# AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenicstroke (ARCADIA)

> **NIH NIH U01** · COLUMBIA UNIVERSITY HEALTH SCIENCES · 2021 · $1,790,846

## Abstract

In one-third of strokes, a definite cause cannot be established. This proposal is for a clinical trial
involving patients with a stroke of unknown cause who also have atrial cardiopathy, or abnormal changes in
the atrial tissue of the heart. The goal is to compare two different blood-thinning treatments to determine which
best prevents recurrent stroke. Under the prevailing clinical paradigm, it is thought that atrial fibrillation—a
common disorder of heart rhythm—is required for blood clots to form in the heart's left atrium, from where they
can embolize to the brain and cause stroke. Therefore, unless atrial fibrillation is apparent, patients do not
receive the types of blood-thinning drugs that best prevent embolic stroke. However, recent research indicates
that embolization from the left atrium can occur when there are abnormal changes to atrial tissue and function
even before there is atrial fibrillation. These abnormal changes—a condition referred to as atrial cardiopathy—
may explain many of the strokes that are currently of unknown cause. Since blood-thinning treatment with an
anticoagulant drug such as apixaban has already proven more effective than standard aspirin therapy for
preventing stroke from atrial fibrillation, the parallels between atrial fibrillation and atrial cardiopathy suggest
that apixaban may also be more effective than aspirin for stroke prevention in patients with atrial cardiopathy
and no atrial fibrillation. This application is for a multicenter, biomarker-driven, randomized, double-blind,
active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial
cardiopathy and a recent stroke of unknown cause by current criteria. Atrial cardiopathy will be defined as one
or more of the following biomarkers: P-wave terminal force in electrocardiogram lead V1 >5,000 µV*ms, left
atrial size index ≥3.0 cm/m2 on echocardiogram, and serum amino terminal pro-B-type natriuretic peptide >250
pg/mL. Standard heart-rhythm monitoring will be performed before enrollment to exclude as thoroughly as
possible those patients with atrial fibrillation. Eleven hundred patients will be recruited over 2.5 years at 120
sites in the NINDS StrokeNet consortium. Patients will be followed for a minimum of 1.5 years and a maximum
of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of major
hemorrhage and intracranial hemorrhage. Specific Aim 1 will test the hypothesis that apixaban is superior to
aspirin for the prevention of recurrent stroke in patients with atrial cardiopathy. Validation of this hypothesis
would have immediate implications for preventing recurrent stroke by identifying a new group of stroke patients
who benefit from anticoagulant therapy. Specific Aim 2 will test the hypothesis that the efficacy of apixaban
over aspirin increases with the severity of atrial cardiopathy. Validation of this hypothesis would help establish
atrial cardiopathy as a strok...

## Key facts

- **NIH application ID:** 10241235
- **Project number:** 5U01NS095869-04
- **Recipient organization:** COLUMBIA UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** Joseph Paul Broderick
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,790,846
- **Award type:** 5
- **Project period:** 2017-05-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10241235

## Citation

> US National Institutes of Health, RePORTER application 10241235, AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenicstroke (ARCADIA) (5U01NS095869-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10241235. Licensed CC0.

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