Sequential Expansion of Comparative Effectiveness of Anticoagulants

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02081807
First received: March 6, 2014
Last updated: July 9, 2014
Last verified: July 2014

March 6, 2014
July 9, 2014
March 2014
September 2016   (final data collection date for primary outcome measure)
  • Stroke [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Major bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT02081807 on ClinicalTrials.gov Archive Site
  • Stroke or systemic embolism [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Systemic embolism [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Ischemic stroke [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Hemorrhagic stroke [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Stroke uncertain classification [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Major intracranial bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: Yes ]
  • Major extracranial bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: Yes ]
  • Major gastrointestinal bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: Yes ]
  • Transient Ischemic Attack [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Myocardial infarction [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Venous Thromboembolism [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Deep vein thrombosis [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Pulmonary Embolism [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Major upper gastrointestinal bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: Yes ]
  • Major lower gastrointestinal bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: Yes ]
  • Major urogenital bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: Yes ]
  • Other major bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Sequential Expansion of Comparative Effectiveness of Anticoagulants
Sequential Expansion of Comparative Effectiveness of Oral Anticoagulants: A Cohort Study

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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

Atrial Fibrillation
Not Provided
  • Dabigatran
  • Warfarin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120000
September 2016
September 2016   (final data collection date for primary outcome measure)

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.
  • 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
Both
18 Years and older
No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
United States
 
NCT02081807
1160.207
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP