NCT01642940已完成4 期
Τicagrelor Versus Prasugrel in Diabetic Patients: a Pharmacodynamic Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Platelet reactivity
研究概览
简要总结
This is a prospective, randomized, single-center, single blind, investigator initiated, two period study of crossover design. Diabetic patients with Acute Coronary Syndrome (ACS), treated with oral and/or parenteral hypoglycaemic therapy for at least 1 month and subjected to percutaneous coronary intervention (PCI), will be randomized after a baseline platelet reactivity (PR) assessment (24 hours post PCI) while under clopidogrel in a 1:1 ratio to either prasugrel 10mg or ticagrelor 180mg for 15 days followed by crossover directly to the alternate therapy for an additional 15 days without an intervening washout period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years
- •Diabetic patients treated with oral and/or parenteral hypoglycaemic therapy for at least 1 month
- •Patients with acute coronary syndrome subjected to PCI with a baseline PR evaluation 24 hours post PCI while on clopidogrel
- •Informed consent obtained in writing
排除标准
- •Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 30 visit.
- •Pregnancy
- •Breastfeeding
- •Inability to give informed consent or high likelihood of being unavailable for the Day 30 follow up.
- •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 (pseudoaneurysm, arteriovenous shunt, retroperitoneal bleeding or hematoma >5 cm at the arterial catheter insertion site), 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 30 days after randomization
- •Requirement for oral anticoagulant prior to the Day 30 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 on longterm thienopyridine therapy.
- •Any previous history of ischemic 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
- •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.
- •Age ≥ 75 years
- •Weight < 60 Kg
- •Severe hepatic impairment
- •Severe uncontrolled chronic obstructive pulmonary disease
研究组 & 干预措施
Prasugrel
Active Comparator
干预措施: Prasugrel (Drug)
Ticagrelor
Experimental
干预措施: Ticagrelor (Drug)
结局指标
主要结局
Platelet reactivity
时间窗: 15 days
The primary outcome will be assessed 15 days after the onset of each study drug by the VerifyNow (Accumetrics)assay in platelet reactivity units (PRU)
次要结局
- Hyporesponsiveness rate (PRU≥230) at the end of the 2 treatment periods(Day 15)
研究者
Dimitrios Alexopoulos
Professor of Cardiology, Director of Cardiology Department
University of Patras
研究点 (1)
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