coronary artery disease percutaneous coronary intervention
Conditions
Interventions
Group 1 (reference cohort)
40 patients without chronic NOAC treatment undergoing elective CAG or PCI with
peri-procedural UFH
Group 2 (NOAC cohort)
80 patients with chronic NOAC treatment undergoing
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient must meet all of the following criteria: - Male or female >= 18 years - Undergoing non-emergent CAG or PCI - Loaded with P2Y12 inhibitors before PCI - Patients with signed informed consent
Exclusion criteria
Exclusion criteria: Patients who fulfill the above mentioned inclusion criteria but who manifest any of the following exclusion criteria will not be eligible for the study: - Patients with hematologic, renal (estimated glomerular filtration 2 times the upper limit of normal), inflammatory (CRP >2 times the upper limit of normal) or neoplastic disorders - Patients using nonsteroidal anti-inflammatory drugs, corticosteroids, or hormone replacement therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Laboratory measurements 1) APTT, PT 2) Fibrinogen, D-dimer, fibrinopeptide A and B, trombin generation test, soluble fibrin 3) factor XIIa and kallikrein; XIa, IXa, Xa- in complex with inhibitors and prothrombin fragment 1+2 4) Anti-Xa 5) Soluble platelet release markers including P-selectin, GpVI, CD40L etc. 6) T-TAS Point-of-care tests 1) ClotPro IN, HI, RVV, ECA, and NA-tests 2) TEG: global haemostasis assay 3) Activated Clotting Time (ACT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical events related to bleeding or thrombosis at discharge, and after 30 days | — |
Countries
Netherlands
Outcome results
None listed