Anticoagulation during percutaneous coronary intervention
Conditions
Interventions
Trade Name: Heparin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: HEPARIN
CAS Number: 9005-49-6
Other descriptive name: HEPARIN
Concentration unit: IU/ml international unit(s)/milli
Sponsors
St. Antonius Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient must meet all of the following criteria: - Male or female = 18 years - Undergoing elective PCI - Loaded with P2Y12 inhibitors before PCI - Patients with signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
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 rate 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 |
|---|---|
| Main Objective: 1)To investigate if patients treated with chronic NOAC without additional periprocedural UFH during PCI are sufficiently anticoagulated without additional UFH as compared to patients without chronic OAC with periprocedural UFH 2)To investigate if patients that are sufficiently are anticoagulated by NOACs can be identified before the PCI procedure by a point-of-care test 3)To investigate if patients treated with chronic NOAC with additional periprocedural UFH during PCI are hypocoaguable as compared to patients without chronic OAC with periprocedural UFH ;Secondary Objective: Not applicable;Primary end point(s): 6.1.1Laboratory measurements -Basic tests of haemostasis: APTT, PT oTo evaluate global functioning of intrinsic and extrinsic pathway -Fibrinogen, D-dimer, fibrinopeptide A and B, trombin generation test, soluble fibrin oTo evaluate the presence, formation, and degradation of fibrin -Panel of activated coagulation factors in complex with inhibitors, or marker of activation (F1+2) oFactor XIIa and kallikrein; XIa, IXa, Xa, in complex with inhibitors and prothrombin fragment 1+2, to evaluate contact and intrinsic activated coagulation activation -Anti-Xa -Platelet-bound P-selectin expression; soluble platelet release markers including P-selectin, GpVI, CD40L etc. oTo evaluate the extent of platelet activation; -T-TAS oTo evaluate the primary hemostasis (vWF-mediated platelet adhesion to collagen, Platelet activation and aggregation) 2.Point-of-care tests -ClotPro IN, HI, RVV, ECA, and NA-tests oTo assess intrinsic pathway (with or without heparinase), anti-Xa, anti-IIa, and non-activated coagulation -TEG: global haemostasis assay oThis assay contains separate channels which activate the intrinsic and extrinsic coagulation pathway, and also one with both intrinsic and extrinsic activation but strong GP2b3a inhibition. This allows to discriminate clotting ability with and without platelet activation. Clotting time, strength, and fibrinolys | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical events related to bleeding or thrombosis ;Timepoint(s) of evaluation of this end point: At discharge and after 30 days | — |
Countries
Netherlands
Contacts
Public ContactResearch physician
St. Antonius Hospital
Outcome results
None listed