Management of Gastrointestinal and Urogenital (GI/GU) Bleedings in Atrial Fibrillation Patients Using Pradaxa

Boehringer Ingelheim

Status: Completed

Conditions: Atrial Fibrillation

Study type: Observational

Funder types: Industry

Identifiers

NCT02022020

1160.162

Details and patient eligibility

About

This study is being conducted to collect data on the management of gastrointestinal and urogenital bleeding events occurring in patients with atrial fibrillation taking dabigatran etexilate.

Full description

Purpose:

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >=18 years of age;
• Confirmed diagnosis of Atrial Fibrillation (AF);
• Documentation that the patient had an acute GI and/or GU bleeding event and having taken at least one dose of dabigatran prior to the event.

Exclusion criteria

• Confirmed diagnosis of valvular AF (VAF);
• Documentation that the patient was taking dabigatran with other oral anticoagulant;
• Documentation of the patient receiving thrombolytic therapy prior to the event;
• Documentation that the patient was enrolled in an investigational clinical trial at the time of the event;
• Medical record was not available.

Trial design

220 participants in 1 patient group

Group 1