Mechanisms Involved in the Bleeding Risk of Patients With Coronary Artery Diseased Previous Stroke or Transient Ischemic Attack in Use of Antiplatelet Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Residual platelet activity by VerifyNow Aspirin (Aspirin reactivity units)
研究概览
简要总结
Background: About 5% of patients with acute coronary syndrome (ACS) have had previously ischemic stroke (IS) or transitory ischemic attack (TIA). This is a high-risk population, with a high incidence of ischemic events, and also of bleeding events. While the high ischemic risk in this population is attributed to a higher prevalence of cardiovascular risk factors, their predisposition to bleeding events is not well understood. Hypothesis: The increased bleeding risk in ACS patients with history of cerebrovascular event may be justified by a low platelet activity. Methods: Unicentric, prospective, case-control study, which included approximately 100 post-ACS patients with history of IS/TIA previously to the acute coronary event (Case Group) and 100 patients without IS/TIA (Control group). The groups were matched for gender, age, and ACS type and year of occurrence. All patients were taking aspirin, and the main exclusion criteria were use of dual antiplatelet therapy, previous hemorrhagic stroke, severe renal dysfunction, thrombocytopenia or coagulopathy. Main analysis: Platelet aggregation was evaluated by 6 methods: VerifyNow Aspirin®, VerifyNow P2Y12®, PFA 100®, thrombelastography (ReoRox®), light transmission aggregometry with ADP (LTA ADP) and epinephrine (LTA EPI) as agonists. Additional analysis: genetic, HDL transport and inflammatory evaliation
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Post-ACS patients with history of IS/TIA previously to the acute coronary event and taking aspirin
- •Sign the consent form
排除标准
- •Hemorrhagic stroke
- •Another antiplatelet drug than aspirin
- •Use of Anti inflammatory drug
- •Severe chronic kidney dysfunction
- •Liver disease
- •Coagulopathy
- •Platelet disfunction
- •Thrombocytopenia or thrombocytosis
- •Refuse to sign the consent form
结局指标
主要结局
Residual platelet activity by VerifyNow Aspirin (Aspirin reactivity units)
时间窗: in the selection visit
次要结局
- Baseline platelet activity by VerifyNow P2Y12 (P2Y12 reactivity units)(in the selection visit)
