Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01588119
Other study ID # NOAC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2011
Est. completion date December 2024

Study information

Verified date January 2023
Source GWT-TUD GmbH
Contact Jan Beyer-Westendorf, MD
Phone +49 351 458
Email jan.beyer@uniklinikum-dresden.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Universitätsklinikum Dresden on behalf of GWT-TUD GmbH Dresden

Sponsors (1)

Lead Sponsor Collaborator
GWT-TUD GmbH

Country where clinical trial is conducted

Germany,