Ticagrelor in Comparison to Prasugrel for Early Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Platelet reactivity
研究概览
简要总结
This is a single-center, randomized, single-blind, investigator-initiated, pharmacodynamic study with a parallel design. Patients with ST elevation myocardial infarction, undergoing primary percutaneous coronary intervention will be randomized after informed consent, in a 1:1 ratio to the following treatment groups:
Group Α: Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD)starting 12±6 hours post LD, until Day 5 (5 days after randomization) Group Β: Prasugrel 60 mg LD followed by 10mg x1 MD starting 24 hours post LD, until Day 5 (5 days after randomization).
Platelet reactivity assessment will be performed at randomization (Hour 0) and at 1, 2, 6, 24 hours after randomization, and on Day 5. Documentation of major adverse cardiac events (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG)and serious adverse events (bleeding, other adverse events)will be performed until Day 5.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old
- •Patients with STEMI undergoing primary PCI with stenting
- •Informed consent obtained in writing
排除标准
- •Pregnancy
- •Breastfeeding
- •Inability to give informed consent or high likelihood of being unavailable until the Day 5
- •Prior PCI performed within 30 days prior to randomization
- •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) or planned staged PCI in the next 5 days after randomization
- •Requirement for oral anticoagulant prior to the Day 5 visit
- •Current or planned therapy with other thienopyridine class of ADP receptor inhibitors.
- •Known hypersensitivity to prasugrel or ticagrelor
- •History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
- •Other bleeding diathesis, or considered by investigator to be at high risk for bleeding.
- •Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
- •Thombocytopenia (<100.000 / μL) at randomization
- •Anaemia (Hct <30%) at randomization
- •Polycytaemia (Hct > 52%) at randomization
- •Periprocedural IIb/IIIa inhibitors administration
- •Severe allergy to contrast agent, unfractionated heparin, enoxaparin or bivalirudin that cannot be adequately premedicated.
- •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 impairement
研究组 & 干预措施
Prasugrel
Prasugrel 60mg LD followed by 10mg MD starting post 24 hours
干预措施: Prasugrel (Drug)
Ticagrelor
Ticagrelor 180mg LD followed by 90mg x2 MD starting post 12±6 hours
干预措施: Ticagrelor (Drug)
结局指标
主要结局
Platelet reactivity
时间窗: 1hour
Platelet reactivity Platelet assessed by VerifyNow P2Y12 assay 1 hour post randomization
次要结局
- Platelet reactivity(5 days)
研究者
Dimitrios Alexopoulos
Professor
University of Patras