Comparative Effectiveness of Oral Anticoagulants

Atrial Fibrillation Clinical Trial

Official title:

Comparative Effectiveness of Oral Anticoagulants: A Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847547
• Other study ID #: 1160.157
• Status: Completed
• Phase: N/A
• First received: April 18, 2013
• Last updated: June 3, 2014
• Start date: April 2013
• Est. completion date: April 2013

Study information

• Verified date: April 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany:
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5982
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	Incidence Rate of Myocardial Infarction	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	No
Secondary	Incidence Rate of Venous Thromboembolism	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	No
Secondary	Incidence Rate of Deep Vein Thrombosis	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	No
Secondary	Incidence Rate of Pulmonary Embolism	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	No
Secondary	Incidence Rate of Major Lower Gastrointestinal Bleeding	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	Yes
Secondary	Incidence Rate of Major Urogenital Bleeding	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	Yes
Secondary	Incidence Rate of Major Other Bleeding	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	Yes
Secondary	Incidence Rate of Transient Ischemic Attack	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	No
Secondary	Incidence Rate of Major Upper Gastrointestinal 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	Yes
Secondary	Incidence Rate of Stroke or Systemic Embolism	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	No
Secondary	Incidence Rate of Systemic Embolism	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	No
Secondary	Incidence Rate of Ischemic 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	No
Secondary	Incidence Rate of Hemorrhagic 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	No
Secondary	Incidence Rate of Stroke Uncertain Classification	Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9.	From treatment initiation until end of follow-up; up to 20 months	No
Secondary	Incidence Rate of Major Intracranial Bleeding	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	Yes
Secondary	Incidence Rate of Major Extracranial 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	Yes
Secondary	Incidence Rate of Major Gastrointestinal 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	Yes

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