Medical Need of OAC Reversal

NCT ID: NCT03254147

Last Updated: 2019-03-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53969 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-15

Study Completion Date

2017-11-10

Brief Summary

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This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF

Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients prescribed with Oral Anti-coagulants

warfarin and non-vitamin K dependent oral anti-coagulants

warfarin

Intervention Type DRUG

warfarin

dabigatran

Intervention Type DRUG

Non-vitamin K dependent oral anti-coagulants (NOACs)

Apixaban

Intervention Type DRUG

Non-vitamin K dependent oral anti-coagulants (NOACs)

Edoxaban

Intervention Type DRUG

Non-vitamin K dependent oral anti-coagulants (NOACs)

Rivaroxaban

Intervention Type DRUG

Non-vitamin K dependent oral anti-coagulants (NOACs)

Interventions

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warfarin

warfarin

Intervention Type DRUG

dabigatran

Non-vitamin K dependent oral anti-coagulants (NOACs)

Intervention Type DRUG

Apixaban

Non-vitamin K dependent oral anti-coagulants (NOACs)

Intervention Type DRUG

Edoxaban

Non-vitamin K dependent oral anti-coagulants (NOACs)

Intervention Type DRUG

Rivaroxaban

Non-vitamin K dependent oral anti-coagulants (NOACs)

Intervention Type DRUG

Other Intervention Names

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PRADAXA, PRAZAXA

Eligibility Criteria

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Inclusion Criteria

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

* Prescribed dabigatran, rivaroxaban, apixaban, edoxaban or warfarin
* Patients 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, , Japan

Site Status

Countries

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Japan

References

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Yasaka M, Yokota H, Suzuki M, Yamane T, Ono Y. Incidence Rates of Bleeding and Emergency Surgery Due to Trauma or Fracture Among Japanese Patients with Non-valvular Atrial Fibrillation Receiving Oral Anticoagulation Therapy. Cardiol Ther. 2020 Jun;9(1):189-199. doi: 10.1007/s40119-020-00171-w. Epub 2020 May 11.

Reference Type DERIVED
PMID: 32394292 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1321-0022

Identifier Type: -

Identifier Source: org_study_id

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