Comparative Effectiveness of Oral Anticoagulants

NCT01847547 | Completed Results

• 1 other identifier: 1160.157
• Study Type: observational
• Target: 5,982
• Locations: 0 countries
• Sites: N/A

Brief Summary

This cohort study 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)

• Incidence Rate of Stroke

  Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  From treatment initiation until end of follow-up; up to 20 months

• Incidence Rate of Major Bleeding

  Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.

  From treatment initiation until end of follow-up; up to 20 months

Secondary Outcomes (17)

• Incidence Rate of Myocardial Infarction

  From treatment initiation until end of follow-up; up to 20 months

• Incidence Rate of Venous Thromboembolism

  From treatment initiation until end of follow-up; up to 20 months

• Incidence Rate of Deep Vein Thrombosis

  From treatment initiation until end of follow-up; up to 20 months

• Incidence Rate of Pulmonary Embolism

  From treatment initiation until end of follow-up; up to 20 months

• Incidence Rate of Major Lower Gastrointestinal Bleeding

  From treatment initiation until end of follow-up; up to 20 months

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 (AF).
• Initiation of anticoagulant medication (dabigatran or warfarin).
• At least 18 years of age on the date of anticoagulant initiation CHA2DS2-VASc-Score \>=1

You may not qualify if:

• Patients with missing or ambiguous age or sex information
• Patients with documented evidence of valvular disease
• Patients with less than 12 months enrolment in the UnitedHealth Research Database preceding the date of anticoagulant initiation
• Patients with prior use of any oral anticoagulant

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

These first data are limited by small sample size, short follow up, few events resulting in wide confidence intervals. No comparative conclusions are possible. After the feasibility analysis future analysis will increase patient numbers and follow up

Results Point of Contact

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

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: May 7, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 6, 2014
• Results First Posted: May 19, 2014

Record last verified: 2014-04