Management of Major Bleeding Events in Atrial Fibrillation Patients Using Pradaxa

Atrial Fibrillation Clinical Trial

Official title:

A Retrospective Cohort Study With Chart Review to Assess the Management of Major Bleeding Events in NVAF Patients Treated With Dabigatran Etexilate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149303
• Other study ID #: 1160.200
• Status: Completed
• Phase: N/A
• First received: May 19, 2014
• Last updated: April 15, 2015
• Start date: June 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

Purpose:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Hemorrhage

Intervention

Drug:
• Dabigatran 75 mg
PO BID
• Dabigatran 150 mg
PO BID

Locations

Country	Name	City	State
United States	1160.200.03 Boehringer Ingelheim Investigational Site	Austin	Texas
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with index event safety outcomes (ongoing/resolved/deceased)		at time of hospital discharge/release with an average hospital stay of approximately 9 days	No
Primary	Number of patients receiving different types of interventions to stop the index events		until hospital discharge/release with an avergae hospital stay of approximately 9 days	No
Primary	Frequencies of bleeding types and anatomic locations of the index event		at time presentation or hospitalization, day 1	No