The Effects of Crushed Ticagrelor Versus Eptifibatide Bolus +Clopidogrel in Troponin-Negative ACS Patients Undergoing Coronary Intervention
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants With a Change in high-on Treatment Platelet Reactivity (HPR)
研究概览
简要总结
Patients with troponin-negative acute coronary syndrome (ACS) are not routinely pre-treated with P2Y12 inhibitors and the rate of high on-treatment platelet reactivity (HPR) remains elevated after a loading dose of ticagrelor at the time of percutaneous coronary intervention (PCI). This suggests that faster platelet inhibition with crushed ticagrelor , eptifibatide , or cangrelor is needed to reduce HPR and periprocedural myocardial infarction and injury (PMI). The present study compared the effects of crushed ticagrelor vs. eptifibatide bolus + clopidogrel in troponin-negative ACS patients undergoing PCI.
详细描述
Platelet activation and accumulation causes the formation of blood clots that may cause heart attack. As a standard of care, the doctor can prescribe medications such as are ticagrelor, eptifibatide, clopidogrel, to prevent the formation of blood clots.
100 patients with unstable angina, both male and female, will be randomized to either Group A- Crushed Ticagrelor or Group B- Eptifibatide bolus +Clopidogrel administrated immediately before PCI. Platelet function testing, troponin, and ECG will be performed.
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 with unstable angina/troponin negative ACS.
排除标准
- •need for oral anticoagulation therapy (Warfarin, Dabigatran, Rivaroxaban, Apixaban, Edoxaban)
- •increased risk of bradycardia, and the associated therapy with a strong cytochrome P-450 inhibitors (anti-retroviral agents, antifungal agents and some antibiotics eg. Indinavir, Nelfinavir, Lopinavir, Ritonavir, Itraconazole, Ketoconazole, Voriconazole, Clarithromycin, Telithormycin)
- •surgery<4 weeks
- •use of any thienopyridines (Clopidogrel, Prasugrel) 7 days prior to randomization
- •administration of GP IIb/IIIa inhibitors
- •bleeding diathesis or major bleeding episode within 2 weeks
- •thrombocytopenia (Platelet count < 100000)
- •incessant chest pain
- •hemodynamic instability (Mean arterial pressure < 65 mm Hg; need for vasopressor or inotropic agents; need for mechanical circulatory support for coronary intervention), NSTEMI as evidenced by elevation of troponin levels (Troponin > 0.034 ng/ml); renal failure with a serum creatinine >2.0 mg/dL
- •anemia with HCT<30%.
研究组 & 干预措施
Ticagrelor
crushed ticagrelor (180 mg); (n=50 patients)
干预措施: Ticagrelor (Drug)
Eptifibatide bolus+clopidogrel
Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients)
干预措施: Eptifibatide (Drug)
Eptifibatide bolus+clopidogrel
Eptifibatide bolus (180 mcg/kg x 2 boluses) + clopidogrel 600 mg and heparin low-dose (n=50 patients)
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Number of Participants With a Change in high-on Treatment Platelet Reactivity (HPR)
时间窗: 5 times (at baseline, and at 0.5, 2, 4, and 24 hours after loading dose)
We assessed platelet aggregation at baseline and during PCI by light transmission aggregomerty. The primary efficacy measure was HPR defined as platelet aggregation \>59% at 2 h measured by the Chronlog aggregometer after stimulation with ADP 20 µM.
次要结局
- Number of Participants With a Periprocedural Myocardial Infarction and Injury (PMI)(At baseline and every 8 hours post- PCI)
- Platelet Aggregation Levels(At baseline and at 0.5, 2, 4, and 24 hours after loading dose)
- Change in Hemoglobin Levels (g/dL)(At baseline and at 24 hours post-PCI)
- A Change in Hematocrit Levels(At baseline and at 24 hours post-PCI)
- Heparin Dose, Unit/Kg(24 hours after the PCI)
- Activated Clotting Time (ACT), Seconds(At the end of PCI)
- Number of Patients With Minor Bleeding Complications(At 1 year post-PCI)
- Number of Patients With Major Bleeding Complications(At 1 year post-PCI)
- Number of Patients With Negative Clinical Outcomes(At 1-year post-PCI)
研究者
Massoud Leesar
Principal Investigator
University of Alabama at Birmingham