EUCTR2021-003927-13-ES进行中（未招募）1 期
Single antiplatelet therapy with Ticagrelor vs Aspirin after Transcatheter Aortic Valve Implantation: multicenter randomized clinical trial. REAC TAVI 2 - REAC-TAVI 2
Fundación Biomédica Galicia Sur0 个研究点目标入组 1,206 人开始时间: 2021年10月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,206
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Provisión de consentimiento informado antes de cualquier procedimiento específico del estudio.
- •2) Pacientes adultos (mayores de 18 años) con capacidad para comprender y aceptar la participación en el ensayo clínico.
- •3) Pacientes con EA degenerativa sintomática grave aceptados para TAVI con cualquiera de los dispositivos TAVI comercialmente aprobados después de la evaluación del Heart Team de cada centro, y con al menos una de las siguientes comorbilidades:
- •Diabetes Mellitus, deben mantenerse los criterios diagnósticos actuales de la OMS para la diabetes: glucosa plasmática en ayunas = 7,0 mmol / l (126 mg / dl) o glucosa plasmática a las 2 h = 11,1 mmol / l (200 mg / dl), o en tratamiento con un hipoglucemiante oral o insulina
- •Enfermedad arterial coronaria previa (STEMI, NSTEMI, angina estable u otras) documentada mediante pruebas de detección de isquemia invasivas o no invasivas o estudios de imágenes
- •Enfermedad arterial periférica previa documentada mediante pruebas de detección de isquemia invasivas o no invasivas o estudios de imágenes.
- •4) TAVI exitoso realizado por cualquier acceso vascular.
- •5) Pacientes que no están participando en ningún otro ensayo clínico o estudio de investigación (registros permitidos).
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1196
排除标准
- •1) Patients under chronic oral anticoagulation for any specific pathology
- •2)Patients that cannot undergo a regimen of single antiplatelet therapy after TAVI
- •3) History of overt major bleeding or intracranial hemorrhage
- •4) Active pathological bleeding
- •5) History of ischemic stroke within the last 30 days prior TAVI
- •6) Patients with documented severe hepatic insufficiency
- •7) Known pregnancy, breast-feeding, or intend to become pregnant during the study period
- •8) Concomitant oral or intravenous therapy with potent inhibitors of cytochrome P450 3A (CYP3A) that cannot be suspended during the study. Section 13.1 Ticagrelor Overdose: any dose over the clinically intended dose.
- •9) Patients randomized in another clinical trial with an investigational product or device over the past 30 days
- •10) Patients who cannot attend follow-up visits scheduled in the study.
- •11) History of allergic reactions or intolerance to Ticagrelor orAspirin or any of the excipients
研究者
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