Medical Need of OAC Reversal

NCT03254147 | Completed Results

• 1 other identifier: 1321-0022
• Study Type: observational
• Target: 53,969
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.

  The number of patients with emergency surgery and major bleeding due to fracture or trauma. Where emergency surgery defined as any surgical procedure (International Classification of Diseases (ICD) 10 code K000-879) performed on the same day as hospital admission with additional claims, major bleeding due to fracture is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any fracture, and major bleeding due to trauma is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any trauma.

  One year

Secondary Outcomes (1)

• The Number of Patients With Cardiac Tamponade and Pericardiocentesis.

  One year

Study Arms (1)

patients prescribed with Oral Anti-coagulants

warfarin and non-vitamin K dependent oral anti-coagulants

Drug: warfarin; Drug: dabigatran; Drug: Apixaban; Drug: Edoxaban; Drug: Rivaroxaban

Interventions

warfarin DRUG

warfarin

patients prescribed with Oral Anti-coagulants

dabigatran DRUG

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

Also known as: PRADAXA, PRAZAXA

patients prescribed with Oral Anti-coagulants

Apixaban DRUG

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

patients prescribed with Oral Anti-coagulants

Edoxaban DRUG

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

patients prescribed with Oral Anti-coagulants

Rivaroxaban DRUG

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

patients prescribed with Oral Anti-coagulants

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

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.

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 32394292 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Warfarin; Dabigatran; apixaban; edoxaban; Rivaroxaban

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyridines; Benzimidazoles; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines

Limitations and Caveats

The findings from this study may not be generalizable to other Japanese population outside of Diagnosis Procedure Combination (DPC) hospitals. All information of each patient is from consent giving DPC hospitals.

Results Point of Contact

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

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

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: August 17, 2017
• First Posted: August 18, 2017
• Study Start: October 15, 2017
• Primary Completion: October 30, 2017
• Study Completion: November 10, 2017
• Last Updated: March 4, 2019
• Results First Posted: March 4, 2019

Record last verified: 2018-10

Locations

JP (1)