Management of Major Bleeding Events in Atrial Fibrillation Patients Using Pradaxa

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02149303
First received: May 19, 2014
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention
Atrial Fibrillation
Hemorrhage
Drug: Dabigatran 75 mg
Drug: Dabigatran 150 mg

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Cohort Study With Chart Review to Assess the Management of Major Bleeding Events in NVAF Patients Treated With Dabigatran Etexilate

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of patients with index event safety outcomes (ongoing/resolved/deceased) [ Time Frame: at time of hospital discharge/release with an average hospital stay of approximately 9 days ] [ Designated as safety issue: No ]
  • Number of patients receiving different types of interventions to stop the index events [ Time Frame: until hospital discharge/release with an avergae hospital stay of approximately 9 days ] [ Designated as safety issue: No ]
  • Frequencies of bleeding types and anatomic locations of the index event [ Time Frame: at time presentation or hospitalization, day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Dabigatran Drug: Dabigatran 75 mg
PO BID
Drug: Dabigatran 150 mg
PO BID

Detailed Description:

Purpose:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

AF patients with bleeding event using Dabigatran etexilate

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02149303

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
United States, Massachusetts
1160.200.02 Boehringer Ingelheim Investigational Site Not yet recruiting
Boston, Massachusetts, United States
1160.200.06 Boehringer Ingelheim Investigational Site Not yet recruiting
Boston, Massachusetts, United States
United States, New York
1160.200.01 Boehringer Ingelheim Investigational Site Recruiting
Brooklyn, New York, United States
1160.200.05 Boehringer Ingelheim Investigational Site Recruiting
Stony Brook, New York, United States
United States, Texas
1160.200.03 Boehringer Ingelheim Investigational Site Recruiting
Austin, Texas, United States
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02149303     History of Changes
Other Study ID Numbers: 1160.200
Study First Received: May 19, 2014
Last Updated: October 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Hemorrhage
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Dabigatran
Anticoagulants
Antithrombins
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Serine Proteinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014