Chewed Versus Integral Pill of Ticagrelor in All Patients Undergoing Percutaneous Coronary intervention--a Platelet Reactivity and Patient Outcomes Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Concentration of Pharmacodynamics
研究概览
简要总结
Hypothesis The primary question the investigators propose to answer is whether all patients undergoing percutaneous coronary intervention (PCI) with stent deployment who receive chewed ticagrelor will demonstrate more rapid drug absorption and decreased platelet reactivity as compared to integral pill form 1 hour after drug administration.
详细描述
Hypothesis The primary question the investigators propose to answer is whether all patients undergoing PCI with stent deployment who receive chewed ticagrelor will demonstrate more rapid drug absorption and decreased platelet reactivity as compared to integral pill form 1 hour after drug administration.
Secondary Hypotheses:
-
Major adverse cardiac and cerebrovascular event (MACCE) rate at 30 days and 1 year.
-
Death
-
Repeat myocardial infarction
-
Need for urgent revascularization
-
Cerebrovascular accident
-
Rate of stent thrombosis and in-stent stenosis at 30 days and 1 year.
-
Bleeding: Defined as major, minor, or minimal bleeding based on thrombolysis in myocardial infarction (TIMI) criteria.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients presenting to the cardiac catheterization lab for percutaneous coronary intervention.
排除标准
- •Age <18 years or Age >89 years
- •Known coagulopathy, bleeding diathesis, or active bleeding
- •History of recent gastrointestinal or genitourinary bleed within 2 months
- •Known chronic therapy with clopidogrel, prasugrel, or ticagrelor
- •Major surgery within last 6 weeks
- •History of intracranial bleed or intracranial neoplasm
- •Suspected aortic dissection
- •Severe hemodynamic instability, cardiogenic shock
- •Life expectancy <1 year
- •Known severe liver or renal disease
- •Known HIV treatment
- •Any use of Glycoprotein inhibitors (GP IIb-IIIa) 48-hours before the procedure or any use during the procedure
- •Any use of Cangrelor during or after the procedure
- •Hemoglobin <10 g/dL, platelet (PLT) <100x10^9/L
- •Pregnancy
- •Known allergy to study medication
研究组 & 干预措施
Experimental: Chewed ticagrelor
Drug: Ticagrelor chewed pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline P2Y12 platelet reaction units (PRU) level is drawn and before the end of the PCI. Patients will be asked to chew, but not swallow, allowing for sublingual absorption. (Loading dose 180mg)
干预措施: Ticagrelor (Drug)
Active Comparator: Integral pill
Drug: Ticagrelor integral pills. The loading dose will be administered as soon as possible by Catheterization Lab staff after a baseline P2Y12 platelet reaction units (PRU) level is drawn and before the end of the PCI. Patients will swallow the loading dose followed by 25-50mL (milliliter) of water. (180mg)
干预措施: Ticagrelor (Drug)
结局指标
主要结局
Concentration of Pharmacodynamics
时间窗: 1 hour
Platelet function was measured using the VerifyNow P2Y12 Assay (Accumetrics, San Diego, CA). This test is a turbidimetric-based optical detection system that measures ADP (Adenosine diphosphate) - induced platelet agglutination using a proprietary algorithm to report values in PRU.
次要结局
- Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE)(1 year)