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

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.

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Key information

Conditions

Anticoagulant Antagonists, Vitamin K and Other Coagulants Causing Adverse Effects in Therapeutic Use Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Embolism and Thrombosis Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center of the Johannes Gutenberg University Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 18 years of age at study inclusion
Written informed consent by patient or legal guardian, if appointed
Cohort A: Pretreatment with oral anticoagulation therapy with vitamin K antagonists (VKA) for at least 4 months in regular medical care including patients with self-management of oral anticoagulation therapy
Cohort B: Indication for oral anticoagulation therapy with VKA for at least 3 months (both drug-naive and -experienced patients) at enrolment including patients with self-management of oral anticoagulation therapy.

Exclusion criteria

Contraindication to VKA treatment, e.g. pregnancy or known hypersensitivity
Participation in other clinical trial

Treatment and study plan

Primary outcomes

Time in therapeutic range

Time frame: Assessment during Year 1 after study enrolment

Time in therapeutic range for the International Normalized Ratio as measured by linear interpolation method
Hospitalisation

Time frame: Assessment at year 1 and 2 after study enrolment

Any Hospitalisation
Net clinical benefit

Time frame: Assessment at year 1 and 2

Composite of stroke, systemic embolism, pulmonary embolism, myocardial infarction, major and clinically relevant, non-major bleeding and death

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Collaborators

Bayer
Boehringer Ingelheim
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
German Federal Ministry of Education and Research
IMO Institut GmbH
Ministry of Economics, Rhineland-Palatinate, Germany
Ministry of Health, Rhineland-Palatinate, Germany
PortaVita BV
Sanofi
The German Heart Foundation

Registry information

Official study title

A Study Programme for the Evaluation of Oral Anticoagulation Therapy With Vitamin K Antagonists

Acronym: thrombEVAL

Important dates

Study start: 2011
Primary completion: 2018
Study completion: 2018
First posted: Mar 12, 2013
Registry last updated: Aug 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed