Evaluation of Oral Anticoagulation With Vitamin K Antagonists - The thrombEVAL Study Programme

Completed

• Conditions: Venous Thromboembolism; Atrial Fibrillation; Anticoagulant Antagonists, Vitamin K and Other Coagulants Causing Adverse Effects in Therapeutic Use

• Registration Number: NCT01809015
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

Since decades, oral anticoagulation (OAC) with vitamin K antagonists (VKA) is an established therapy for both prevention and treatment of thromboembolism in daily clinical routine. Increasing life-expectancy, the demographic change and novel oral anticoagulants lead to an increasing complexity of medical therapy. However, data on quality and management of VKA therapy with phenprocoumon in current medical care are limited. Our aim was to investigate the quality of OAC with VKA in current health care and to evaluate the potential for improvements.

The investigator-initiated thrombEVAL study program comprises two cohorts of patients treated with vitamin K antagonists for oral anticoagulation therapy in real-life settings: a multicentre cohort of patients in regular medical care and a multi-local, single centre cohort of patients in a telemedicine-based coagulation service. The study program is expected to enrol a total number of approximately 2,000 to 2,500 patients. Both cohorts build on a detailed clinical assessment of participants and anticoagulation therapy at study enrolment. Subsequently active and passive follow-up investigations are carried out to document and validate complications of the treatment. Primary short-term outcome is the distribution of time in therapeutic range; the primary long-term outcome comprises the composite of stroke, systemic embolism, myocardial infarction, major and clinically-relevant bleeding and death.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2013-03-08
• Study First Submitted QC: 2013-03-08
• Study First Posted: 2013-03-12
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2318

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time in therapeutic range	Assessment during Year 1 after study enrolment	Time in therapeutic range for the International Normalized Ratio as measured by linear interpolation method
Hospitalisation	Assessment at year 1 and 2 after study enrolment	Any Hospitalisation
Net clinical benefit	Assessment at year 1 and 2	Composite of stroke, systemic embolism, pulmonary embolism, myocardial infarction, major and clinically relevant, non-major bleeding and death

Trial Locations

Locations (1)

University Medical Center of the Johannes Gutenberg University Mainz; 🇩🇪 Mainz, Rhineland-Palatinate, Germany