Pharmacodynamic Evaluation of Antiplatelet Effect of Swallowing Versus Chewing Ticagrelor in Patients With Acute Coronary Syndrome
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Platelet reactivity
研究概览
简要总结
The study aims to determine the pharmacodynamic performance in the first hour measured with verifynow, of the conventional ticagrelor loaded dose versus chewed ticagrelor in patients with acute coronary syndrome treated with percutaneous coronary intervention
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
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients presenting to the emergency department with acute coronary syndrome for percutaneous coronary intervention
排除标准
- •Age <18 years
- •Known coagulopathy, bleeding diathesis, or active bleeding
- •History of recent gastrointestinal or genitourinary bleeding within 2 months
- •Previous therapy with clopidogrel, prasugrel, or ticagrelor
- •Previous treatment with glycoprotein IIb/IIIa inhibitors or during interventional procedure
- •Major surgery within 6 weeks
- •History of intracranial bleeding or intracraneal neoplasm
- •Suspected aortic dissection
- •Chronic obstructive pulmonary disease
- •Severe hemodynamic instability or cardiogenic shock
- •Resuscitated cardiac arrest
- •Use of vitamin K anticoagulants or novel oral anticoagulants (NOACs) within 7 days
- •Life expectancy <1 year
- •Known severe liver or renal disease, GFR estimated by CKD-EPI <30 ml/min/1.73 m2
- •Known HIV treatment
- •Hemoglobin <10 g/dL
- •Platelet count <100,000/L
- •Pregnancy
- •Known allergy to ticagrelor
- •Refusal to sign informed consent
研究组 & 干预措施
Chewed ticagrelor
Ticagrelor pills. The 180 mg loading dose will be administered as soon as possible by investigation staff after a baseline VerifyNow measurement and after signed informed consent. Patients will be asked to chew, but not to swallow, during at least 40 seconds in presence of investigation staff.
Drug: ticagrelor (Brilinta) 90 mg tablets, 2 tablets chewed
干预措施: Chewed ticagrelor (Drug)
Swallowed ticagrelor
Ticagrelor integral tablet. The 180 mg loading dose will be administered as soon as possible by investigation staff after a baseline VerifyNow measurement is drawn. Patients will swallow the loading dose followed by 25-40 ml of water.
Drug: ticagrelor (Brilinta) 90 mg tableta, 2 tablets swallowed
干预措施: Swallowed ticagrelor (Drug)
结局指标
主要结局
Platelet reactivity
时间窗: 1 hour
Platelet reactivity measured with VerifyNow (PRU)
次要结局
- Efficacy (long term)(1 year)
- Efficacy (MACCE)(30 days)
- Composite outcome(30 days)
- High platelet reactivity on treatment rate(1 hour)