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Management of Major Bleeding Events in Atrial Fibrillation Patients Using Pradaxa

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02149303
First received: May 19, 2014
Last updated: March 3, 2016
Last verified: March 2016
  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:
  • Proportion of Subjects With Index Event Safety Outcomes (Resolved / Recovery Ongoing / Deceased) at the Time of Their Hospital Discharge / Release. [ Time Frame: From the time of presentation / admission to an ED / ER or hospitalization through all in-hospital referrals until discharge (between 20 August 2014 (the date of the first data entry) and 4 March 2015 (the date of data entry closure)); Up to 196 days ] [ Designated as safety issue: No ]
    Proportion of subjects with index event safety outcomes (resolved / recovery ongoing / deceased) at the time of their hospital discharge / release.

  • Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release [ Time Frame: From the time of presentation / admission to an ED / ER or hospitalization through all in-hospital referrals until discharge (between 20 August 2014 (the date of the first data entry) and 4 March 2015 (the date of data entry closure)); Up to 196 days ] [ Designated as safety issue: No ]
    Proportion of subjects receiving different types of interventions (i.e., medication / procedure and surgery) to manage the index events until their hospital discharge / release.

  • Index Event Characteristics (i.e. Type of Bleeding and Anatomic Locations of the Index Event) at the Time of the ED / ER Presentation or Hospitalization [ Time Frame: From the time of presentation / admission to an ED / ER or hospitalization through all in-hospital referrals until discharge (between 20 August 2014 (the date of the first data entry) and 4 March 2015 (the date of data entry closure)); Up to 196 days ] [ Designated as safety issue: No ]

    Proportion of Index events by anatomic location and type are presented. The categories of Unknown and Other presented below correspond to, Unknown: Unknown location of bleeding met the criteria for major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH).

    Other: Other types of bleeding represent a combined category of all other locations of bleeding whose incidence was <1.7%.



Enrollment: 191
Study Start Date: June 2014
Study Completion Date: March 2015
Primary Completion Date: March 2015 (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   (Adult, Senior)
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

Locations
United States, Massachusetts
1160.200.02 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
1160.200.06 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
United States, New York
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
United States, Texas
1160.200.03 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02149303     History of Changes
Other Study ID Numbers: 1160.200 
Study First Received: May 19, 2014
Results First Received: March 3, 2016
Last Updated: March 3, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 23, 2016