Register for New Oral Anticoagulants (NOAC)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2016 by GWT-TUD GmbH
Sponsor:
GWT-TUD GmbH
Information provided by (Responsible Party):
GWT-TUD GmbH
ClinicalTrials.gov Identifier:
NCT01588119
First received: April 26, 2012
Last updated: January 21, 2016
Last verified: January 2016
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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:
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
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 ClinicalTrials.gov identifier: NCT01588119
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | January 21, 2016 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Anticoagulants |
ClinicalTrials.gov processed this record on September 29, 2016