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Register for New Oral Anticoagulants (NOAC)

This study is currently recruiting participants.
Verified August 2016 by GWT-TUD GmbH
Sponsor:
ClinicalTrials.gov Identifier:
NCT01588119
First Posted: April 30, 2012
Last Update Posted: January 20, 2017
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.
Information provided by (Responsible Party):
GWT-TUD GmbH
  Purpose
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
Anticoagulation Treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Register Study to Record Safety and Efficacy of New Oral Anticoagulants

Resource links provided by NLM:


Further study details as provided by GWT-TUD GmbH:

Estimated Enrollment: 3500
Study Start Date: November 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Dabigatran
in atrial fibrillation
Rivaroxaban
in atrial fibrillation and VTE
Apixaban
in atrial fibrillation and VTE
Edoxaban
in atrial fibrillation

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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