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NCT04249401: REATTAIN
Study to Gather Information About the Safety of Oral Anticoagulation Drugs and How Well These Drugs Work in Real World for Patients With Non-valvular Atrial Fibrillation (Irregularly Heart Beats Which is Not Caused by a Heart Valve Problem)
trial testing Rivaroxaban (Xarelto) in Atrial Fibrillation in 134,897 participants. Completed in 30 September 2023.
30 September 2023
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 134,897 |
| Start date | 1 March 2020 |
| Primary completion | 30 September 2023 |
| Estimated completion | 30 September 2023 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- Rivaroxaban (Xarelto) — full drug profile →
- Apixaban (apixaban) — full drug profile →
- Dabigatran (DABIGATRAN) — full drug profile →
- Warfarin (warfarin) — full drug profile →
Conditions studied
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
Sponsor
Bayer — full company profile →
Who can join
18 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Oral anticoagulant (OAC) treatment with either vitamin K antagonists (VKAs) or non-vitamin K antagonist oral anticoagulants (NOACs) is essential in patients with atrial fibrillation for the prevention of stroke or systemic embolism (SE) a condition that happens when a blood clot forms elsewhere in the body and travels through the blood stream to plug another vessel. While there are significant number of real-world publications on the use and outcomes of NOACs for stroke prevention, evidence from routine clinical practice on the use and outcomes of reduced doses of NOACs is scarce. By evaluating routine clinical practice data from national registers in Denmark, Finland, Norway and Sweden, researchers want to gather information about the safety and how well reduced doses of NOACs work in patients with irregularly heartbeats which are not caused by a heart valve problem (non-valvular atrial fibrillation, NVAF). As a primary aim of this study, treatment with low doses of NOACs (Xarelto \[generic name rivaroxaban\], Eliquis \[generic name apixaban\] or Pradaxa \[generic name dabigatran\]) will be compared with VKAs (warfarin) in Nordic patients with NVAF to assess the occurrence of stroke and systemic embolism \[effectiveness\]) and intracranial hemorrhage a type of bleeding that occurs inside the skull \[safety\]).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04249401
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Rivaroxaban (Xarelto)
Trials testing the same drug.
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Other recruiting trials for Atrial Fibrillation
Currently open trials in the same condition.
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- NCT07388108 — Atrial Dyssynchrony to Predict Arrhythmias in the Postoperative Setting of Cardiovascular Surgery. · recruiting
- NCT07428967 — AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function · NA · recruiting
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Other Bayer trials
Trials by the same sponsor.
- NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
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- NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
- NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04249401 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 1 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04249401.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing