Management of Major Bleeding Events in Atrial Fibrillation Patients Using Pradaxa

NCT ID: NCT02149303

Last Updated: 2016-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 191 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-03-31

Brief Summary

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

Detailed Description

Purpose:

Conditions

Atrial Fibrillation; Hemorrhage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Dabigatran

Dabigatran 75 mg

Intervention Type: DRUG

PO BID

Dabigatran 150 mg

Intervention Type: DRUG

PO BID

Interventions

Dabigatran 75 mg

PO BID

Intervention Type: DRUG

Dabigatran 150 mg

PO BID

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Greater than or equal to 18 years of age;
• Confirmed diagnosis of non valvular atrial fibrillation (NVAF) (Diagnosis of AF is considered confirmed if there is medical chart documentation that the patient has atrial fibrillation or AF or the ICD-9 or ICD-10 code for AF is documented);
• NVAF is defined as follows: nonvalvular atrial fibrillation is restricted to cases in which the rhythm disturbance occurs in the absence of rheumatic mitral stenosis or a prosthetic heart valve.
• Documentation that the patient presented to an emergency department/emergency room (ED/ER) for a major bleeding event (index event);
• Major bleeding is defined by International Society on Thrombosis and Haemostasis (ISTH) as:
• fatal bleeding and/or
• symptomatic bleeding in a critical area/organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or
• bleeding causing a fall in hemoglobin of 20g per liter or more, or leading to transfusion of 2 or more units of whole blood or red blood cells
• Documentation that the index event occurred in a patient who reported having taken at least one dose of dabigatran within the 5 days prior to the index event.

Exclusion Criteria

• Confirmed diagnosis of valvular AF (Diagnosis of valvular AF is considered confirmed if there is medical chart documentation that the patient has valvular AF or VAF. In the absence of documentation to indicate whether the patient has non-valvular or valvular AF,);
• Documentation that the patient was taking dabigatran with a concomitant anticoagulant (contemporaneous parenteral anticoagulant or another oral anticoagulant) within 72 hours of the index event;
• The concomitant administration of antiplatelet medications prior to the onset of the index event is not exclusionary;
• Documentation of the patient receiving thrombolytic therapy within 48 hours of the onset of the index event;
• Documentation that the patient was enrolled in an interventional investigational or other BI observational clinical trial at the time of the onset of the index event;
• Medical record was not retrievable, was missing or empty.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1160.200.02 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

1160.200.06 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

1160.200.01 Boehringer Ingelheim Investigational Site

Brooklyn, New York, United States

1160.200.05 Boehringer Ingelheim Investigational Site

Stony Brook, New York, United States

1160.200.03 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Countries

United States

Other Identifiers

1160.200

Identifier Type: -

Identifier Source: org_study_id