Mojito Study (Mashed Or Just Integral Pill of TicagrelOr ? )
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Residual Platelet Reactivity
研究概览
简要总结
The aim of the Mashed Or Just Integral pill of TicagrelOr (MOJITO) study is to evaluate the superiority of Ticagrelor 180 mg LD mashed pill versus Ticagrelor 180 mg LD integral pill both orally administrated in decreasing residual platelet reactivity 1 hour after the administration among 70 patients with STEMI (ST segment elevation myocardial infarction) undergoing PPCI (primary percutaneous coronary intervention) with bivalirudin monotherapy.
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
- •Patients presenting within 12 hours from the onset of symptoms with STEMI
- •Informed, written consent
排除标准
- •Age < 18 years or Age > 75 years
- •Active bleeding; bleeding diathesis; coagulopathy
- •Increased risk of bradycardiac events
- •History of gastrointestinal or genitourinary bleeding <2 months
- •Major surgery in the last 6 weeks
- •History of intracranial bleeding or structural abnormalities
- •Suspected aortic dissection
- •Any other condition that may put the patient at risk or influence study results or investigator's opinion (severe hemodynamic instability, known malignancies or other comorbid conditions with life expectancy <1 year)
- •Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux .
- •Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers, CYP3A with narrow therapeutic windows
- •Known relevant hematological deviations: Hb <10 g/dl, Thrombi. <100x10^9/l
- •Use of coumadin derivatives within the last 7 days
- •Chronic therapy with ticagrelor, prasugrel, clopidogrel or ticlopidine
- •Known severe liver disease, severe renal failure
- •Known allergy to the study medications
- •Pregnancy
研究组 & 干预措施
Ticagrelor mashed pills
Ticagrelor loading dose (LD) 180 mg as mashed pills
干预措施: Ticagrelor mashed pills (Drug)
Ticagrelor integral pills
Ticagrelor loading dose (LD) 180 mg as integral pills
干预措施: Ticagrelor integral pills (Drug)
结局指标
主要结局
Residual Platelet Reactivity
时间窗: 1 hour
residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD.
次要结局
- Bleeding Events(48 hours)
- High Residual Platelet Reactivity(1 hour)
- Dyspnoea and/or Symptomatic Bradycardia(6 months)
研究者
David Antoniucci
Director, Division of Invasive Cardiology
Careggi Hospital