NCT05122455Befejeződött2/3. fázis
Effects of Edoxaban on Platelet Aggregation
Effects of Edoxaban on Platelet Aggregation in Patients With Stable Coronary Artery Disease
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. ápr. 27.
Rövid összefoglaló (regiszter, angolul)
Rationale: The interaction between nonvitamin K oral anticoagulants (NOACs) and platelet aggregation is complex. The direct activated factor X inhibitors (factor Xa inhibitors) an NOAC antagonizes thrombin generation, one of most important platelet agonist, so that, factor Xa inhibitors has a potential effect in decreasing thrombin-mediated platelet aggregation. On the other hand, patients who experience ACS continue to have a hypercoagulable state for long periods after the index event. The COMPASS trial showed that, in patients with stable coronary artery disease (SCAD), Rivaroxaban (a direct anti-Xa inhibitor) in addition to antiplatelet agent, compared to antiplatelet therapy alone, reduced the composite endpoint of myocardial infarction, stroke and death. Objective: Analyze the role of edoxaban on platelet aggregation in SCAD patients. Methods and Results: This is a prospective, non-randomized, interventional study of SCAD patients taking low-dose acetylsalicylic acid (ASA). Subjects initially will receive in the following sequence: ASA 100 mg once daily (QD) plus edoxaban 60 mg QD, clopidogrel 75 mg QD alone, clopidogrel 75 mg QD plus edoxaban 60 mg QD, and edoxaban 60 mg QD alone. Platelet function will be assessed by standard of care technology, at baseline and after each intervention phase, by Multiplate-ADP® (primary endpoint), Multiplate-Aspi® and Multiplate-TRAP®. In addition to immature platelets fraction (% IPF) and count (IPC). Coagulability will be assessed, at baseline and after each intervention phase, by thromboelastogram (TEG) assessment. Specifically, after the phases in which edoxaban will be administered activated factor X (FXa) level and Plasminogen activator inhibitor-1 (PAI-1) will be evaluated in addition to previous. Finally, inflammatory markers will be, at same way, assessed at baseline and after intervention each phase: ultrasensitive C-reactive protein (us-PCR). Keywords: edoxaban, direct factor Xa inhibitor, stable coronary artery disease, aspirin, clopidogrel, platelet aggregation.
- Állapot (regiszter)
- Befejeződött
- Fázis (regiszter)
- 2/3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 61 (tényleges)
- Első benyújtás
- 2021. okt. 19.
- Kezdés
- 2021. szept. 14.
- Elsődleges befejezés
- 2024. jún. 24.
- Fő szponzor
- University of Sao Paulo
- Betegségek
- Koszorúér-betegség
- NCT-szám
- NCT05122455
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2/3. fázis
- Bevont résztvevők: 61
- 2021. szept. 14. és az elsődleges befejezés (2024. jún. 24.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Previous history of high gastrointestinal bleeding
- Percutaneous coronary intervention (PCI) in the last 3 months with conventional stent and in the last 6 months with drug-eluting stent.
- Previous hemorrhagic stroke;
- Current or last 30 days use of anticoagulant or antiplatelet therapy, except ASA;
- Concomitant use of P-glycoprotein inhibitors such as azithromycin, clarithromycin, erythromycin, itraconazole, ketoconazole, verapamil, quinidine, except amiodarone;
- Concomitant use of P-glycoprotein inducers, such as Rifampicin;
- Known abuse of alcohol, drugs, or medications in the 12 months prior to consent for this study;
- Cancer therapy 5 years prior to consent for this study;
Más betegség
- Clinically active bleeding or clinically significant bleeding in the last year.
- Peptic ulcer active in the last 60 days
- Surgical myocardial revascularization (CABG) in the last 90 days
- Percutaneous coronary intervention (PCI) or surgical myocardial revascularization (CABG) planned within the next 60 days;
- Moderate or severe liver failure associated with coagulation disorders (Child-Pugh B or C)
- Hypersensitivity to edoxaban or formula components;
- Chronic kidney disease: glomerular filtration rate estimated at <50 mL/min/1.73m², calculated using the Cockcroft-Gault equation;
- Medicines that will further increase the risk of bleeding (such as nonsteroidal anti-inflammatory drugs).
Laborértékek
- Hemoglobin <10 g / dl at randomization;
- Platelets <100,000 or >500,000 µ/L
Egyéb
- Need for lumbar puncture
- Atrial fibrillation
- Metal valve prosthesis
- Pregnant women or women of childbearing potential;
- Weight <60 kg;
- HAS-BLED score ≥ 3 points;
- Participation in another study within 30 days of signing the consent form.
Kiket keres a vizsgálat
- Patients aged between 18 and 75 years
- Confirmed diagnosis of CAD using ASA 100 mg once a day. The following will be considered for CAD diagnosis: previous history of type 1 AMI (at least one year ago), according to the fourth universal definition of myocardial infarction (Thygesen, Alpert et al. 2018) and/or coronary angioplasty and/or coronary artery bypass graft surgery myocardium and/or coronary angiography showing at least 50% obstruction in one of the main epicardial vessels.
- Agreement to sign the free and informed consent form.
Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Instituto do Coração InCor, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo | São Paulo | Brazília | Ismeretlen állapot |
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