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

Johannes Gutenberg University (JGU)

Status: Completed

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01809015

UMCM-2010EPI01

Details and patient eligibility

About

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.

Enrollment: 2,318 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

2,318 participants in 2 patient groups

Cohort A: Regular medical care

Description:

Patients treated with vitamin K antagonists in regular medical care system

Cohort B: Coagulation service

Description:

Patients with oral anticoagulation therapy in a telemedicine-based coagulation service