Comparison of Antiplatelet Therapy With Clopidogrel and Ticagrelor in Patients After Cardiac Arrest Treated With Therapeutic Hypothermia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- VerifyNow P2Y12Test - Platelet Reactivity
研究概览
简要总结
There is growing evidence that standard dual antiplatelet therapy with acetylsalicylic acid (ASA) and clopidogrel is not as effective in the setting of therapeutic hypothermia after cardiac arrest as in normothermic patients. The reasons for this are probably slower gastrointestinal motility, absorption and liver metabolism required for clopidogrel to take action. Since ticagrelor has faster intestinal absorption and no need for liver metabolism we expect its effect to be good even in patients with therapeutic hypothermia after cardiac arrest. Patients treated with therapeutic hypothermia after cardiac arrest and percutaneous coronary intervention will be randomised into two groups. One will be treated with ASA and clopidogrel and the other with ASA and ticagrelor. Blood samples will be collected before and 2, 4, 12, 22 and 48 hours after P2Y12 inhibitor administration. Platelet function will be measured by VerifyNow P2Y12 assay and by Multiplate ADPTest. Differences between the groups will be analysed.
Hypothesis: Antiplatelet therapy with ticagrelor is more effective than therapy with clopidogrel in the comatose survivors of cardiac arrest treated with therapeutic hypothermia and percutaneous coronary intervention (PCI).
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
- •Female and male over 18 years old
- •Unconscious survivors of cardiac arrest treated with therapeutic hypothermia
- •Acute coronary syndrome (NSTEMI or STEMI) as a reason of cardiac arrest
- •PCI with stent implantation
- •Provision of informed consent prior to any study specific procedures is impossible because subjects are unconscious at the moment of inclusion
排除标准
- •Use of any P2Y12 inhibitors in last 10 days
- •Use of prasugrel before and 48 hours after loading dose of P2Y12 inhibitor
- •Use of eptifibatide before and 48 hours after loading dose of P2Y12 inhibitor
- •Thrombocytopenia (<50*109/L)
- •Allergic reaction to acetylsalicylic acid, clopidogrel or ticagrelor
- •Ticagrelor contraindications: previous intracranial bleeding, active pathological bleeding, moderate to severe hepatic impairment, heart rate < 40/min at presentation
- •Suspected or confirmed pregnancy
- •Use of bivalirudin before and 48 hours after loading dose of P2Y12 inhibitor
研究组 & 干预措施
Clopidogrel
These patients will be treated with clopidogrel 600 mg loading and than 75 mg/24 h.
干预措施: Clopidogrel (Drug)
Ticagrelor
These patients will be treated with ticagrelor 180 mg loading and than 90 mg/12 h.
干预措施: Ticagrelor (Drug)
结局指标
主要结局
VerifyNow P2Y12Test - Platelet Reactivity
时间窗: 12 h after P2Y12 inhibitor loading
Platelet reactivity reflects P2Y12 inhibitor effect. Higher values mean normal platelet reactivity due to low P2Y12 inhibition response, while lower values mean decreased platelet reactivity due to the effect of a P2Y12 inhibitor. High on-treatment platelet reactivity was defined as \>208 PRU.
次要结局
- Multiplate ADP Test(12 hours after P2Y12 inhibitor loading)
- VerifyNow P2Y12Test - % Inhibition(12 hours after P2Y12 inhibitor loading)
研究者
Marko Noc
Marko Noc, MD, PhD
University Medical Centre Ljubljana