# Anticoagulation in ICH Survivors for Prevention and Recovery (ASPIRE)

> **NIH NIH U01** · YALE UNIVERSITY · 2023 · $4,270,266

## Abstract

Atrial fibrillation, the most common heart-rhythm disorder, increases the risk of ischemic stroke by 3- to
5-fold. Anticoagulant therapy has been proven to prevent 60-80% of ischemic strokes that would otherwise
occur from atrial fibrillation. Patients with a history of intracerebral hemorrhage have been excluded from
clinical trials of anticoagulation in patients with atrial fibrillation. Whether to use anticoagulation in these
patients represents a major knowledge gap and clinical dilemma. Many clinicians fear that the proven benefit of
anticoagulation in preventing ischemic stroke will be offset by an increase in hemorrhagic stroke. Preliminary
data from multicenter studies indicate that, in patients with atrial fibrillation and recent intracerebral
hemorrhage, anticoagulation is associated with a decreased risk of ischemic stroke and overall mortality with
no offsetting increase in the burden of recurrent hemorrhagic stroke. These pilot data also suggest that
anticoagulation is associated with better long-term functional outcomes. Although these data are compelling,
they are observational findings and subject to confounding and bias. In clinical practice, about one-third of
patients with intracerebral hemorrhage and atrial fibrillation receive anticoagulation and the remainder receive
antiplatelet therapy such as aspirin. Current clinical guidelines call for randomized, blinded clinical trials to
provide high-quality evidence to determine the best treatment. The argument for a clinical trial is made more
compelling by the advent of apixaban, a relatively new oral anticoagulant drug, which was found to have similar
bleeding risks as aspirin in a recent head-to-head trial. This application is for a multicenter, double-blinded,
randomized clinical trial of apixaban versus aspirin in patients with atrial fibrillation and a recent intracerebral
hemorrhage. Seven hundred patients will be recruited and followed for 1 to 3 years at 125 sites in NINDS
StrokeNet. The aim of the study will be to test the hypothesis that apixaban improves outcomes compared to
aspirin. The primary outcome will be any stroke (ischemic or hemorrhagic) or death. This composite outcome
addresses both efficacy and safety, and represents a clinically meaningful endpoint often used in stroke
prevention trials. The secondary endpoint will be functional status, as measured by the modified Rankin Scale
score. This secondary endpoint will be used to test the hypothesis that apixaban not only reduces stroke
recurrence but also the severity of any strokes that do occur. If confirmed, this novel finding would provide an
important patient-centered context for the primary trial results. This proposal offers an opportunity to improve
the outcomes of patients with intracerebral hemorrhage by focusing on their brain health both in the acute
setting and over the long term. The impact of this study is that its successful completion, regardless of the
direction of its results, would immediatel...

## Key facts

- **NIH application ID:** 10159987
- **Project number:** 5U01NS106513-03
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** Hooman Kamel
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $4,270,266
- **Award type:** 5
- **Project period:** 2019-07-01 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10159987

## Citation

> US National Institutes of Health, RePORTER application 10159987, Anticoagulation in ICH Survivors for Prevention and Recovery (ASPIRE) (5U01NS106513-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10159987. Licensed CC0.

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