Anticoagulant Antagonists, Vitamin K and Other Coagulants Causing Adverse Effects in Therapeutic UsethrombEVALNCT01809015
Evaluation of Oral Anticoagulation With Vitamin K Antagonists - The thrombEVAL Study Programme
An observational study of Anticoagulant Antagonists, Vitamin K and Other Coagulants Causing Adverse Effects in Therapeutic Use and Atrial Fibrillation, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulant Antagonists, Vitamin K and Other Coagulants Causing Adverse Effects in Therapeutic Use, Atrial Fibrillation, Venous Thromboembolism
- Type of treatment
- Pill or oral medicine
- How many people
- 2,318 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Contraindication to VKA treatment, e.g. pregnancy or known hypersensitivity
- Participation in other clinical trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center of the Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: A Study Programme for the Evaluation of Oral Anticoagulation Therapy With Vitamin K Antagonists
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.
- Conditions
- Anticoagulant Antagonists, Vitamin K and Other Coagulants Causing Adverse Effects in Therapeutic Use, Atrial Fibrillation, Venous Thromboembolism
- Keywords
- Oral Anticoagulation, Regular Medical Care, Coagulation Service, Vitamin-K Antagonists, Quality of therapy, Atrial fibrillation, Venous thromboembolism, Bypass surgery, Prosthetic heart valve
- Medical subject headings
- Atrial Fibrillation, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Regular medical care | Patients treated with vitamin K antagonists in regular medical care system | |
| Cohort B: Coagulation service | Patients with oral anticoagulation therapy in a telemedicine-based coagulation service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in therapeutic range
Time in therapeutic range for the International Normalized Ratio as measured by linear interpolation method
Measured: Assessment during Year 1 after study enrolment
Hospitalisation
Any Hospitalisation
Measured: 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
Measured: Assessment at year 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2013 (estimated)
- Study startJan 2011
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Anticoagulant Antagonists, Vitamin K and Other Coagulants Causing Adverse Effects in Therapeutic UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Rhineland-Palatinate, Germany, Ministry of Economics, Rhineland-Palatinate, Germany, German Federal Ministry of Education and Research, Boehringer Ingelheim, Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company, Sanofi, IMO Institut GmbH, PortaVita BV, The German Heart Foundation, Bayer
- Responsible party
- Principal investigator, Philipp Wild, MD, MSc, Johannes Gutenberg University Mainz
- Investigators
- Philipp S Wild, MD, MSc, Principal investigator, University Medical Center of Johannes Gutenberg-University Mainz, GermanyThomas F Munzel, MD, Principal investigator, University Medical Center of Johannes Gutenberg-University Mainz, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809015
- Sponsor's protocol ID
- UMCM-2010EPI01
- Acronym
- thrombEVAL
- Status last verified
- Aug 2018
- First submitted
- 8 Mar 2013
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Keller K, Prochaska JH, Coldewey M, Gobel S, Schmitt VH, Hahad O, Ullmann A, Nagler M, Lamparter H, Espinola-Klein C, Munzel T, Wild PS. Atherosclerosis and Its Impact on the Outcomes of Patients with Deep Venous Thrombosis. Life (Basel). 2022 May 14;12(5):734. doi: 10.3390/life12050734.
PubMed 35629401Eggebrecht L, Ludolph P, Gobel S, Panova-Noeva M, Arnold N, Nagler M, Bickel C, Lauterbach M, Hardt R, Cate HT, Lackner KJ, Espinola-Klein C, Munzel T, Prochaska JH, Wild PS. Cost saving analysis of specialized, eHealth-based management of patients receiving oral anticoagulation therapy: Results from the thrombEVAL study. Sci Rep. 2021 Jan 28;11(1):2577. doi: 10.1038/s41598-021-82076-9.
PubMed 33510343Michal M, Eggebrecht L, Gobel S, Panova-Noeva M, Nagler M, Arnold N, Lauterbach M, Bickel C, Wiltink J, Beutel ME, Munzel T, Wild PS, Prochaska JH. The relevance of depressive symptoms for the outcome of patients receiving vitamin K antagonists: results from the thrombEVAL cohort study. Eur Heart J Cardiovasc Pharmacother. 2021 Jul 23;7(4):271-279. doi: 10.1093/ehjcvp/pvz085.
PubMed 31922545Prochaska JH, Gobel S, Nagler M, Knopfler T, Eggebrecht L, Lamparter H, Panova-Noeva M, Keller K, Coldewey M, Bickel C, Lauterbach M, Hardt R, Espinola-Klein C, Ten Cate H, Rostock T, Munzel T, Wild PS. Sustained atrial fibrillation increases the risk of anticoagulation-related bleeding in heart failure. Clin Res Cardiol. 2018 Dec;107(12):1170-1179. doi: 10.1007/s00392-018-1293-4. Epub 2018 Jun 9.
PubMed 29948286Prochaska JH, Gobel S, Keller K, Coldewey M, Ullmann A, Lamparter H, Schulz A, Schinzel H, Bickel C, Lauterbach M, Michal M, Hardt R, Binder H, Espinola-Klein C, Lackner KJ, Ten Cate H, Munzel T, Wild PS. e-Health-based management of patients receiving oral anticoagulation therapy: results from the observational thrombEVAL study. J Thromb Haemost. 2017 Jul;15(7):1375-1385. doi: 10.1111/jth.13727. Epub 2017 Jun 6.
PubMed 28457013Keller K, Prochaska JH, Coldewey M, Gobel S, Ullmann A, Junger C, Lamparter H, Ariza L, Bickel C, Lauterbach M, Konstantinides S, Rostock T, Munzel T, Wild PS. History of deep vein thrombosis is a discriminator for concomitant atrial fibrillation in pulmonary embolism. Thromb Res. 2015 Nov;136(5):899-906. doi: 10.1016/j.thromres.2015.08.024. Epub 2015 Sep 3.
PubMed 26376038Prochaska JH, Gobel S, Keller K, Coldewey M, Ullmann A, Lamparter H, Junger C, Al-Bayati Z, Baer C, Walter U, Bickel C, ten Cate H, Munzel T, Wild PS. Quality of oral anticoagulation with phenprocoumon in regular medical care and its potential for improvement in a telemedicine-based coagulation service--results from the prospective, multi-center, observational cohort study thrombEVAL. BMC Med. 2015 Jan 23;13:14. doi: 10.1186/s12916-015-0268-9.
PubMed 25616558Prochaska JH, Coldewey M, Gobel S, Keller K, Hendelmeier M, Konstantinides S, Munzel T, Wild PS; thrombEVAL Study Group. Evaluation of oral anticoagulation therapy: rationale and design of the thrombEVAL study programme. Eur J Prev Cardiol. 2015 May;22(5):622-8. doi: 10.1177/2047487314527852. Epub 2014 Mar 31.
PubMed 24685605
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Programme for the Evaluation of Oral Anticoagulation Therapy With Vitamin K Antagonists
- ClinicalTrials.gov ID
- NCT01809015
- Acronym / sponsor ID
- thrombEVAL / UMCM-2010EPI01
- Conditions
- Anticoagulant Antagonists, Vitamin K and Other Coagulants Causing Adverse Effects in Therapeutic Use, Atrial Fibrillation, Venous Thromboembolism
- Keywords
- Oral Anticoagulation, Regular Medical Care, Coagulation Service, Vitamin-K Antagonists, Quality of therapy, Atrial fibrillation, Venous thromboembolism, Bypass surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,318 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- Ministry of Health, Rhineland-Palatinate, Germany, Ministry of Economics, Rhineland-Palatinate, Germany, German Federal Ministry of Education and Research, Boehringer Ingelheim, Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company, Sanofi, IMO Institut GmbH, PortaVita BV, The German Heart Foundation, Bayer
- Study start
- Jan 2011 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 12 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Regular medical care | – | –Patients treated with vitamin K antagonists in regular medical care system |
| Cohort B: Coagulation service | – | –Patients with oral anticoagulation therapy in a telemedicine-based coagulation service |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Contraindication to VKA treatment, e.g. pregnancy or known hypersensitivity
- Participation in other clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Derived from this study: PubMed 35629401Keller K, Prochaska JH, Coldewey M, Gobel S, Schmitt VH, Hahad O, Ullmann A, Nagler M, Lamparter H, Espinola-Klein C, Munzel T, Wild PS. Atherosclerosis and Its Impact on the Outcomes of Patients with Deep Venous Thrombosis. Life (Basel). 2022 May 14;12(5):734. doi: 10.3390/life12050734.
- Derived from this study: PubMed 33510343Eggebrecht L, Ludolph P, Gobel S, Panova-Noeva M, Arnold N, Nagler M, Bickel C, Lauterbach M, Hardt R, Cate HT, Lackner KJ, Espinola-Klein C, Munzel T, Prochaska JH, Wild PS. Cost saving analysis of specialized, eHealth-based management of patients receiving oral anticoagulation therapy: Results from the thrombEVAL study. Sci Rep. 2021 Jan 28;11(1):2577. doi: 10.1038/s41598-021-82076-9.
- Derived from this study: PubMed 31922545Michal M, Eggebrecht L, Gobel S, Panova-Noeva M, Nagler M, Arnold N, Lauterbach M, Bickel C, Wiltink J, Beutel ME, Munzel T, Wild PS, Prochaska JH. The relevance of depressive symptoms for the outcome of patients receiving vitamin K antagonists: results from the thrombEVAL cohort study. Eur Heart J Cardiovasc Pharmacother. 2021 Jul 23;7(4):271-279. doi: 10.1093/ehjcvp/pvz085.
- Derived from this study: PubMed 29948286Prochaska JH, Gobel S, Nagler M, Knopfler T, Eggebrecht L, Lamparter H, Panova-Noeva M, Keller K, Coldewey M, Bickel C, Lauterbach M, Hardt R, Espinola-Klein C, Ten Cate H, Rostock T, Munzel T, Wild PS. Sustained atrial fibrillation increases the risk of anticoagulation-related bleeding in heart failure. Clin Res Cardiol. 2018 Dec;107(12):1170-1179. doi: 10.1007/s00392-018-1293-4. Epub 2018 Jun 9.
- Derived from this study: PubMed 28457013Prochaska JH, Gobel S, Keller K, Coldewey M, Ullmann A, Lamparter H, Schulz A, Schinzel H, Bickel C, Lauterbach M, Michal M, Hardt R, Binder H, Espinola-Klein C, Lackner KJ, Ten Cate H, Munzel T, Wild PS. e-Health-based management of patients receiving oral anticoagulation therapy: results from the observational thrombEVAL study. J Thromb Haemost. 2017 Jul;15(7):1375-1385. doi: 10.1111/jth.13727. Epub 2017 Jun 6.
- Derived from this study: PubMed 26376038Keller K, Prochaska JH, Coldewey M, Gobel S, Ullmann A, Junger C, Lamparter H, Ariza L, Bickel C, Lauterbach M, Konstantinides S, Rostock T, Munzel T, Wild PS. History of deep vein thrombosis is a discriminator for concomitant atrial fibrillation in pulmonary embolism. Thromb Res. 2015 Nov;136(5):899-906. doi: 10.1016/j.thromres.2015.08.024. Epub 2015 Sep 3.
- Derived from this study: PubMed 25616558Prochaska JH, Gobel S, Keller K, Coldewey M, Ullmann A, Lamparter H, Junger C, Al-Bayati Z, Baer C, Walter U, Bickel C, ten Cate H, Munzel T, Wild PS. Quality of oral anticoagulation with phenprocoumon in regular medical care and its potential for improvement in a telemedicine-based coagulation service--results from the prospective, multi-center, observational cohort study thrombEVAL. BMC Med. 2015 Jan 23;13:14. doi: 10.1186/s12916-015-0268-9.
- Derived from this study: PubMed 24685605Prochaska JH, Coldewey M, Gobel S, Keller K, Hendelmeier M, Konstantinides S, Munzel T, Wild PS; thrombEVAL Study Group. Evaluation of oral anticoagulation therapy: rationale and design of the thrombEVAL study programme. Eur J Prev Cardiol. 2015 May;22(5):622-8. doi: 10.1177/2047487314527852. Epub 2014 Mar 31.
- Study information homepageLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp S Wild, MD, MSc principal investigator
University Medical Center of Johannes Gutenberg-University Mainz, Germany
Thomas F Munzel, MD principal investigator
University Medical Center of Johannes Gutenberg-University Mainz, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulant Antagonists, Vitamin K and Other Coagulants Causing Adverse Effects in Therapeutic Use and Atrial Fibrillation, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in therapeutic range (time frame: Assessment during Year 1 after study enrolment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01809015, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018; AzTrials last refreshed its copy on 8 Nov 2026.