Register for New Oral Anticoagulants (NOAC)

This study is currently recruiting participants. (see Contacts and Locations)

Verified May 2012 by GWT-TUD GmbH

Sponsor:

Information provided by (Responsible Party):

GWT-TUD GmbH

ClinicalTrials.gov Identifier:

NCT01588119

First received: April 26, 2012

Last updated: May 3, 2012

Last verified: May 2012

History of Changes

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:

MedlinePlus related topics: Blood Thinners

U.S. FDA Resources

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)

Eligibility


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

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

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

No publications provided by GWT-TUD GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Beyer-Westendorf J, Förster K, Pannach S, Ebertz F, Gelbricht V, Thieme C, Michalski F, Köhler C, Werth S, Sahin K, Tittl L, Hänsel 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.


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:	May 3, 2012
Health Authority:	Germany: Ethics Commission

ClinicalTrials.gov processed this record on March 01, 2015

To Top