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OpenTrials
Completed

NCT Number: NCT02785354

Anticoagulants Comparative Benefit-risk Ratio in Real Life

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

1160.263.1 Boehringer Ingelheim Investigational Site

Multiple Locations, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Clinically Relevant Bleeding

    Time frame: One year

    First hospitalization with primary diagnosis (Tenth Revision codes of the International Classification of Diseases (ICD-10 codes)) of:

    • Hemorrhagic stroke,
    • Other critical organ or site bleeding,
    • Other bleeding (gastro-intestinal bleeding, urogenital bleeding and other bleeding subtype).

  2. Major Bleeding

    Time frame: 1 year

    First hospitalization with primary diagnosis (ICD-10 codes) of:

    • Hemorrhagic stroke,
    • Other critical organ or site bleeding,
    • Other bleeding with transfusion, or acute post-hemorrhagic anemia or death during hospital stay.

  3. Arterial Thrombotic Event

    Time frame: 1 year

    First hospitalization with primary diagnosis (ICD-10 codes) of:

    • Ischemic or undefined stroke,
    • Systemic arterial embolism.

  4. Acute Coronary Syndrome

    Time frame: One year

    First hospitalization with primary diagnosis (ICD-10 codes) of:

    • Myocardial infarction (ST-segment elevation Myocardial infarction (STEMI) and non-ST-segment elevation Myocardial infarction(NSTEMI)),
    • Unstable angina.

  5. Death (All-cause)

    Time frame: 1 year

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

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

    Time frame: One year

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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Engel 2: REal-life aNticoaGulants Comparative bEnefit-risk in Nonvalvular Atrial fibrilLation (NVAF) in France

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 27, 2016
Registry last updated
Nov 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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