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

• Head of the study: Professor Philipp Wild, MD, M.Sc.
                            (Principal Investigator)            
                            Professor Thomas Münzel, MD
                            (Co-Principal Investigator)         
• ClinicalTrials.gov - ID-No.: NCT01809015

Summary

The thrombEVAL study program aims to investigate oral anticoagulation therapy (OAC) in daily clinical practice. OAC is regularly applied for the treatment and prevention of thrombotic and embolic complications. In Germany, approximately 900,000 patients are currently treated with OAC. In the future, it is expected that more patients will have to be treated with oral anticoagulants due to the demographic change. Increasing multi-morbidity of the elderly and availability of new therapeutic options are putting high demands on physicians. Comprehensive scientific evidence on OAC with phenprocoumon, which is predominantly used in Germany for OAC, is scarce. The thrombEVAL study program aims to close this gap of knowledge and to provide reliable scientific data to evaluate and improve patient care. The leading state project thrombEVAL (www.gesundheitswirtschaft.rlp.de/massnahmen/landesleitprojekte) is supported by an allied network of academic partners and delegates from the health care system. The study program comprises 3 studies on OAC: evaluation of oral anticoagulation in regular medical care (thrombEVAL1) and in a telemedicine-based coagulation service (thrombEVAL2) and stakeholder analysis of patients and physicians (thrombEVAL3). The study data will help to identify determinants of successful OAC and to develop new concepts for improved and individualized patient care.

• Further information about the thrombEVAL study program you will find on the website: www.thrombEVAL.de

Study Design	thrombEVAL1: Multi-center prospective cohort study
	thrombEVAL2: Single center prospective cohort study
	thrombEVAL3: Single-center, cross-sectional study
Official Title	thrombEVAL – A study program on "medical treatment of patients with oral anticoagulation"
Start of Study	1st quarter 2011
End of Study	1st quarter 2018
Sample Size	thrombEVAL1: 2,011 individuals
	thrombEVAL2: 760 individuals
	thrombEVAL3: approx. 11,700 physicians and 2,000 patients
Study Centers	21
Status	thrombEVAL1: follow-up ongoing (year 1-5 after enrolment via computer-assisted telephone interviews; endpoint validation)
	thrombEVAL2: follow-up accomplished
	thrombEVAL3: accomplished
Steering Committee	Manfred Beutel, Mainz; Christine Espinola-Klein, Mainz; Stavros Konstantinides, Mainz; Karl J Lackner, Mainz; Thomas Münzel, Mainz; Helmut Schinzel, Mainz; Philipp S Wild, Mainz
Study Manager	Jürgen Prochaska