Thrombosis after a percutaneous coronary intervention with stent placement Thrombosis after angioplasty with stent placement
Conditions
Interventions
Edoxaban: 60, 30 and 15 mg provided as film coated tablets for oral use.
Subjects receive 60 mg edoxaban once-daily. A dose reduction (30 mg edoxaban
once-daily) is determined for subjects with one
o
In EU countries, according to SmPC concomitant use of edoxaban with
cyclosporine, dronedarone, erythromycin, or ketoconazole requires dose
reduction to 30 mg once-daily. Concomitant use of edoxaban
antithrombotic regimen
Edoxaban
Sponsors
Daiichi Pharmaceutical
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1.OAC indication for atrial fibrillation for a period of at least 12 months following successful PCI with stenting in adult male and female patients *18 years of age. Eligibility is assessed 4 hours after sheath removal and within 5 days after successful PCI with stent placement. If a staged PCI is planned, eligibility is assessed after completion of the last stage.;Successful PCI definition: The success of a PCI procedure is defined by 2 interrelated components: angiographic findings, procedural / clinical outcomes as detailed below: - Angiographic Success - A minimum stenosis diameter of
Exclusion criteria
Exclusion criteria: Bleeding risks or systemic conditions 1.Known bleeding diathesis, including but not limited to, a.Uncontrolled active bleeding, encompassing both ISTH major and clinically relevant non-major bleeding, preceding randomization. b.Lesion or condition, if considered to be a significant risk for major bleeding. This may include but is not limited to: unresolved gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding (e.g. malignancies with metastasis), recent unresolved brain or spinal injury, recent brain, spinal or ophthalmic surgery, any intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms (of more than 3.5 cm) or major intraspinal or intracerebral vascular abnormalities.;Medication-related 2.INR > 2.5 (the subject can be reconsidered at a later time, but within 5 days of sheath removal). 3.Contraindication to edoxaban, VKA, ASA and/or P2Y12 antagonists; 4.Concomitant treatment with other antithrombotic agents, fibrinolytic therapy and chronic nonsteroidal anti-inflammatory drugs (NSAIDs).;Concomitant conditions and therapies 5. Critically ill or hemodynamically unstable subjects (at the time of randomization) including: a.cardiogenic shock or acute decompensated heart failure, with the requirement for vasopressor agents or inotropic support or mechanical support to support circulation b.respiratory failure requiring endotracheal intubation and mechanical ventilation. 6.Any prior mechanical valvular prosthesis; 7.Planned coronary or vascular intervention or major surgery within 12 months; Randomization must be deferred to the last stage in a multistep, multivessel PCI procedure; 8.Moderate or severe mitral stenosis; 9.Ischemic stroke within 2 weeks prior to randomization; 10.Uncontrolled severe hypertension with a systolic blood pressure (BP) *180 mmHg and/or diastolic BP * 120 mmHg; 11.Severe renal impairment with estimated creatinine clearance (CrCL) < 15 mL/min or on dialysis; 12.Known abnormal liver function prior to randomization (incl. hepatic disease or biochemical evidence of significant liver derangement known prior to randomization;Other exclusion criteria 13.Any of the following abnormal local laboratory results prior to randomization: a.Platelet count < 50 x109/L b.Hemoglobin < 8 mg/dL 14.Unable to provide written IC; 15.Female subjects of childbearing potential without using highly effective contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilised, or has not had a hysterectomy at least three months prior to the start of this study). Females taking oral contraceptives should have been on therapy for at least three months. Adequate contraceptives include: Combined (estrogen and progestogen containing) oral, intravaginal, transdermal, hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence); 16.Pregnant or breast-feeding subjects; 17.Assessment that the subject is not likely to comply with the study procedures or have complete follow-up; 18.Participating in another clinical trial that potentially interfer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the composite of major or clinically relevant non-major bleeding (MCRB) defined according to the ISTH bleeding definitions, analyzed as time to first occurrence of any component. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Main efficacy endpoint (MEE), defined as the composite of cardiovascular (CV) death, stroke, systemic embolic events (SEE), spontaneous myocardial infarction (MI) and definite stent thrombosis (as per ARC consensus definitions). - Net clinical benefit (NCB), defined as the composite of CV death, stroke, SEE, spontaneous MI, definite stent thrombosis and ISTH-defined major bleeding. - Main thromboembolic event, defined as composite of cardiac or thromboembolic death (thromboembolic death considered to be thromboembolic in origin (including thromboembolic stroke, pulmonary embolism, any other systemic embolism), ischemic stroke, SEE, spontaneous MI and definite stent thrombosis. - ISTH-defined major bleeding - Any bleeding defined as the composite of major, clinically relevant non-major and minor bleeding (ISTH definition) - Symptomatic intracranial hemorrhage (ICH) - Composite of stroke and SEE - Composite of all-cause death, stroke, SEE, spontaneous MI and definite stent thrombosis - Composite of CV death, spontaneous MI and definite stent thrombosis - The single components of the composite primary and secondary endpoints mentioned above are explored, as well as specific subcategories (e.g., hemorrhagic, ischemic and undetermined stroke) | — |
Countries
The Netherlands
Outcome results
None listed