over 3.5 years and followed for study outcomes for a minimum of 12 months and maximum of 36 months. The primary efficacy outcome is any stroke (hemorrhagic or ischemic) or death from any cause. The secondary efficacy outcome is the change in the modified Rankin Scale score. Recruitment will take place at sites coordinated through the NIH/NINDS StrokeNet.

Conditions

• Intracerebral Hemorrhage
• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Apixaban	Apixaban is an oral anticoagulant of the Factor Xa inhibitor class.
DRUG	Aspirin	Aspirin is an oral antiplatelet drug.

Timeline

• Start date: 2020-01-28
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2019-04-08
• Last updated: 2026-02-12

Locations

184 sites across 1 country: United States

Regulatory

• FDA-regulated drug study