Monitoring the effect of oral anticoagulants during cardiac catheterisatio
Phase 4
Recruiting
- Conditions
- coronary artery diseasepercutaneous coronary intervention10011082
- Registration Number
- NL-OMON50931
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
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
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 <30
ml/min/1.73m2), hepatic (liver enzymes >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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Laboratory measurements<br /><br>1) APTT, PT<br /><br>2) Fibrinogen, D-dimer, fibrinopeptide A and B, trombin generation test,<br /><br>soluble fibrin<br /><br>3) factor XIIa and kallikrein; XIa, IXa, Xa- in complex with inhibitors and<br /><br>prothrombin fragment 1+2<br /><br>4) Anti-Xa<br /><br>5) Soluble platelet release markers including P-selectin, GpVI, CD40L etc.<br /><br>6) T-TAS<br /><br><br /><br>Point-of-care tests<br /><br>1) ClotPro IN, HI, RVV, ECA, and NA-tests<br /><br>2) TEG: global haemostasis assay<br /><br>3) Activated Clotting Time (ACT)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Clinical events related to bleeding or thrombosis at discharge, and after 30<br /><br>days</p><br>