Evaluation of Oral Anticoagulation With Vitamin K Antagonists - The thrombEVAL Study Programme (thrombEVAL)
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| ClinicalTrials.gov Identifier: NCT01809015 |
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Recruitment Status :
Completed
First Posted : March 12, 2013
Last Update Posted : August 24, 2018
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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.
| Condition or disease |
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| Anticoagulant Antagonists, Vitamin K and Other Coagulants Causing Adverse Effects in Therapeutic Use Atrial Fibrillation Venous Thromboembolism |
| Study Type : | Observational |
| Actual Enrollment : | 2318 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | A Study Programme for the Evaluation of Oral Anticoagulation Therapy With Vitamin K Antagonists |
| Actual Study Start Date : | January 2011 |
| Actual Primary Completion Date : | March 2018 |
| Actual Study Completion Date : | March 2018 |
| Group/Cohort |
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Cohort A: Regular medical care
Patients treated with vitamin K antagonists in regular medical care system
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Cohort B: Coagulation service
Patients with oral anticoagulation therapy in a telemedicine-based coagulation service
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- Time in therapeutic range [ Time Frame: Assessment during Year 1 after study enrolment ]Time in therapeutic range for the International Normalized Ratio as measured by linear interpolation method
- Hospitalisation [ Time Frame: Assessment at year 1 and 2 after study enrolment ]Any Hospitalisation
- Net clinical benefit [ Time Frame: Assessment at year 1 and 2 ]Composite of stroke, systemic embolism, pulmonary embolism, myocardial infarction, major and clinically relevant, non-major bleeding and death
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
In cohort A, patients of regular medical care are enrolled in the area of Rhineland-Palatinate, Germany. Treatment and management of oral anticoagulation therapy with vitamin K antagonists is performed within primary (ambulatory) care system.
In cohort B, patients are treated with oral anticoagulation in a specialized telemedicine-based coagulation service in the area of Rhinehesse, Germany.
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809015
| Germany | |
| University Medical Center of the Johannes Gutenberg University Mainz | |
| Mainz, Rhineland-Palatinate, Germany, 55131 | |
| Principal Investigator: | Philipp S Wild, MD, MSc | University Medical Center of Johannes Gutenberg-University Mainz, Germany | |
| Principal Investigator: | Thomas F Munzel, MD | University Medical Center of Johannes Gutenberg-University Mainz, Germany |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Philipp Wild, MD, MSc, Univ.-Prof. Dr. med. Philipp Wild, MSc, Johannes Gutenberg University Mainz |
| ClinicalTrials.gov Identifier: | NCT01809015 |
| Other Study ID Numbers: |
UMCM-2010EPI01 |
| First Posted: | March 12, 2013 Key Record Dates |
| Last Update Posted: | August 24, 2018 |
| Last Verified: | August 2018 |
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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 |
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Atrial Fibrillation Thromboembolism Venous Thromboembolism Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Pathologic Processes Embolism and Thrombosis Vascular Diseases |