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Register for New Oral Anticoagulants (NOAC)

This study is currently recruiting participants.
Verified May 2012 by GWT-TUD GmbH
Sponsor:
Information provided by (Responsible Party):
GWT-TUD GmbH
ClinicalTrials.gov Identifier:
NCT01588119
First received: April 26, 2012
Last updated: May 3, 2012
Last verified: May 2012
History of Changes
  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:

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

Further study details as provided by GWT-TUD GmbH:

Estimated Enrollment: 2000
Study Start Date: November 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT01588119     History of Changes
Other Study ID Numbers: NOAC
Study First Received: April 26, 2012
Last Updated: May 3, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013