An Observational Study on Incidence, Natural History and Treatment Patterns of Venous Thromboembolism in Taiwan

Venous Thromboembolism Clinical Trial

Official title:

An Observational Study on Incidence, Natural History and Treatment Patterns of Venous Thromboembolism in Taiwan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03799016
• Other study ID #: 18787
• Status: Completed
• Start date: December 15, 2016
• Est. completion date: July 1, 2017

Study information

• Verified date: January 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The research question addressed by this study is primarily on the clinical epidemiology of VTE in Taiwan. The study aims to estimate the incidence of VTE and describe natural history of VTE, including long term clinical outcomes in adult Taiwanese population, utilizing population-based electronic health data in Taiwan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104215
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• The source population was the adult population in Taiwan. The legal age for definition as an adult (without additional research ethics review requirement) in Taiwan is 20; therefore all National Health Insurance (NHI) enrollees age 20 or older at any time during the study period were evaluated for VTE.

Exclusion Criteria:

• Person-time before an eligible subject turned 20 were not evaluated.

• Study subjects having inconsistent data on gender and unrealistic date of birth (birth year before 1890 and after 2015) were identified and excluded from the analysis.

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident VTE	Incident VTE cases were those who had a first VTE diagnosis after 1 January 2005 and with at least 5 years of look-back period. Those with a first VTE diagnosis less than 5 years of look-period were considered as undetermined VTE cases.	4 years
Primary	Potential risk factors that occurred before the incident VTE events	Events during the 3 months before the first VTE recurrence will be described. Potential risk factors that will be evaluated include age, gender, and treatment regimen for VTE, adherence to treatment regimen, concomitant medications, and comorbidity. The analysis will be stratified by the nature of the first VTE (provoked and unprovoked). Due to the unknown number of repeated recurrence and complex clinical nature of patients with multiple VTE recurrence, risk factors for multiple recurrences will be evaluated at a less detailed level than that for the first recurrence.	4 years
Primary	Usage patterns of anticoagulants among incident VTE patients were evaluated during incident VTE hospital admission and after discharge		4 years
Primary	All-cause mortality	All deaths before 31 December 2014 among the incident VTE patients were identified through the mortality records. Patients were followed from incident VTE index date, and the patients were censored on 31 December 2014 or termination of NHI coverage without further medical or mortality records. If the patient died during the same hospitalization during the incident VTE, the death date was defined as the discharge date of that specific hospitalization.	4 years
Primary	Major bleeding	Major bleeding (intracranial bleed and gastrointestinal bleed) was the major morbidity of interest and incident VTE patients were followed from incident VTE index date till 31 December 2014, death or termination of NHI coverage without any further medical records. Patients died during the incident VTE hospitalization were excluded for major bleeding follow up.	4 years
Primary	Recurrent VTE	Recurrent VTE events after the incident VTE diagnosis were evaluated during the follow-up period through 31 December 2014 or until the patient died or NHI coverage terminated without any further medical records after the termination. The same VTE operational definitions according to different algorithm in incident VTE were consistently applied in recurrent VTE.	4 years
Primary	Adherence of oral anticoagulant treatment was also evaluated with the calculation of MPR within 6 months and 12 months after discharge.		Up to 6 and 12 month

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