Register for New Oral Anticoagulants (NOAC)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
GWT-TUD GmbH Identifier:
First received: April 26, 2012
Last updated: August 18, 2015
Last verified: August 2015
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.

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: 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)

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01588119

Universitätsklinikum Dresden on behalf of GWT-TUD GmbH
Dresden, Germany, 01307
Sponsors and Collaborators
Principal Investigator: Jan Beyer-Westendorf, MD study site at Universitätsklinikum Dresden on behalf of GWT-TUD GmbH
  More Information

No publications provided by GWT-TUD GmbH

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: GWT-TUD GmbH Identifier: NCT01588119     History of Changes
Other Study ID Numbers: NOAC
Study First Received: April 26, 2012
Last Updated: August 18, 2015
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 24, 2015