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Anticoagulants Comparative Benefit-risk Ratio in Real Life

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ClinicalTrials.gov Identifier: NCT02785354
Recruitment Status : Completed
First Posted : May 27, 2016
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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


Condition or disease
Atrial Fibrillation

Study Design
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Study Type : Observational
Actual Enrollment : 103101 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Engel 2: REal-life aNticoaGulants Comparative bEnefit-risk in Nonvalvular Atrial fibrilLation (NVAF) in France
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : March 4, 2016
Actual Study Completion Date : April 5, 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
NOAC
New oral anticoagulant groups
VKA
VKA group


Outcome Measures
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Primary Outcome Measures :
  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:

    1. Hemorrhagic stroke,
    2. Other critical organ or site bleeding,
    3. 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:

    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.

  3. Arterial Thrombotic Event [ Time Frame: 1 year ]

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

    1. Ischemic or undefined stroke,
    2. Systemic arterial embolism.

  4. Acute Coronary Syndrome [ Time Frame: 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.

  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
New users of NOAC or VKA for NVAF
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02785354


Locations
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France
1160.263.1 Boehringer Ingelheim Investigational Site
Multiple Locations, France
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02785354    
Other Study ID Numbers: 1160.263
First Posted: May 27, 2016    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes