Anticoagulants Comparative Benefit-risk Ratio in Real Life

Boehringer Ingelheim103,101 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

103,101

Conditions

Atrial Fibrillation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: Patients with NVAF with a first reimbursed dispensation of Pradaxa®, Xarelto®, or VKA in 2013, with no other identified indication for anticoagulation; Without any VKA or NOAC (Pradaxa®, Xarelto®, or Eliquis®) reimbursed dispensation for the last 3 years before the first reimbursed dispensation of Pradaxa®, Xarelto®, or VKA Exclusion criteria: None

Locations (1)

1160.263.1 Boehringer Ingelheim Investigational Site

Multiple Locations, France

Outcomes

Primary Outcomes

Clinically Relevant Bleeding

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).

Time frame: One year

Major Bleeding

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.

Time frame: 1 year

Arterial Thrombotic Event

First hospitalization with primary diagnosis (ICD-10 codes) of: 1. Ischemic or undefined stroke, 2. Systemic arterial embolism.

Time frame: 1 year

Acute Coronary Syndrome

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.

Time frame: One year

Death (All-cause)

All-cause death (cause of death not available in the database).

Time frame: 1 year

Composite Criterion (Clinically Relevant Bleeding, Arterial Thrombotic Events, Acute Coronary Syndrome, Death)

First event among clinically relevant bleeding, arterial thrombotic event, acute coronary syndrome, or death defined above.

Time frame: One year

Data from ClinicalTrials.gov

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