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Medical Need of OAC Reversal

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ClinicalTrials.gov Identifier: NCT03254147
Recruitment Status : Completed
First Posted : August 18, 2017
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: warfarin Drug: dabigatran Drug: Apixaban Drug: Edoxaban Drug: Rivaroxaban

Detailed Description:
This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF, the incidence rates of emergency surgery, major bleeding due to trauma, and major bleeding due to fracture, overall and stratified by age (<64, 65-74, >75). The secondary objective is to estimate the overall and age stratified incidence of cardiac tamponade and peri-cardiocentesis.

Study Design

Study Type : Observational
Actual Enrollment : 12000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Medical Need of Oral Anti-coagulant Reversal in Japan: Epidemiological Assessment of Head Trauma, Fracture, and Emergency Surgery Using Large Scale Claims Database (Please Note That This Study Contains no Patients Treated With Idarucizumab Although the Study Number Begins With 1321; the Study Contains Only Patients Treated With OACs, Namely Warfarin, Dabigatran, Edoxaban, Apixaban, Rivaroxaban, Edoxaban)
Actual Study Start Date : October 15, 2017
Primary Completion Date : October 30, 2017
Study Completion Date : November 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Warfarin
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
patients prescribed with Oral Anti-Coagulants
warfarin and non-vitamin K dependent oral anti-coagulants
Drug: warfarin
warfarin
Drug: dabigatran
Non-vitamin K dependent oral anti-coagulatns (NOACs)
Drug: Apixaban
Non-vitamin K dependent oral anti-coagulatns (NOACs)
Drug: Edoxaban
Non-vitamin K dependent oral anti-coagulatns (NOACs)
Drug: Rivaroxaban
Non-vitamin K dependent oral anti-coagulatns (NOACs)


Outcome Measures

Primary Outcome Measures :
  1. incidence rates of emergency surgery, major bleeding associated with trauma and fracture [ Time Frame: one year ]

Secondary Outcome Measures :
  1. incidence rates of pericardial effusion and cardiac tamponade [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patients with atrial fibrillation contained in the Medical Data Vision (MDV) database which is a Japanese, nationwide claims data containing approximately 16 million patients cumulatively. The data cut is between March 2011 to June 2016, and the patients in the MDV database are those who have visited DPC hospitals (diagnostic procedure combination, a lump-sum payment system based on disease diagnosis to be treated similar to Medicare/Medicaid in the USA) hospitals which provide acute in-patient, as well as outpatient care.
Criteria

Inclusion Criteria:

->18 year old non-valvular atrial fibrillation (NVAF) patients

  • Prescribed dabigatran, rivaroxaban, apixaban, edoxaban or warfarin
  • atients with confirmed date of initiation of OACs
  • Patients with a minimum of 6 months of enrolment data prior to index date
  • Has an index date between 14th of March 2011 to 30 June, 2016

Exclusion Criteria:

  • Patients receiving two or more oral anti-coagulants at the same time at index date
  • Patients with prescriptions of index treatment in the 6 months prior to index date
  • Patients without enrolment period of at least six month in the database
Contacts and Locations

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): NCT03254147


Locations
Japan
Nippon Boehringer Ingelheim Co., Ltd.
Tokyo, Japan
Sponsors and Collaborators
Boehringer Ingelheim
More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03254147     History of Changes
Other Study ID Numbers: 1321-0022
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Apixaban
Edoxaban
Warfarin
Rivaroxaban
Dabigatran
Anticoagulants
Coagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action