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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01809015
Recruitment Status : Completed
First Posted : March 12, 2013
Last Update Posted : August 24, 2018
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, a Daiichi Sankyo Company
Sanofi
IMO Institut GmbH
PortaVita BV
The German Heart Foundation
Bayer
Information provided by (Responsible Party):
Philipp Wild, MD, MSc, Johannes Gutenberg University Mainz

Tracking Information
First Submitted Date March 8, 2013
First Posted Date March 12, 2013
Last Update Posted Date August 24, 2018
Actual Study Start Date January 2011
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 8, 2013)
  • 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01809015 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Oral Anticoagulation With Vitamin K Antagonists - The thrombEVAL Study Programme
Official Title A Study Programme for the Evaluation of Oral Anticoagulation Therapy With Vitamin K Antagonists
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition
  • Anticoagulant Antagonists, Vitamin K and Other Coagulants Causing Adverse Effects in Therapeutic Use
  • Atrial Fibrillation
  • Venous Thromboembolism
Intervention Not Provided
Study 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 22, 2018)
2318
Original Estimated Enrollment
 (submitted: March 8, 2013)
2500
Actual Study Completion Date March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01809015
Other Study ID Numbers UMCM-2010EPI01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Philipp Wild, MD, MSc, Johannes Gutenberg University Mainz
Study Sponsor Johannes Gutenberg University Mainz
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
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
PRS Account Johannes Gutenberg University Mainz
Verification Date August 2018