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

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.

Conditions

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

Sponsors & Collaborators

• Ministry of Health, Rhineland-Palatinate, Germany

  collaborator UNKNOWN

• Ministry of Economics, Rhineland-Palatinate, Germany

  collaborator UNKNOWN

• German Federal Ministry of Education and Research

  collaborator OTHER_GOV

• Boehringer Ingelheim

  collaborator INDUSTRY

• Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

  collaborator INDUSTRY

• Sanofi

  collaborator INDUSTRY

• IMO Institut GmbH

  collaborator UNKNOWN

• PortaVita BV

  collaborator UNKNOWN

• The German Heart Foundation

  collaborator OTHER

• Bayer

  collaborator INDUSTRY

• Johannes Gutenberg University Mainz

  lead OTHER

Principal Investigators

• Philipp S Wild, MD, MSc · University Medical Center of Johannes Gutenberg-University Mainz, Germany

• Thomas F Munzel, MD · University Medical Center of Johannes Gutenberg-University Mainz, Germany

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2018-03-31

Completion

2018-03-31

Countries

• Germany

Study Locations