Clinical trial NCT03254147: Medical Need of OAC Reversal
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-08-18
Enrollment: 53969
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.
timeFrame: One year
Secondary outcomes:
measure: The Number of Patients With Cardiac Tamponade and Pericardiocentesis.
timeFrame: One year
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Nippon Boehringer Ingelheim Co., Ltd.
Study officials:
References:
citation: 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.