Anticoagulants Comparative Benefit-risk Ratio in Real Life

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT02785354
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The study is an analysis using the French national health insurance database, six months after the beginning of NOAC launch in the NVAF indication.

The aim is to compare the one-year, two-year and three-year benefit-risk (major bleeding, arterial thrombotic events, myocardial infarction (MI), death) between patients starting a NOAC and patients starting a VKA for NVAF in 2013

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-01
• Primary Completion: 2016-03-04
• Study Completion: 2016-04-05
• Study First Submitted: 2016-05-25
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-05-27
• Results First Submitted: 2017-04-04
• Status Verified: 2018-02
• Results First Submitted QC: 2018-03-05
• Last Update Submitted: 2018-03-05
• Results First Posted: 2018-11-02
• Last Update Posted: 2018-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103101

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death (All-cause)	1 year	All-cause death (cause of death not available in the database).
Acute Coronary Syndrome	One year	First hospitalization with primary diagnosis (ICD-10 codes) of: 1. Myocardial infarction (ST-segment elevation Myocardial infarction (STEMI) and non-ST-segment elevation Myocardial infarction(NSTEMI)),; 2. Unstable angina.
Clinically Relevant Bleeding	One year	First hospitalization with primary diagnosis (Tenth Revision codes of the International Classification of Diseases (ICD-10 codes)) of: 1. Hemorrhagic stroke,; 2. Other critical organ or site bleeding,; 3. Other bleeding (gastro-intestinal bleeding, urogenital bleeding and other bleeding subtype).
Major Bleeding	1 year	First hospitalization with primary diagnosis (ICD-10 codes) of: 1. Hemorrhagic stroke,; 2. Other critical organ or site bleeding,; 3. Other bleeding with transfusion, or acute post-hemorrhagic anemia or death during hospital stay.
Arterial Thrombotic Event	1 year	First hospitalization with primary diagnosis (ICD-10 codes) of: 1. Ischemic or undefined stroke,; 2. Systemic arterial embolism.
Composite Criterion (Clinically Relevant Bleeding, Arterial Thrombotic Events, Acute Coronary Syndrome, Death)	One year	First event among clinically relevant bleeding, arterial thrombotic event, acute coronary syndrome, or death defined above.

Trial Locations

Locations (1)

1160.263.1 Boehringer Ingelheim Investigational Site; 🇫🇷 Multiple Locations, France