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

Atrial Fibrillation Clinical Trial

— thrombEVAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01809015
• Other study ID #: UMCM-2010EPI01
• Status: Completed
• Start date: January 2011
• Est. completion date: March 2018

Study information

• Verified date: August 2018
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2318
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	University Medical Center of the Johannes Gutenberg University Mainz	Mainz	Rhineland-Palatinate

Sponsors (11)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz	Bayer, Boehringer Ingelheim, Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company, German Federal Ministry of Education and Research, IMO Institut GmbH, Ministry of Economics, Rhineland-Palatinate, Germany, Ministry of Health, Rhineland-Palatinate, Germany, PortaVita BV, Sanofi, The German Heart Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Hospitalisation	Any Hospitalisation	Assessment at year 1 and 2 after study enrolment
Primary	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

External Links

•   Study information homepage