Register for New Oral Anticoagulants | NCT01588119

Studies
Register for New Oral Anticoagulants

NCT01588119

Sponsor

GWT-TUD GmbH

Status

Unknown status

Last Update Posted

Jan 18, 2023Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Anticoagulation Treatment

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Apr 26, 2012

First Submission Date that Met QC Criteria

Apr 26, 2012

First Posted Date

Apr 30, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2023

Last Update Posted Date

Jan 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dabigatran		in atrial fibrillation
Rivaroxaban		in atrial fibrillation and VTE
Apixaban		in atrial fibrillation and VTE
Edoxaban		in atrial fibrillation and VTE

Interventions

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients in clinical routine

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jan Beyer-Westendorf, MD	Contact	+49 351 458	2899	jan.beyer@uniklinikum-dresden.de

Overall Officials

Name	Affiliation	Role
Jan Beyer-Westendorf, MD	study site at Universitätsklinikum Dresden on behalf of GWT-TUD GmbH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum Dresden on behalf of GWT-TUD GmbH	Recruiting	Dresden		01307	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32335423	Derived	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.
25739533