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Register for New Oral Anticoagulants (NOAC)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01588119
Recruitment Status : Recruiting
First Posted : April 30, 2012
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Patients, who are adjusted to a new oral anticoagulant (Dabigatran, Rivaroxaban, Apixaban, Edoxaban) in routine treatment will recorded in this register. Within this register a characterization of patients (with regard to demography and indication) and therapy (with regard to medication, dose and duration) will be done. On basis of defined clinical relevant end points the long-term efficacy and safety will be evaluated.

Condition or disease
Anticoagulation Treatment

Study Design

Study Type : Observational
Estimated Enrollment : 3500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Register Study to Record Safety and Efficacy of New Oral Anticoagulants
Study Start Date : November 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Dabigatran
in atrial fibrillation
Rivaroxaban
in atrial fibrillation and VTE
Apixaban
in atrial fibrillation and VTE
Edoxaban
in atrial fibrillation


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients in clinical routine
Criteria

Inclusion Criteria:

  • indication for treatment with long term anticoagulation
  • initial adjustment or change to nex oral anticoagulant within routine treatment
  • indication for treatment with long term anticoagulation within the register:
  • permanent anticoagulation in arterial fibrillation
  • intended anticoagulation in acute venous thromboembolism for min. 3 months
  • other anticoagulation for min. 3 months within the approved indication

Exclusion Criteria:

  • missing Informed Consent Form
  • missing phone number for telephone follow up
  • contraindication for therapy with new oral anticoagulant (Dabigatran, Rivaroxaban, Apixaban, Edoxaban) according to Summary of Product Characteristics
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588119


Contacts
Contact: Jan Beyer-Westendorf, MD +49 351 458 ext 3659 jan.beyer@uniklinikum-dresden.de

Locations
Germany
Universitätsklinikum Dresden on behalf of GWT-TUD GmbH Recruiting
Dresden, Germany, 01307
Contact: Jan Beyer-Westendorf, MD    0049 0351 458 ext 3659    jan.beyer@uniklinikum-dresden.de   
Principal Investigator: Jan Beyer-Westendorf, MD         
Sponsors and Collaborators
GWT-TUD GmbH
Investigators
Principal Investigator: Jan Beyer-Westendorf, MD study site at Universitätsklinikum Dresden on behalf of GWT-TUD GmbH