Comparative Effectiveness of Oral Anticoagulants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01847547
First received: April 18, 2013
Last updated: June 3, 2014
Last verified: April 2014

April 18, 2013
June 3, 2014
April 2013
April 2013   (final data collection date for primary outcome measure)
  • Incidence Rate of Stroke [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
  • Incidence Rate of Major Bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: Yes ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.
  • Stroke [ Time Frame: up to 20 months ] [ Designated as safety issue: No ]
  • Major bleeding [ Time Frame: up to 20 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01847547 on ClinicalTrials.gov Archive Site
  • Incidence Rate of Myocardial Infarction [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
  • Incidence Rate of Venous Thromboembolism [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
  • Incidence Rate of Deep Vein Thrombosis [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
  • Incidence Rate of Pulmonary Embolism [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
  • Incidence Rate of Major Lower Gastrointestinal Bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: Yes ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
  • Incidence Rate of Major Urogenital Bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: Yes ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
  • Incidence Rate of Major Other Bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: Yes ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
  • Incidence Rate of Transient Ischemic Attack [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
  • Incidence Rate of Major Upper Gastrointestinal Bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: Yes ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.
  • Incidence Rate of Stroke or Systemic Embolism [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
  • Incidence Rate of Systemic Embolism [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
  • Incidence Rate of Ischemic Stroke [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
  • Incidence Rate of Hemorrhagic Stroke [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
  • Incidence Rate of Stroke Uncertain Classification [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9.
  • Incidence Rate of Major Intracranial Bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: Yes ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.
  • Incidence Rate of Major Extracranial Bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: Yes ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.
  • Incidence Rate of Major Gastrointestinal Bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: Yes ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.
  • Myocardial infarction [ Time Frame: up to 20 months ] [ Designated as safety issue: No ]
  • Venous thromboembolism [ Time Frame: up to 20 months ] [ Designated as safety issue: No ]
  • Deep vein thrombosis [ Time Frame: up to 20 months ] [ Designated as safety issue: No ]
  • Pulmonary embolism [ Time Frame: up to 20 months ] [ Designated as safety issue: No ]
  • Major lower gastrointestinal bleeding [ Time Frame: up to 20 months ] [ Designated as safety issue: Yes ]
  • Major urogenital bleeding [ Time Frame: up to 20 months ] [ Designated as safety issue: Yes ]
  • Major other bleeding [ Time Frame: up to 20 months ] [ Designated as safety issue: Yes ]
  • Transient ischemic attack [ Time Frame: up to 20 months ] [ Designated as safety issue: No ]
  • Major upper gastrointestinal bleeding [ Time Frame: up to 20 months ] [ Designated as safety issue: Yes ]
  • Stroke or systemic embolism [ Time Frame: up to 20 months ] [ Designated as safety issue: No ]
  • Systemic embolism [ Time Frame: up to 20 months ] [ Designated as safety issue: No ]
  • Ischemic stroke [ Time Frame: up to 20 months ] [ Designated as safety issue: No ]
  • Hemorrhagic stroke [ Time Frame: up to 20 months ] [ Designated as safety issue: No ]
  • Stroke uncertain classification [ Time Frame: up to 20 months ] [ Designated as safety issue: No ]
  • Major intracranial bleeding [ Time Frame: up to 20 months ] [ Designated as safety issue: Yes ]
  • Major extracranial bleeding [ Time Frame: up to 20 months ] [ Designated as safety issue: Yes ]
  • Major gastrointestinal bleeding [ Time Frame: up to 20 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Comparative Effectiveness of Oral Anticoagulants
Comparative Effectiveness of Oral Anticoagulants: A Cohort Study

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.

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.
 
Completed
5982
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01847547
1160.157
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

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