VerifyNow to Optimise Platelet Inhibition in Coronary Acute Syndrome (VERONICA)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 634
- 试验地点
- 21
- 主要终点
- Incidence of Net Adverse Cardiac Events (NACE). Net Adverse Cardiac Events, defined as a composite of: death from vascular causes (death from cardiovascular causes or cerebrovascular causes and any death without another known cause), non fatal MI, or non fatal stroke, Bleeding BARC type ≥ 2. At 12 months
研究概览
简要总结
To find out if the de-escalation from the more powerful antiplatelet agents prasugrel and ticagrelor to clopidogrel, guided by the VerifyNow® platelet aggregation measurement device, has a beneficial effect in the treatment of ACS.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with age 18 years or above; Patient is able to understand the nature of study and has provided written informed consent; Patients with Acute Coronary Syndrome and who underwent PCI during the admission with absorbable polymer stent who have been discharged on double antiplatelet therapy with Acetylsalicylic Acid and Ticagrelor or Prasugrel
排除标准
- •Patients with history of intracranial bleeding; Patients with contraindication for the use of Acetylsalicylic Acid or Clopidogrel or Ticagrelor or Prasugrel; Patients with major ischemic or hemorrhagic events during the first month; Patients with Thrombocytopenia <50,000 /μL; Patients with permanent oral anticoagulation; Patient is pregnant or breast feeding;Patients with impossibility to complete 1 year of follow-up; Patient´s life-expectancy is less than 24 months
结局指标
主要结局
Incidence of Net Adverse Cardiac Events (NACE). Net Adverse Cardiac Events, defined as a composite of: death from vascular causes (death from cardiovascular causes or cerebrovascular causes and any death without another known cause), non fatal MI, or non fatal stroke, Bleeding BARC type ≥ 2. At 12 months
Incidence of Net Adverse Cardiac Events (NACE). Net Adverse Cardiac Events, defined as a composite of: death from vascular causes (death from cardiovascular causes or cerebrovascular causes and any death without another known cause), non fatal MI, or non fatal stroke, Bleeding BARC type ≥ 2. At 12 months
次要结局
- Incidence of Death (Cardiovascular) at 12 months; Incidence of Death at 12 months; Incidence of Non fatal Myocardial Infarction (MI) at 12 months; Incidence of Stroke at 12 months; Incidence of Thrombosis in target lesion, at 12 months; Incidence of revascularization on target lesion at 12 months; Incidence of (BARC criteria ≥ 2) at 12 months
研究者
ARMANDO PEREZ DE PRADO
Scientific
Fundacion Epic