Status:

COMPLETED

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

Lead Sponsor:

Johannes Gutenberg University Mainz

Collaborating Sponsors:

Ministry of Health, Rhineland-Palatinate, Germany

Ministry of Economics, Rhineland-Palatinate, Germany

Conditions:

Anticoagulant Antagonists, Vitamin K and Other Coagulants Causing Adverse Effects in Therapeutic Use

Atrial Fibrillation

Eligibility:

All Genders

18+ years

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-exp...

Eligibility Criteria

Inclusion

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

Exclusion

    Key Trial Info

    Start Date :

    January 1 2011

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2018

    Estimated Enrollment :

    2318 Patients enrolled

    Trial Details

    Trial ID

    NCT01809015

    Start Date

    January 1 2011

    End Date

    March 1 2018

    Last Update

    August 24 2018

    Active Locations (1)

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    University Medical Center of the Johannes Gutenberg University Mainz

    Mainz, Rhineland-Palatinate, Germany, 55131