Anticoagulation TreatmentNOACNCT01588119
Register for New Oral Anticoagulants
An observational study of Anticoagulation Treatment, run by GWT-TUD GmbH at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulation Treatment
- How many people
- 5,000 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients in clinical routine
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Dresden on behalf of GWT-TUD GmbH
Dresden, 01307
Jan Beyer-Westendorf, MD, 0049 0351 458 ext. 2899, jan.beyer@uniklinikum-dresden.de
Jan Beyer-Westendorf, MD
About this study
Official title: Prospective Register Study to Record Safety and Efficacy of New Oral Anticoagulants
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran | in atrial fibrillation | |
| Rivaroxaban | in atrial fibrillation and VTE | |
| Apixaban | in atrial fibrillation and VTE | |
| Edoxaban | in atrial fibrillation and VTE |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anticoagulation TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GWT-TUD GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Beyer-Westendorf, MD, Principal investigator, study site at Universitätsklinikum Dresden on behalf of GWT-TUD GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588119
- Sponsor's protocol ID
- NOAC
- Acronym
- NOAC
- Status last verified
- Jan 2023
- First submitted
- 26 Apr 2012
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32335423Beyer-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.
PubMed 25739533Beyer-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.
PubMed 24859362
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Register Study to Record Safety and Efficacy of New Oral Anticoagulants
- ClinicalTrials.gov ID
- NCT01588119
- Acronym / sponsor ID
- NOAC / NOAC
- Conditions
- Anticoagulation Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- GWT-TUD GmbHUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 30 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dabigatran | – | –in atrial fibrillation |
| Rivaroxaban | – | –in atrial fibrillation and VTE |
| Apixaban | – | –in atrial fibrillation and VTE |
| Edoxaban | – | –in atrial fibrillation and VTE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients in clinical routine
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Derived from this study: PubMed 32335423Beyer-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.
- Derived from this study: PubMed 25739533Beyer-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.
- Derived from this study: PubMed 24859362Beyer-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.
Related trials for Anticoagulation Treatment
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
Active, not recruiting
Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation
Ischemic Stroke, Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Beyer-Westendorf, MD principal investigator
study site at Universitätsklinikum Dresden on behalf of GWT-TUD GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulation Treatment, run by GWT-TUD GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Beyer-Westendorf, MD (+49 351 458 ext. 2899, jan.beyer@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01588119, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.