This trial is active, not recruiting.

Conditions phenprocoumon/vitamin k [va drug interaction], atrial fibrillation, venous thromboembolism
Sponsor Johannes Gutenberg University Mainz
Collaborator Ministry of Health, Rhineland-Palatinate, Germany
Start date January 2011
End date March 2018
Trial size 2500 participants
Trial identifier NCT01809015, UMCM-2010EPI01


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Patients treated with vitamin K antagonists in regular medical care system
Patients with oral anticoagulation therapy in a telemedicine-based coagulation service

Primary Outcomes

Time in therapeutic range
time frame: Assessment during Year 1 after study enrolment
time frame: Assessment at year 1 and 2 after study enrolment
Net clinical benefit
time frame: Assessment at year 1 and 2

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria 1. Age ≥ 18 years of age at study inclusion 2. Written informed consent by patient or legal guardian, if appointed 3. 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 4. 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 1. Contraindication to VKA treatment, e.g. pregnancy or known hypersensitivity 2. Participation in other clinical trial

Additional Information

Official title A Study Programme for the Evaluation of Oral Anticoagulation Therapy With Vitamin K Antagonists
Principal investigator Philipp S Wild, MD, MSc
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Johannes Gutenberg University Mainz.