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Quality management of NOACs in clinical practice

Quality management of NOACs in clinical practice

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00006002
Enrollment
200
Registered
2014-04-07
Start date
2014-09-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High risk patients with indication for anticoagulation with NOACs like atrial fibrillation, deep vein thrombosis and/or lung embolism.

Interventions

Group 1: Non-interventional prospective study: observation of high risk patient with indication for anticoagulation with NOACs like atrial fibrillation, deep vein thrombosis and/or lung embolism. No a

Sponsors

Universitätsklinikums Köln
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: High risk patients with indication for anticoagulation with NOACs like atrial fibrillation, deep vein thrombosis and/or lung embolism. a) Patients with suspected under-/overdose like renal/liver failure and/or non-compliance and/or intoxication; b) Patients with high risk of bleeding, especially patients who will get a cardiac catheterization with the necessary of antiplatelet drugs.

Exclusion criteria

Exclusion criteria: < 18 years; no high risk patients with treatment with NOACs

Design outcomes

Primary

MeasureTime frame
During the treatment with NOACs of high risk patients we want to proof (endpoints): clinical parameters (compliance [MARS-D], drug-interactions [AiD-Klinik], polypharmacy [MAI-Index], bleeding risk [HASBLED-Score]), TDM and activity of clotting.

Secondary

MeasureTime frame
No secondary endpoints

Countries

Germany

Contacts

Public ContactGuido Michels

Klinik III für Innere Medizin Herzzentrum des Universitätsklinikums Köln

guido.michels@uk-koeln.de0221-478-32401

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026