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

NCT01809015 | Completed DMC

• 1 other identifier: UMCM-2010EPI01
• Study Type: observational
• Target: 2,318
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Contraindication to VKA treatment, e.g. pregnancy or known hypersensitivity
• Participation in other clinical trial

Sponsors & Collaborators

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

Study Sites (1)

University Medical Center of the Johannes Gutenberg University Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Related Publications (8)

• 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.

  PMID: 35629401 DERIVED

• Eggebrecht 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.

  PMID: 33510343 DERIVED

• Michal 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.

  PMID: 31922545 DERIVED

• Prochaska 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.

  PMID: 29948286 DERIVED

• Prochaska 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.

  PMID: 28457013 DERIVED

• Keller 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.

  PMID: 26376038 DERIVED

• Prochaska 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.

  PMID: 25616558 DERIVED

• Prochaska 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.

  PMID: 24685605 DERIVED

Related Links

• Study information homepage

MeSH Terms

Conditions

Atrial Fibrillation; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thromboembolism; Embolism and Thrombosis; Vascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. med. Philipp Wild, MSc

Study Record Dates

• First Submitted: March 8, 2013
• First Posted: March 12, 2013
• Study Start: January 1, 2011
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: August 24, 2018

Record last verified: 2018-08

Locations

DE (1)