NCT03087474

Brief Summary

In a population of patients with venous thromboembolism and treated with oral anticoagulants (OAC) in routine clinical practice in Denmark this study will describe patients treated with each OAC

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89,383

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2018

Completed
Last Updated

July 11, 2018

Status Verified

July 1, 2018

Enrollment Period

2.1 years

First QC Date

March 2, 2017

Last Update Submit

July 9, 2018

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (8)

  • Hospitalization rate in VKA patients for VTE

    Hospitalization rate for first-time Venous thromboembolism (VTE) in Vitamin K antagonist (VKA) patients

    Approximately 180 months

  • VTE hospitalization rate in VKA patients by sex

    Approximately 180 months

  • VTE hospitalization rate in VKA patients by age

    Approximately 180 months

  • Hospitalization rate in NOAC patients for VTE

    Hospitalization rate for first-time venous thromboembolism in nonvitamin K antagonist oral anticoagulants (NOAC) patients

    Approximately 180 months

  • VTE hospitalization rate in NOAC patients by sex

    Approximately 180 months

  • VTE hospitalization rate in NOAC patients by age

    Approximately 180 months

  • Duration of Treatment in NOAC patients

    Approximately 180 months

  • Duration of treatment in VKA patients

    Approximately 180 months

Study Arms (2)

VKA patients

Vitamin K antagonist (VKA) patients

Other: Non-Interventional

NOAC patients

nonvitamin K antagonist oral anticoagulants (NOAC) patients

Other: Non-Interventional

Interventions

Non-InterventionalOTHER

Non-Interventional

NOAC patientsVKA patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The Danish National Patient Registry (DNPR), covering all Danish hospitals, will be used to identify first-time and recurrent VTE cases diagnosed from 01-Jan-2006 through 31-Dec-2015.

You may qualify if:

  • All patients ≥ 18 years diagnosed with incident VTE at Danish public hospitals from 2006 through 2015
  • First-time (index) VTE will be defined as an in- or out-patient diagnosis of DVT or PE among patients redeeming a prescription for anticoagulant drugs within 30 days after index date

You may not qualify if:

  • \. In the analyses on type and duration of anticoagulant use, Patients with cancer will be excluded as they typically receive low molecular heparin directly from the hospital and their use of anticoagulants can therefore not be captured by redeemed prescriptions at pharmacies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2017

First Posted

March 22, 2017

Study Start

December 4, 2015

Primary Completion

December 31, 2017

Study Completion

June 28, 2018

Last Updated

July 11, 2018

Record last verified: 2018-07