CompletedNot Applicable

Clinical and Economic Outcomes of Oral Anticoagulants in Non-valvular Atrial Fibrillation

United States466,991 participantsStarted 2016-06-01

Plain-language summary

The primary objectives of this study are to compare the risk of major bleeding and stroke/systemic embolism (SE) events among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating OAC warfarin or apixaban or dabigatran or rivaroxaban treatment.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Had 1 or more pharmacy claim for apixaban or warfarin or dabigatran or rivaroxaban during the identification period (01-Jan-2013 to 30-Sep-2015). The first OAC pharmacy claim date during the identification period will be designated as the index date
✓. Patients 18 years old or older as of the index date
✓. At least 1 diagnosis of atrial fibrillation prior to or on index date, identified by any medical claim
✓. At least 12 months of baseline period prior to index date with continuous enrollment

Exclusion criteria

✕. Evidence of valvular heart disease, transient atrial fibrillation, venous thromboembolism during the 12-month baseline period or on the index date
✕. Evidence of pregnancy during the study period
✕. Had a pharmacy claim for warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 12-month baseline period
✕. Had more than 1 oral anticoagulant claim on the index date

What they're measuring

Time to first major bleeding event

Timeframe: Up to 33 months

Time to first stroke/systemic embolism (SE) event

Timeframe: Up to 33 months

Trial details

NCT IDNCT03087487

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-02-26

View on ClinicalTrials.gov More Non-Valvular Atrial Fibrillation trials