Anticoagulants Comparative Benefit-risk Ratio in Real Life

• 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: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Tracking Information

• First Submitted Date: May 25, 2016
• First Posted Date: May 27, 2016
• Results First Submitted Date: April 4, 2017
• Results First Posted Date: November 2, 2018
• Last Update Posted Date: November 2, 2018
• Actual Study Start Date: March 1, 2016
• Actual Primary Completion Date: March 4, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 5, 2018)

• 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).
• 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.
• 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.
• 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.
• Death (All-cause) [ Time Frame: 1 year ]
  All-cause death (cause of death not available in the database).
• 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.

Original Primary Outcome Measures (submitted: May 25, 2016)

• Major bleeding defined as a hospital-discharge summary with primary diagnosis of bleeding during drug (NOAC or VKA) exposure [ Time Frame: 1 year ]
• Arterial thrombotic event defined as a hospital-discharge summary with primary diagnosis of ischemic or undefined stroke or systemic arterial during drug (NOAC or VKA) exposure embolism [ Time Frame: 1 year ]
• MI defined as a hospital-discharge summary with primary diagnosis of MI or acute coronary syndrome during drug exposure [ Time Frame: 1 year ]
• All-cause death defined as death (cause of death not available in the database) during drug (NOAC or VKA) exposure [ Time Frame: 1 year ]
• Composite criteria of major bleeding, arterial thrombotic events, MI or death during drug (NOAC or VKA) exposure [ Time Frame: 1 year ]

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Anticoagulants Comparative Benefit-risk Ratio in Real Life
• Official Title: Engel 2: REal-life aNticoaGulants Comparative bEnefit-risk in Nonvalvular Atrial fibrilLation (NVAF) in France

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

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: New users of NOAC or VKA for NVAF
• Condition: Atrial Fibrillation
• Intervention: Not Provided

Study Groups/Cohorts

• NOAC
  New oral anticoagulant groups
• VKA
  VKA group

Publications *

• 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. Erratum In: Am J Cardiovasc Drugs. 2022 Jan;22(1):111.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 5, 2018): 103101
• Original Enrollment: Not Provided
• Actual Study Completion Date: April 5, 2016
• Actual Primary Completion Date: March 4, 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02785354
• Other Study ID Numbers: 1160.263
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Boehringer Ingelheim
• Original Responsible Party: Same as current
• Current Study Sponsor: Boehringer Ingelheim
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Boehringer Ingelheim; Boehringer Ingelheim

• PRS Account: Boehringer Ingelheim
• Verification Date: February 2018