Register for New Oral Anticoagulants

NCT01588119 | Unknown

• 1 other identifier: NOAC
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Anticoagulation Treatment

Study Arms (4)

Dabigatran

in atrial fibrillation

Rivaroxaban

in atrial fibrillation and VTE

Apixaban

in atrial fibrillation and VTE

Edoxaban

in atrial fibrillation and VTE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients in clinical routine

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GWT-TUD GmbH: lead

Study Sites (1)

Universitätsklinikum Dresden on behalf of GWT-TUD GmbH

Dresden, 01307, Germany

RECRUITING

Related Publications (3)

• Beyer-Westendorf J, Marten S, Naue C, Tittl L, Hansel U, Beyer-Westendorf I, Mizera H, Schreier T, Festerling E, Reitter A, Spindler M, Bornhauser M. Rates, management and outcome of bleeding complications during edoxaban therapy in daily care - results from the DRESDEN NOAC REGISTRY. Thromb Res. 2020 Jun;190:91-98. doi: 10.1016/j.thromres.2020.03.021. Epub 2020 Apr 19.

  PMID: 32335423 DERIVED

• Beyer-Westendorf J, Ebertz F, Forster K, Gelbricht V, Michalski F, Kohler C, Werth S, Endig H, Pannach S, Tittl L, Sahin K, Daschkow K, Weiss N. Effectiveness and safety of dabigatran therapy in daily-care patients with atrial fibrillation. Results from the Dresden NOAC Registry. Thromb Haemost. 2015 Jun;113(6):1247-57. doi: 10.1160/TH14-11-0954. Epub 2015 Mar 5.

  PMID: 25739533 DERIVED

• Beyer-Westendorf J, Forster K, Pannach S, Ebertz F, Gelbricht V, Thieme C, Michalski F, Kohler C, Werth S, Sahin K, Tittl L, Hansel U, Weiss N. Rates, management, and outcome of rivaroxaban bleeding in daily care: results from the Dresden NOAC registry. Blood. 2014 Aug 7;124(6):955-62. doi: 10.1182/blood-2014-03-563577. Epub 2014 May 23.

  PMID: 24859362 DERIVED

Study Officials

• Jan Beyer-Westendorf, MD

  study site at Universitätsklinikum Dresden on behalf of GWT-TUD GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Beyer-Westendorf, MD

CONTACT

+49 351 458; jan.beyer@uniklinikum-dresden.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: April 30, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

DE (1)