Assessment of Platelet REACtivity After Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 7
- 主要终点
- Evaluate the effectiveness of ticagrelor compared to clopidogrel and aspirin for the suppression of residual platelet reactivity by a system to verify the patient's platelet reactivity (VerifyNow P2Y12 assay).
研究概览
简要总结
A high platelet reactivity in patients with severe symptomatic Aortic Stenosis (AS) selected for TAVI (Transcatheter aortic valve implantation) procedure has been demonstrated previously, and the use of double antiaggregation therapy (DAPT) with Clopidogrel and Acetylsalicylic acid (ASA) do not achieve consistent and adequate suppression of platelet reactivity. The purpose of this study is evaluate the efficacy of ticagrelor alone versus DAPT with clopidogrel and aspirin for the suppression of high platelet reactivity following TAVI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For inclusion in the study subjects should fulfill the following criteria:
- •Provision of informed consent prior to any study specific procedures.
- •Adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial.
- •Patients with degenerative symptomatic severe AS accepted for TAVI after evaluation of the Heart Team of each center.
- •Patients who are not participating in any other clinical trial or research study (registries allowed).
排除标准
- •Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- •Recent stroke <14 days prior to TAVI, non-revascularized severe coronary or carotid artery disease (>70% stenosis) or life expectancy < 12 months
- •Patients under chronic oral anticoagulation
- •Patients with proven allergy to aspirin, clopidogrel or ticagrelor
- •Patients that after TAVI cannot undergo a regimen of single or dual antiplatelet therapy for 3 months due to a new post-TAVI medical indication
- •Known pregnancy or breast-feeding
- •Concomitant oral or intravenous therapy with potent inhibitors of cytochrome P450 3A (CYP3A) that cannot be suspended during the course of the study. Medications considered as potent inhibitors are: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (or erythromycin but not astromicin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and more than a daily liter of grapefruit juice.
- •Thrombocytopenia (<50,000 platelets U/L) well documented and clinically relevant.
- •Patients with documented moderate or severe hepatic insufficiency
- •Any condition that may put the patient at risk or influence the outcome of the trial
- •Patients previously randomized in this trial or in another clinical trial with an investigational product or device over the past 30 days.
- •Patients who cannot attend follow up visits scheduled in the study
研究组 & 干预措施
Ticagrelor
Patients with high-on-treatment platelet reactivity (PRU ≥ 208)
干预措施: Ticagrelor 90 mg twice per day during three months following TAVI (Drug)
Aspirin/Clopidogrel
Patients with high-on-treatment platelet reactivity (PRU ≥ 208)
干预措施: Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVI (Drug)
结局指标
主要结局
Evaluate the effectiveness of ticagrelor compared to clopidogrel and aspirin for the suppression of residual platelet reactivity by a system to verify the patient's platelet reactivity (VerifyNow P2Y12 assay).
时间窗: Three months after antiplatelet treatment initiation following procedure.
次要结局
- Evaluate the effectiveness of ticagrelor compared to clopidogrel and aspirin for the suppression of residual platelet reactivity by VerifyNow P2Y12 assay.(Six hours after antiplatelet treatment initiation following procedure.)
研究者
Andres Iñiguez Romo, MD, PhD
Chief, Cardiology Department, Hospital Alvaro Cunqueiro
Hospital de Meixoeiro