Last reviewed · How we verify
NCT05083455
Replication of the RECORD1 Anticoagulant Trial in Healthcare Claims Data
trial testing Rivaroxaban in Deep Vein Thrombosis, Pulmonary Embolus in 89,215 participants. Completed in 22 July 2021.
21 July 2021
Quick facts
| Lead sponsor | Brigham and Women's Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 89,215 |
| Start date | 22 September 2020 |
| Primary completion | 21 July 2021 |
| Estimated completion | 22 July 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Rivaroxaban (rivaroxaban) — full drug profile →
- Enoxaparin — full drug profile →
Conditions studied
- Deep Vein Thrombosis, Pulmonary Embolus — all drugs for Deep Vein Thrombosis, Pulmonary Embolus →
Sponsor
Brigham and Women's Hospital
Who can join
Adults 18 to 120, any sex, with Deep Vein Thrombosis, Pulmonary Embolus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A Benchmark, Expand, and Calibration (BenchExCal) Trial Emulation Approach for Using Real-World Evidence to Support Indication Expansions: Design and Process for a Planned Empirical Evaluation.
Wang SV, Russo M, Glynn RJ, Bradley MC, et al · · 2025 · cited 7× · PMID 40067205 · DOI 10.1002/cpt.3621
Verify or expand the search:
- PubMed search for NCT05083455
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Rivaroxaban
Trials testing the same drug.
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- NCT07468448 — Combination Antithrombotic Treatment for Prevention of Recurrent Ischemic Stroke in IntraCranial Atherosclerotic diseaSe · Phase 3 · not yet recruiting
- NCT07318610 — Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease · Phase 3 · not yet recruiting
- NCT07312851 — A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Parti · Phase 1 · recruiting
- NCT06961630 — Post-Operative Biomarker-Guided Precision Medicine For Cardiovascular Risk Reduction · EARLY_PHASE1 · recruiting
Other Brigham and Women's Hospital trials
Trials by the same sponsor.
- NCT07011758 — Dynamic Treatment Regimes for Opioid Use Disorder · Phase 2 · not yet recruiting
- NCT06310018 — Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE · suspended
- NCT04519177 — Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability ... · NA · not yet recruiting
- NCT06355986 — Computerized Decision Support to Prevent Stroke in Atrial Fibrillation · NA · not yet recruiting
- NCT06099275 — Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography · suspended
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 NCT05083455 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Brigham and Women's Hospital
- Last refreshed: 27 July 2023
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/NCT05083455.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing