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: March 10, 2014
Last verified: March 2014

March 8, 2013
March 10, 2014
January 2011
March 2018   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01809015 on ClinicalTrials.gov Archive Site
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Evaluation of Oral Anticoagulation With Vitamin K Antagonists - The thrombEVAL Study Programme
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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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.

  • PHENPROCOUMON/VITAMIN K [VA Drug Interaction]
  • Atrial Fibrillation
  • Venous Thromboembolism
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2500
March 2018
March 2018   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01809015
UMCM-2010EPI01
Yes
Philipp Wild, MD, MSc, Johannes Gutenberg University Mainz
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
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
Johannes Gutenberg University Mainz
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP