A Study to Compare the Risk of a Major Bleeding in Participants Who Received Blood Thinning Medications Following a Blood Clot

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Venous Thromboembolism (VTE)

Study type: Observational

Funder types: Industry

Identifiers

NCT03521908

CV185-523

Details and patient eligibility

About

A study to compare the risk of a major bleeding in participants who received 2 different blood thinning medications following a blood clot

Enrollment: 35,756 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• An acute-care inpatient encounter with a principal or secondarydiagnosis of VTE, or an ambulatory-care encounter with any diagnosis of VTE
• An outpatient pharmacy claim for apixaban or warfarin during the 30-day period following the index encounter
• Continuous and comprehensive medical/drug coverage for ≥6 months preceding the index encounter

Exclusion criteria

• Evidence of a trial fibrillation/flutter or chemotherapy/radiation therapy for malignancy (other than non-melanoma skin cancer) during 6-month period preceding first receipt of index therapy
• Evidence of VTE(VTE event)during 6-month period preceding index encounter
• Evidence of malignancy (other than non-melanoma skin cancer) during 90-day period preceding first receipt of index therapy

Other protocol defined inclusion/exclusion criteria could apply

Trial design

35,756 participants in 2 patient groups

Participants treated with apixaban

Participants treated with warfarin