Sequential Expansion of Comparative Effectiveness of Anticoagulants

NCT02081807 | Completed Results

• 1 other identifier: 1160.207
• Study Type: observational
• Target: 221,228
• Locations: 1 country
• Sites: 1

Brief Summary

This cohort study is the sequential expansion of the comparative effectiveness study of oral anticoagulants and plans to identify initiators of oral anticoagulants using electronic claims data from a commercial insurance database to quantify associations between anticoagulant choice (warfarin and dabigatran) and the occurrence of selected outcomes in patients with non-valvular atrial fibrillation at risk for stroke.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Stroke (Hemorrhagic, Ischemic, or Stroke of Uncertain Classification)

  The rate of overall stroke (hemorrhagic, ischemic or stroke of uncertain classification ) in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: As primary International Classification of Diseases, Ninth Revision (ICD-9) discharge diagnosis (Dx): 431.x Intracerebral hemorrhage (ICH), 433.x1 Occlusion and stenosis of precerebral arteries with cerebral infarction, 434.x1 Occlusion and stenosis of cerebral arteries with cerebral infarction, 436.x Acute, but ill-defined cerebrovascular events.

  From October 2010 to September 2015 (the study period)

• Major Bleeding

  The rate of major bleeding (Major intracranial bleeding and major extracranial bleed ) in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. For outcome definitions please refer the descriptions section of outcome 8 (major intracranial bleeding) and outcome 9 (major extracranial bleeding).

  From October 2010 to September 2015 (the study period)

Secondary Outcomes (17)

• Stroke or Systemic Embolism

  From October 2010 to September 2015 (the study period)

• Systemic Embolism

  From October 2010 to September 2015 (the study period)

• Ischemic Stroke

  From October 2010 to September 2015 (the study period)

• Hemorrhagic Stroke

  From October 2010 to September 2015 (the study period)

• Stroke Uncertain Classification

  From October 2010 to September 2015 (the study period)

Study Arms (2)

Dabigatran

Warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years of age and older with non-valvular AF initiating oral anticoagulation therapy

You may qualify if:

• A recorded diagnosis of atrial fibrillation.
• Initiation of anticoagulant medication (dabigatran (or other new oral anticoagulants as they become available) or warfarin).
• At least 18 years of age on the date of anticoagulant initiation.
• Congestive Heart Failure, Hypertension, Age \> 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease, Age 65-74, Sex Category (CHA2DS2-VASc) score at least 1

You may not qualify if:

• Patients with missing or ambiguous age or sex information.
• Patients with evidence of valvular disease.
• Patients with less than 12 months enrolment preceding the date of anticoagulant initiation
• Patients with a dispensing of any oral anticoagulant during the 12 months preceding the date of anticoagulant initiation
• Patients with a nursing home stay during the 12 months preceding the date of anticoagulant initiation

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 7, 2014
• Study Start: March 7, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: October 2, 2019
• Results First Posted: October 2, 2019

Record last verified: 2019-09

Locations

US (1)