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

This study is ongoing, but not recruiting participants.
Sponsor:
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
Sanofi
IMO Institut GmbH
PortaVita BV
The German Heart Foundation
Bayer
Information provided by (Responsible Party):
Philipp Wild, MD, MSc, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01809015
First received: March 8, 2013
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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
PHENPROCOUMON/VITAMIN K [VA Drug Interaction]
Atrial Fibrillation
Venous Thromboembolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study Programme for the Evaluation of Oral Anticoagulation Therapy With Vitamin K Antagonists

Resource links provided by NLM:


Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Time in therapeutic range [ Time Frame: Assessment during Year 1 after study enrolment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Any Hospitalisation

  • Net clinical benefit [ Time Frame: Assessment at year 1 and 2 ] [ Designated as safety issue: No ]
    Composite of stroke, systemic embolism, pulmonary embolism, myocardial infarction, major and clinically relevant, non-major bleeding and death


Estimated Enrollment: 2500
Study Start Date: January 2011
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01809015

Locations
Germany
University Medical Center of the Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
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
Sanofi
IMO Institut GmbH
PortaVita BV
The German Heart Foundation
Bayer
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Philipp Wild, MD, MSc, Univ.-Prof. Dr. med. Philipp Wild, MSc, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01809015     History of Changes
Other Study ID Numbers: UMCM-2010EPI01
Study First Received: March 8, 2013
Last Updated: May 14, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Johannes Gutenberg University Mainz:
Oral Anticoagulation
Regular Medical Care
Coagulation Service
Vitamin-K Antagonists
Quality of therapy
Atrial fibrillation
Venous thromboembolism
Bypass surgery
Prosthetic heart valve

Additional relevant MeSH terms:
Atrial Fibrillation
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Thrombosis
Vitamins
Vitamin K
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014