Chronic Coronary Syndrome Coronary Artery Disease Clogged coronary arteries
Conditions
Interventions
Group 2 (intervention): DOAC continuation
In group 2, all patients will continue to use their specific DOAC as usual.
This means that no adjustments of DOAC use will be made before and after ICA or
Sponsors
Zuyderland
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: o Patients aged between 18-85 years using DOAC and undergoing elective ICA or PCI. o Written informed consent
Exclusion criteria
Exclusion criteria: - Patients initially presenting with Acute Coronary Syndrome (STEMI, NSTEMI, UA) - Patients <18 or >85 years old - Calculated CLCR <30 mL/min - Patients simultaneously participating in another clinical trial - History or condition associated with increased bleeding risk, as listed below: o Major surgical procedure within 30 days before the procedure o Pre-procedural expectation that exclusive radial access is infeasible, including cases with a previously documented inaccessible radial artery. o History of GI bleeding in the previous 6 months o History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding o Chronic bleeding disorder o Known intracranial neoplasm, arteriovenous malformation, or aneurysm o Known anemia with last measured haemoglobin value <6 mmol/L [9.67 g/dL] o Current pregnancy or breast-feeding o Known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis), or ALT >3 x the ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint In hospital major bleeding, BARC bleeding definition 3 or 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints • 30 days follow-up - Major bleeding, BARC bleeding definition 3 or 5. - Major adverse cardiac and cerebrovascular events (MACCE): composite of death, myocardial infarction, revascularisation and stroke (haemorrhagic or ischemic) - NACE: the composite of MACE and major or minor bleeding. - Myocardial infarction - Stroke - Minor bleeding, BARC bleeding definition 1-2. | — |
Countries
Czech Republic, Hungary, Netherlands
Contacts
Public ContactS Janssen
Zuyderland
Outcome results
None listed