Observational studyInternational journal of stroke : official journal of the International Stroke Society2023
Early or late initiation of dabigatran versus vitamin-K-antagonists in acute ischemic stroke or TIA: The PRODAST study.
Observational study in International journal of stroke : official journal of the International Stroke Society, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.
- Pooled it
- Pooled it
- When to Start Oral Anticoagulant Therapy Post-Stroke: From Common to Rare Conundrums.Current neurology and neuroscience reports · 2026Review
- Early Anticoagulation in Acute Ischemic Stroke With Atrial Fibrillation.Journal of stroke · 2026Review
- Early Versus Late Anticoagulation for Acute Ischemic Stroke in Atrial Fibrillation: A Systematic Review and Meta-Analysis of 17,380 Patients.Neurology international · 2025Review
- Ischemic stroke prevention in patients with atrial fibrillation and a recent ischemic stroke, TIA, or intracranial hemorrhage: A World Stroke Organization (WSO) scientific statement.International journal of stroke : official journal of the International Stroke Society · 2025Review
- Prior Anticoagulation and Risk of Hemorrhagic Transformation in Acute Stroke: A Post Hoc Analysis of the PRODAST Study.Journal of the American Heart Association · 2025Observational
- [Focus neurological intensive care medicine 2023/2024 : Summary of selected studies in intensive medical care].Die Anaesthesiologie · 2025Article
- Efficacy and safety of oral factor Xa inhibitors versus vitamin-K antagonists in the early phase after acute ischemic stroke or TIA in the real-world setting: The PRODAST study.European stroke journal · 2024Observational
- Reversal and resumption of anticoagulants in patients with anticoagulant-associated intracerebral hemorrhage.European journal of medical research · 2024Review
- [What is confirmed in the treatment of ischemic stroke].Innere Medizin (Heidelberg, Germany) · 2023Review
Corrections and comments
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Authors and funding
16 authors at 12 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe optimal timing of initiating or resuming anticoagulation after acute ischemic stroke (AIS) or transient ischemic attack (TIA) in patients with atrial fibrillation (AF) is debated. Dabigatran, a non-vitamin K oral anticoagulant (NOAC), has shown superiority against vitamin K antagonists (VKA) regarding hemorrhagic complications.
aimsIn this registry study, we investigated the initiation of dabigatran in the early phase after AIS or TIA.
methodsPRODAST (Prospective Record of the Use of Dabigatran in Patients with Acute Stroke or TIA) is a prospective, multicenter, observational, post-authorization safety study. We recruited 10,039 patients at 86 German stroke units between July 2015 and November 2020. A total of 3,312 patients were treated with dabigatran or VKA and were eligible for the analysis that investigates risks for major hemorrhagic events within 3 months after early (⩽ 7 days) or late (> 7 days) initiation of dabigatran or VKA initiated at any time. Further endpoints were recurrent stroke, ischemic stroke, TIA, systemic embolism, myocardial infarction, death, and a composite endpoint of stroke, systemic embolism, life-threatening bleeding and death.
resultsMajor bleeding event rates per 10,000 treatment days ranged from 1.9 for late administered dabigatran to 4.9 for VKA. Early or late initiation of dabigatran was associated with a lower hazard for major hemorrhages as compared to VKA use. The difference was pronounced for intracranial hemorrhages with an adjusted hazard ratio (HR) of 0.47 (95% confidence interval (CI): 0.10-2.21) for early dabigatran use versus VKA use and an adjusted HR of 0.09 (95% CI: 0.00-13.11) for late dabigatran use versus VKA use. No differences were found between early initiation of dabigatran versus VKA use regarding ischemic endpoints.
conclusionsThe early application of dabigatran appears to be safer than VKA administered at any time point with regards to the risk of hemorrhagic complications and in particular for intracranial hemorrhage. This result, however, must be interpreted with caution in view of the low precision of the estimate.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.