Clinical trial NCT01847547: Comparative Effectiveness of Oral Anticoagulants
Official title: Comparative Effectiveness of Oral Anticoagulants: A Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-05-07
Enrollment: 5982
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18 years of age and older with non-valvular AF initiating oral anticoagulation therapy

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.


Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* 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

Primary outcomes:
measure: Incidence Rate of Stroke
timeFrame: From treatment initiation until end of follow-up; up to 20 months
measure: Incidence Rate of Major Bleeding
timeFrame: From treatment initiation until end of follow-up; up to 20 months
Secondary outcomes:
measure: Incidence Rate of Myocardial Infarction
timeFrame: From treatment initiation until end of follow-up; up to 20 months
measure: Incidence Rate of Venous Thromboembolism
timeFrame: From treatment initiation until end of follow-up; up to 20 months
measure: Incidence Rate of Deep Vein Thrombosis
timeFrame: From treatment initiation until end of follow-up; up to 20 months
measure: Incidence Rate of Pulmonary Embolism
timeFrame: From treatment initiation until end of follow-up; up to 20 months
measure: Incidence Rate of Major Lower Gastrointestinal Bleeding
timeFrame: From treatment initiation until end of follow-up; up to 20 months
measure: Incidence Rate of Major Urogenital Bleeding
timeFrame: From treatment initiation until end of follow-up; up to 20 months
measure: Incidence Rate of Major Other Bleeding
timeFrame: From treatment initiation until end of follow-up; up to 20 months
measure: Incidence Rate of Transient Ischemic Attack
timeFrame: From treatment initiation until end of follow-up; up to 20 months
measure: Incidence Rate of Major Upper Gastrointestinal Bleeding
timeFrame: From treatment initiation until end of follow-up; up to 20 months
measure: Incidence Rate of Stroke or Systemic Embolism
timeFrame: From treatment initiation until end of follow-up; up to 20 months
measure: Incidence Rate of Systemic Embolism
timeFrame: From treatment initiation until end of follow-up; up to 20 months
measure: Incidence Rate of Ischemic Stroke
timeFrame: From treatment initiation until end of follow-up; up to 20 months
measure: Incidence Rate of Hemorrhagic Stroke
timeFrame: From treatment initiation until end of follow-up; up to 20 months
measure: Incidence Rate of Stroke Uncertain Classification
timeFrame: From treatment initiation until end of follow-up; up to 20 months
measure: Incidence Rate of Major Intracranial Bleeding
timeFrame: From treatment initiation until end of follow-up; up to 20 months
measure: Incidence Rate of Major Extracranial Bleeding
timeFrame: From treatment initiation until end of follow-up; up to 20 months
measure: Incidence Rate of Major Gastrointestinal Bleeding
timeFrame: From treatment initiation until end of follow-up; up to 20 months
Other outcomes:
Locations:
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: