A Randomized Controlled Trial of Patients Undergoing Percutaneous Coronary Intervention Who Receive Ticagrelor and Fentanyl
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Area Under the Platelet Function Testing (PFT)-Time Curve (AUC0-6) for the First 6 Hours After the Loading Dose of Ticagrelor
研究概览
简要总结
During a percutaneous coronary intervention (PCI), Fentanyl is commonly used for sedation. Ticagrelor is also routinely used as anti-platelet agent during PCI. However, a recent study has demonstrated the decrease in effectiveness of Ticagrelor when administered along with Fentanyl. Hence this study was designed to further assess the interaction between crushed vs non crushed Ticagrelor and Fentanyl given during PCI procedures.
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
- •Undergoing clinically indicated elective or non-elective PCI
- •Able to swallow oral medications
排除标准
- •Contraindications to ticagrelor or fentanyl (or other opiates)
- •Pregnancy
- •Any use of P2Y12 inhibitors within 14 days
- •Known coagulation disorders
- •Pre-procedural treatment with an anticoagulant (oral anticoagulant or low molecular weight heparin)
- •Platelet count < 100,000/mm3
- •Impaired renal function (Estimated glomerular filtration < 45 ml/min/1.73 m2)
- •Impaired hepatic function (Based on medical history)
- •Prior or planned transcatheter aortic valve replacement
研究组 & 干预措施
Fentanyl and Crushed Ticagrelor
Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered crushed (180 mg dose)
干预措施: Fentanyl (Drug)
Fentanyl and Crushed Ticagrelor
Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered crushed (180 mg dose)
干预措施: Ticagrelor 90Mg Tablet (Drug)
Fentanyl and Non-crushed Ticagrelor
Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered as a whole tablet (180 mg dose)
干预措施: Fentanyl (Drug)
Fentanyl and Non-crushed Ticagrelor
Premedicated with Fentanyl (at least 25mcg by IV) followed by Ticagrelor 90mg tablet administered as a whole tablet (180 mg dose)
干预措施: Ticagrelor 90Mg Tablet (Drug)
结局指标
主要结局
Area Under the Platelet Function Testing (PFT)-Time Curve (AUC0-6) for the First 6 Hours After the Loading Dose of Ticagrelor
时间窗: 6 hours after the loading dose of Ticagrelor
The Platelet Function Testing assay will be VerifyNow Platelet Reactivity Assay which is used institutionally. Results are reported in platelet reactive units (PRUs). Based on previous studies, 208 will be used as an estimated cutoff to distinguish therapeutic and subtherapeutic platelet inhibition, with PRUs equal to or less than 208 being considered therapeutic
次要结局
- In-Hospital Stent Thrombosis(From time of procedure until hospital discharge, up to 3 days)
- In-Hospital Thrombolysis in Myocardial Infarction (TIMI) Major and Minor Bleeding(From time of procedure until hospital discharge, up to 3 days)
- In-Hospital Recurrent Myocardial Infarction(From time of procedure until hospital discharge, up to 3 days)
- In-Hospital Stroke(From time of procedure until hospital discharge, up to 3 days)
- In-Hospital Death(From time of procedure until hospital discharge, up to 3 days)
- 30-Day Stent Thrombosis(30 days after hospital discharge)
- 30-Day TIMI Major and Minor Bleeding(30 days after hospital discharge)
- 30-Day Recurrent Myocardial Infarction(30 days after hospital discharge)
- 30-Day Stroke(30 days after hospital disharge)
- 30-Day All-cause Mortality (Death)(30 days after hospital discharge)