Management of Major Bleeding Events in Atrial Fibrillation Patients Using Pradaxa

Completed

Conditions studied: Atrial Fibrillation, Hemorrhage

In brief

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

Key facts

Study ID

NCT02149303

Run by

Boehringer Ingelheim

People needed

191

Starts

2014-06-01

Expected to finish

2015-03-01

Last updated by the study team

2016-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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