E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Anticoagulation during percutaneous coronary intervention |
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E.1.1.1 | Medical condition in easily understood language |
Blood thinners during percutaneous coronary intervention |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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 <45 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
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E.5 End points |
E.5.1 | Primary end point(s) |
6.1.1 Laboratory measurements
- Basic tests of haemostasis: APTT, PT o To evaluate global functioning of intrinsic and extrinsic pathway - Fibrinogen, D-dimer, fibrinopeptide A and B, trombin generation test, soluble fibrin o To evaluate the presence, formation, and degradation of fibrin - Panel of activated coagulation factors in complex with inhibitors, or marker of activation (F1+2) o Factor 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. o To evaluate the extent of platelet activation; - T-TAS o To 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 o To assess intrinsic pathway (with or without heparinase), anti-Xa, anti-IIa, and non-activated coagulation - TEG: global haemostasis assay o This 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 fibrinolysis with and without platelet involvement will be measured. - ACT (hemochron) o POC APTT - Global thrombosis test (Thromboquest) o This POC test is usefull to measure clotting and lysis time, and thrombus stability in whole blood under high sheer stress circumstances as is seen in the arterial bed of arterial diseased patients.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the start of the procedure (before UFH/NaCl administration, T=0), after 30 minutes (T=30), after 1 hour (T=60), after 2 hours (T=120), and after 4 hours (T=240). |
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E.5.2 | Secondary end point(s) |
Clinical events related to bleeding or thrombosis |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At discharge and after 30 days |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Blinded to the treating interventional cardiologist |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |