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

Study Overview
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Brief Summary
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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.

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

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A: Regular medical care<br>Patients treated with vitamin K antagonists in regular medical care system | |
| Cohort B: Coagulation service<br>Patients with oral anticoagulation therapy in a telemedicine-based coagulation service | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Anticoagulation, Regular Medical Care, Coagulation Service, Vitamin-K Antagonists, Quality of therapy, Atrial fibrillation, Venous thromboembolism, Bypass surgery, Prosthetic heart valve