Abstract | RATIONALE: AIMS: SAMPLE SIZE ESTIMATE: 1100 participants. METHODS AND DESIGN:
Biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial conducted at 120 U.S. centers participating in NIH StrokeNet. POPULATION STUDIED: Patients ≥ 45 years of age with embolic stroke of undetermined source and evidence of atrial cardiopathy, defined as ≥ 1 of the following markers: P-wave terminal force >5000 µV × ms in ECG lead V1, serum NT-proBNP > 250 pg/mL, and left atrial diameter index ≥ 3 cm/m2 on echocardiogram. Exclusion criteria include any atrial fibrillation, a definite indication or contraindication to antiplatelet or anticoagulant therapy, or a clinically significant bleeding diathesis. Intervention: Apixaban 5 mg twice daily versus aspirin 81 mg once daily. Analysis: Survival analysis and the log-rank test will be used to compare treatment groups according to the intention-to-treat principle, including participants who require open-label anticoagulation for newly detected atrial fibrillation. STUDY OUTCOMES: DISCUSSION:
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Authors | Hooman Kamel, W T Longstreth Jr, David L Tirschwell, Richard A Kronmal, Joseph P Broderick, Yuko Y Palesch, Caitlyn Meinzer, Catherine Dillon, Irene Ewing, Judith A Spilker, Marco R Di Tullio, Eldad A Hod, Elsayed Z Soliman, Seemant Chaturvedi, Claudia S Moy, Scott Janis, Mitchell Sv Elkind |
Journal | International journal of stroke : official journal of the International Stroke Society
(Int J Stroke)
Vol. 14
Issue 2
Pg. 207-214
(02 2019)
ISSN: 1747-4949 [Electronic] United States |
PMID | 30196789
(Publication Type: Clinical Trial Protocol, Journal Article, Research Support, N.I.H., Extramural)
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Chemical References |
- apixaban
- Aspirin
- Biomarkers
- Pyrazoles
- Pyridones
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Topics |
- Aged
- Aged, 80 and over
- Humans
- Middle Aged
- Aspirin
(therapeutic use)
- Biomarkers
- Cardiomyopathies
(drug therapy, mortality)
- Electrocardiography
- Ischemia
(drug therapy, mortality)
- Pyrazoles
(therapeutic use)
- Pyridones
(therapeutic use)
- Recurrence
- Stroke
(drug therapy, mortality)
- Survival Analysis
- Treatment Outcome
- United States
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