Anticoagulants Comparative Benefit-risk Ratio in Real Life

NCT02785354 | Completed Results

• 1 other identifier: 1160.263
• Study Type: observational
• Target: 103,101
• Locations: 1 country
• Sites: 1

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (6)

• 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).

  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.

  1 year

• Arterial Thrombotic Event

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

  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.

  One year

• Death (All-cause)

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

  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.

  One year

Study Arms (2)

NOAC

New oral anticoagulant groups

VKA

VKA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

New users of NOAC or VKA for NVAF

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1160.263.1 Boehringer Ingelheim Investigational Site

Multiple Locations, France

Location

Related Publications (2)

• Blin P, Dureau-Pournin C, Benichou J, Cottin Y, Mismetti P, Abouelfath A, Lassalle R, Droz C, Moore N. Comparative Real-Life Effectiveness and Safety of Dabigatran or Rivaroxaban vs. Vitamin K Antagonists: A High-Dimensional Propensity Score Matched New Users Cohort Study in the French National Healthcare Data System SNDS. Am J Cardiovasc Drugs. 2020 Feb;20(1):81-103. doi: 10.1007/s40256-019-00359-z.

  PMID: 31254174 DERIVED

• Blin P, Dureau-Pournin C, Cottin Y, Benichou J, Mismetti P, Abouelfath A, Lassalle R, Droz C, Moore N. Comparative Effectiveness and Safety of Standard or Reduced Dose Dabigatran vs. Rivaroxaban in Nonvalvular Atrial Fibrillation. Clin Pharmacol Ther. 2019 Jun;105(6):1439-1455. doi: 10.1002/cpt.1318. Epub 2019 Feb 6.

  PMID: 30499605 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

DOAC \& VKA were prescribed by physicians in their daily practice,with differences for pts \& disease characteristics,including stroke \& bleeding risk factors.To control this pts were 1:1 matched on date of 1st dispensing, gender,age \& hdPS.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: May 27, 2016
• Study Start: March 1, 2016
• Primary Completion: March 4, 2016
• Study Completion: April 5, 2016
• Last Updated: November 2, 2018
• Results First Posted: November 2, 2018

Record last verified: 2018-02

Locations

FR (1)