Clinical trial NCT02081807: Sequential Expansion of Comparative Effectiveness of Anticoagulants
Official title: Sequential Expansion of 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: 2014-03-07
Enrollment: 221228
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 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.


Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* 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

Primary outcomes:
measure: Stroke (Hemorrhagic, Ischemic, or Stroke of Uncertain Classification)
timeFrame: From October 2010 to September 2015 (the study period)
measure: Major Bleeding
timeFrame: From October 2010 to September 2015 (the study period)
Secondary outcomes:
measure: Stroke or Systemic Embolism
timeFrame: From October 2010 to September 2015 (the study period)
measure: Systemic Embolism
timeFrame: From October 2010 to September 2015 (the study period)
measure: Ischemic Stroke
timeFrame: From October 2010 to September 2015 (the study period)
measure: Hemorrhagic Stroke
timeFrame: From October 2010 to September 2015 (the study period)
measure: Stroke Uncertain Classification
timeFrame: From October 2010 to September 2015 (the study period)
measure: Major Intracranial Bleeding
timeFrame: From October 2010 to September 2015 (the study period)
measure: Major Extra-cranial Bleeding
timeFrame: From October 2010 to September 2015 (the study period)
measure: Major Gastrointestinal (GI) Bleeding
timeFrame: From October 2010 to September 2015 (the study period)
measure: Major Upper Gastrointestinal Bleeding
timeFrame: From October 2010 to September 2015 (the study period)
measure: Major Lower Gastrointestinal Bleeding
timeFrame: From October 2010 to September 2015 (the study period)
measure: Major Urogenital Bleeding
timeFrame: From October 2010 to September 2015 (the study period)
measure: Other Major Bleeding
timeFrame: From October 2010 to September 2015 (the study period)
measure: Transient Ischemic Attack (TIA)
timeFrame: From October 2010 to September 2015 (the study period)
measure: Myocardial Infarction (MI)
timeFrame: From October 2010 to September 2015 (the study period)
measure: Venous Thromboembolism (VTE)
timeFrame: From October 2010 to September 2015 (the study period)
measure: Deep Vein Thrombosis (DVT)
timeFrame: From October 2010 to September 2015 (the study period)
measure: Pulmonary Embolism (PE)
timeFrame: From October 2010 to September 2015 (the study period)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: