Anticoagulants Comparative Benefit-risk Ratio in Real Life

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02785354
• Other study ID #: 1160.263
• Status: Completed
• Start date: March 1, 2016
• Est. completion date: April 5, 2016

Study information

• Verified date: February 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103101
• Est. completion date: April 5, 2016
• Est. primary completion date: March 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
France	1160.263.1 Boehringer Ingelheim Investigational Site	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically Relevant Bleeding	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).	One year
Primary	Major Bleeding	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.	1 year
Primary	Arterial Thrombotic Event	First hospitalization with primary diagnosis (ICD-10 codes) of: Ischemic or undefined stroke,; Systemic arterial embolism.	1 year
Primary	Acute Coronary Syndrome	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.	One year
Primary	Death (All-cause)	All-cause death (cause of death not available in the database).	1 year
Primary	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.	One year

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