Prasugrel Or Ticagrelor De-escalation in Non-ST-elevation Acute Coronary Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Platelet Reactivity Assessed with Multiple Electrode Aggregometry
研究概览
简要总结
The PROTEUS study is a randomized, cross-over, open-label, pharmacodynamic trial designed to compare the antiplatelet effect of reduced maintenance doses of prasugrel and ticagrelor in stable patients who recently had non-ST-elevation acute coronary syndrome (non-ST-elevation myocardial infarction or unstable angina).
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
- None
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
- •provision of informed consent prior to any study specific procedures
- •diagnosis of non-ST-segment elevation acute coronary syndrome (non-ST-segment elevation myocardial treatment or unstable angina)
- •male or non-pregnant female, aged 18-75 years old
排除标准
- •known hypersensitivity to ticagrelor or prasugrel
- •presence of contraindications for ticagrelor or prasugrel
- •current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin
- •history of ischemic stroke or transient ischemic attack
- •history of intracranial hemorrhage
- •recent gastrointestinal bleeding (within 30 days)
- •history of moderate or severe hepatic impairment
- •history of major surgery or severe trauma (within 3 months)
- •patient required dialysis
- •concomitant therapy with strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir) or strong CYP3A inducers (rifampicin, phenytoin, carbamazepine, dexamethasone, phenobarbital) within 14 days and during study treatment
- •body weight below 60 kg
研究组 & 干预措施
Initial ticagrelor
All patients will receive standard 180 mg loading dose of ticagrelor, followed by a standard maintenance dose of 90 mg bid for 30 days, after which de-escalation to 60 mg bid will take place and this dosing will be maintained for 15 days. At day 45 all patients will be loaded with standard 60 mg dose of prasugrel followed by reduced maintenance dose of 5 mg qd for 15 days. At day 60 all patients will be switched back to guideline recommended antiplatelet therapy.
干预措施: De-escalation to ticagrelor 60 mg at day 30 (Drug)
Initial ticagrelor
All patients will receive standard 180 mg loading dose of ticagrelor, followed by a standard maintenance dose of 90 mg bid for 30 days, after which de-escalation to 60 mg bid will take place and this dosing will be maintained for 15 days. At day 45 all patients will be loaded with standard 60 mg dose of prasugrel followed by reduced maintenance dose of 5 mg qd for 15 days. At day 60 all patients will be switched back to guideline recommended antiplatelet therapy.
干预措施: Switch to prasugrel 5 mg at day 45 (Drug)
Initial prasugrel
All patients will receive standard 60 mg loading dose of prasugrel, followed by a standard maintenance dose 10 mg qd for 30 days, after which de-escalation to 5 mg qd will take place and this dosing will be maintained for 15 days. At day 45 patients will be loaded with standard 180 mg dose of ticagrelor followed by reduced maintenance dose of 60 mg bid for 15 days. At day 60 all patients will be switched back to guideline recommended antiplatelet therapy.
干预措施: De-escalation to prasugrel 5 mg at day 30 (Drug)
Initial prasugrel
All patients will receive standard 60 mg loading dose of prasugrel, followed by a standard maintenance dose 10 mg qd for 30 days, after which de-escalation to 5 mg qd will take place and this dosing will be maintained for 15 days. At day 45 patients will be loaded with standard 180 mg dose of ticagrelor followed by reduced maintenance dose of 60 mg bid for 15 days. At day 60 all patients will be switched back to guideline recommended antiplatelet therapy.
干预措施: Switch to ticagrelor 60 mg at day 45 (Drug)
结局指标
主要结局
Platelet Reactivity Assessed with Multiple Electrode Aggregometry
时间窗: day 15 of using reduced maintenance dose of prasugrel or ticagrelor
Platelet Reactivity Assessed with Multiple Electrode Aggregometry will be evaluated after 15 days of using reduced maintenance dose of prasugrel or ticagrelor.
次要结局
- High Platelet Reactivity according to Multiple Electrode Aggregometry(day 15 of using reduced maintenance dose of prasugrel or ticagrelor)
- High Platelet Reactivity according to the VerifyNow assay(day 15 of using reduced maintenance dose of prasugrel or ticagrelor)
- Platelet Reactivity Assessed with the VerifyNow assay(day 15 of using reduced maintenance dose of prasugrel or ticagrelor)
研究者
Piotr Adamski
MD, PhD, Associate Professor
Collegium Medicum w Bydgoszczy