Management of Major Bleeding Events in Atrial Fibrillation Patients Using Pradaxa

• ClinicalTrials.gov Identifier: NCT02149303
• Recruitment Status: Completed
• First Posted: May 29, 2014
• Results First Posted: April 4, 2016
• Last Update Posted: April 4, 2016
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Study Description

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.

Condition or disease	Intervention/treatment
Atrial Fibrillation; Hemorrhage	Drug: Dabigatran 75 mg; Drug: Dabigatran 150 mg

Detailed Description:

Purpose:

Study Design

• Study Type: Observational
• Actual Enrollment: 191 participants
• 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
• Study Start Date: June 2014
• Actual Primary Completion Date: March 2015
• Actual Study Completion Date: March 2015

Groups and Cohorts

Group/Cohort	Intervention/treatment
Dabigatran	Drug: Dabigatran 75 mg; PO BID; Drug: Dabigatran 150 mg; PO BID

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   Proportion of subjects with index event safety outcomes (resolved / recovery ongoing / deceased) at the time of their hospital discharge / release.
2. 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 ]
   Proportion of subjects receiving different types of interventions (i.e., medication / procedure and surgery) to manage the index events until their hospital discharge / release.
3. 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 ]

   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%.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

Related Info 

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02149303
• Other Study ID Numbers: 1160.200
• First Posted: May 29, 2014
• Results First Posted: April 4, 2016
• Last Update Posted: April 4, 2016
• Last Verified: March 2016

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