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Clinical Trials/NCT01588119
NCT01588119
Recruiting
Not Applicable

Prospective Register Study to Record Safety and Efficacy of New Oral Anticoagulants

GWT-TUD GmbH1 site in 1 country5,000 target enrollmentNovember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anticoagulation Treatment
Sponsor
GWT-TUD GmbH
Enrollment
5000
Locations
1
Status
Recruiting
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
December 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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