Standard (180mg) Versus Double (360mg) Loading Dose of Ticagrelor in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
Standard (180mg) Versus Double (360mg) Loading Dose of Ticagrelor in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI): a Multi-center Randomized Parallel Pharmacodynamic Study.
This is a multi-center, prospective, randomized, single-blind, investigator initiated, pharmacodynamic study of parallel design, performed at 3 institutions (Patras University Hospital; Evangelismos Athens General Hospital; Gennimatas Athens General Hospital).
Patients with ST elevation myocardial infarction (symptom onset < 12 hours), undergoing primary percutaneous coronary intervention, who are antiplatelet naïve (Group A) or present high residual PR (defined as PRU ≥ 208) immediately before primary percutaneous coronary intervention, will be randomized after informed consent, in a 1:1 ratio to either:
Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD )starting 12±6 hours post LD Or Ticagrelor 360mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD) starting 12±6 hours post LD Platelet reactivity assessment will be performed at randomization (Hour 0) and at 0.5, 1, 2, 4 hours after randomization, using the VerifyNow assay, in platelet reactivity units (PRU).
Documentation of major adverse cardiac events (death, myocardial infarction, stroke, urgent revascularization procedure with PCI or CABG) and bleeding (according to Bleeding Academic Research Consortium criteria) will be performed until patient's discharge.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Achaia
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Rio、Achaia、希腊、26500
- Cardiology Department Patras University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age ≥ 18 years old
- Patients with STEMI (onset of pain < 12 hours) with indication for primary PCI
- Antiplatelet naïve or presenting HTPR (≥ 208 PRU) immediately before primary percutaneous coronary intervention
- Informed consent obtained in writing
Exclusion Criteria
- Pregnancy
- Breastfeeding
- Inability to give informed consent or high likelihood of being unavailable until the Day 5
- Cardiogenic shock
- Major periprocedural complications (death, stent thrombosis, vessel perforation, arrhythmias requiring cardioversion, temporary pacemaker insertion or intravenous antiarrhythmic agents, respiratory failure requiring intubation, vascular injury (arteriovenous shunt, retroperitoneal bleeding), major bleeding (need for bood transfusion or drop in haemoglobin post-PCI by ≥ 5 gr/ dl or intracranial bleeding).
- Unsuccessful PCI (residual stenosis > 30% or flow < ΤΙΜΙ 3)
- Known hypersensitivity to ticagrelor
- History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months.
- Other bleeding diathesis, or considered by investigator to be at high risk for bleeding
- Any previous history of stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
- Thrombocytopenia (< 100.000/μL) at randomization
- Anaemia (Hct < 30%) at randomization
- Polycytaemia (Hct > 52%) at randomization
- Periprocedural IIb/IIIa inhibitors administration
- Thrombolysis administration
- Recent (< 6 weeks) major surgery or trauma, including GABG.
- Subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study.
- Concomitant oral or IV therapy with strong CY P3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazana vir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3A inducers (rifampin/rifampicin, phenytoin, carbamazepine).
- Increased risk of bradycardiac events.
- Dialysis required.
- Severe uncontrolled chronic obstructive pulmonary disease
- Known severe hepatic impairment
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:Ticagrelor 180mg loading dose
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Ticagrelor 360mg loading dose immediately pre prior percutaneous coronary intervention 360mg loading dose
Ticagrelor 180mg loading dose 180mg loading dose
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实验性的:Ticagrelor 360mg loading dose
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Ticagrelor 360mg loading dose immediately pre prior percutaneous coronary intervention 360mg loading dose
Ticagrelor 180mg loading dose 180mg loading dose
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
platelet reactivity at 1 hour post randomization in Group A, between the 2 treatment arms.
大体时间:1 hour
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platelet reactivity at 1 hour post randomization in Group A, between the 2 treatment arms.
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1 hour
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
1. Platelet reactivity at 1 hour post randomization in Group B, between the 2 treatment arms.
大体时间:1 hour
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1. Platelet reactivity at 1 hour post randomization in Group B, between the 2 treatment arms.
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1 hour
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2. Platelet reactivity at 0.5 hour post randomization between the 2 treatment arms separately for Group A and B
大体时间:0.5 hour
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Platelet reactivity at 0.5 hour post randomization between the 2 treatment arms separately for Group A and B
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0.5 hour
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Platelet reactivity at 2 hours post randomization between the 2 treatment arms separately for Group A and B
大体时间:2 hours
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Platelet reactivity at 2 hours post randomization between the 2 treatment arms separately for Group A and B
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2 hours
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Platelet reactivity at 4 hours post randomization between the 2 treatment arms separately for Group A and B
大体时间:4 hours
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Platelet reactivity at 4 hours post randomization between the 2 treatment arms separately for Group A and B
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4 hours
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3. High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 0.5 hour post randomization between the 2 treatment arms, separately for Group A and B
大体时间:0.5 hour
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High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 0.5 hour post randomization between the 2 treatment arms, separately for Group A and B
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0.5 hour
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High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 1 hour post randomization between the 2 treatment arms, separately for Group A and B
大体时间:1 hour
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High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 1 hour post randomization between the 2 treatment arms, separately for Group A and B
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1 hour
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High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 2 hours post randomization between the 2 treatment arms, separately for Group A and B
大体时间:2 hours
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High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 2 hours post randomization between the 2 treatment arms, separately for Group A and B
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2 hours
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High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 4 hours post randomization between the 2 treatment arms, separately for Group A and B
大体时间:4 hours
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High on treatment platelet reactivity (HTPR) rates (≥208 PRU) at 4 hours post randomization between the 2 treatment arms, separately for Group A and B
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4 hours
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Occurrence of any 5-day bleeding event (BARC Types 1-5)
大体时间:5 days
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Occurrence of any 5-day bleeding event (BARC Types 1-5)
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5 days
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Occurrence of 5-day MACEs
大体时间:5 days
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Occurrence of 5-day MACEs
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5 days
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合作者和调查者
调查人员
- 首席研究员:Dimitrios Alexopoulos, MD、University Hospital of Patras
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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