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NCT03254147

Medical Need of OAC Reversal

Completed Results posted Last updated 4 March 2019
What this trial tests

trial testing warfarin in Atrial Fibrillation in 53,969 participants. Completed in 10 November 2017.

Timeline
15 October 2017
Primary endpoint
30 October 2017
10 November 2017

Quick facts

Lead sponsorBoehringer Ingelheim
StatusCompleted
Study typeOBSERVATIONAL
Enrollment53,969
Start date15 October 2017
Primary completion30 October 2017
Estimated completion10 November 2017
Sites1 location across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma. Primary · One year

The number of patients with emergency surgery and major bleeding due to fracture or trauma. Where emergency surgery defined as any surgical procedure (International Classification of Diseases (ICD) 10 code K000-879) performed on the same day as hospital admission with additional claims, major bleeding due to fracture is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any fracture, and major bleeding due to trauma is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any trauma.

Age <=64
GroupValue95% CI
Patients Prescribed With Non-warfarin Oral Anti Coagulants14
Age 65-74
GroupValue95% CI
Patients Prescribed With Non-warfarin Oral Anti Coagulants35
Age >=75
GroupValue95% CI
Patients Prescribed With Non-warfarin Oral Anti Coagulants84
The Number of Patients With Cardiac Tamponade and Pericardiocentesis. Secondary · One year

The number of patients with cardiac tamponade and pericardiocentesis. Cardiac tamponade diagnosis (ICD 10 code 4200001) on the same or next day as catheter ablation or percutaneous coronary intervention (PCI), Pericardiocentesis (Medical Data Vision (MDV) procedure code 140010510) on the same or next day as catheter ablation or PCI.

GroupValue95% CI
Patients Prescribed With Non-warfarin Oral Anti Coagulants1

Sponsor's own description

This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Incidence Rates of Bleeding and Emergency Surgery Due to Trauma or Fracture Among Japanese Patients with Non-valvular Atrial Fibrillation Receiving Oral Anticoagulation Therapy.
    Yasaka M, Yokota H, Suzuki M, Yamane T, et al · · 2020 · cited 3× · PMID 32394292 · DOI 10.1007/s40119-020-00171-w

Verify or expand the search:

Other trials of warfarin

Trials testing the same drug.

Other recruiting trials for Atrial Fibrillation

Currently open trials in the same condition.

Other Boehringer Ingelheim trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT03254147.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing