A Randomized Controlled Trial on the Switch From Ticagrelor to Clopidogrel in Acute Coronary Syndrome Patients After Percutaneous Coronary Intervention--OPTImal Management of Antithrombotic Agents: OPTIMA-5
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change of platelet aggregation between different time points
研究概览
简要总结
This is a prospective, randomized, open-label clinical trial which will enroll 80 acute coronary syndrome (ACS) patients after Percutaneous Transluminal Coronary Intervention (PCI) in China. Patients on maintenance dosing (MD) of aspirin (100 mg/d) and ticagrelor (90 mg twice daily) will be divided into two groups switching from ongoing ticagrelor to clopidogrel 600 mg loading dose (LD)/ 75 mg MD according to their bleeding risk. Then each group will randomly switch at different times(24 hours/ 12 hours after the last MD of ticagrelor). Pharmacodynamic assessments are performed at baseline, and at 4h, 8h, 24h, 48h, 72h hours with platelet aggregation rate by Light Transmittance Aggregometry method (LTA). All patients are followed-up for 30 days.
详细描述
The primary endpoint of the study was platelet inhibition measured by Light Transmittance Aggregometry method(LTA). Secondary clinical endpoints included a 30-day major adverse cardiovascular endpoint (MACE) defined as a composite of cardiovascular death, recurrent myocardial infarction, target vessel revascularisation or stroke and individual components of the MACE. Safety endpoints of 30-day TIMI major and minor bleed were also evaluated.
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
- •≥ 18 years.
- •ACS patients.
- •Patients who are treated with ticagrelor and do not tolerate it.
- •Volunteer to participate and sign informed consent.
- •Approved by national regulatory authorities ethics committees.
排除标准
- •Patients who are contraindicated, intolerant or resistant to clopidogrel.
- •History of hematological disease or bleeding tendency; platelet count < 100 × 10^9 cells/L, or > 600 × 10^9 cells/L, hemoglobin < 100 g/L.
- •Abnormal liver or kidney function (ALT > 3 ULN; estimated CrCl < 30 ml/min calculated by Cockcroft-Gault equation); diagnosed severe pulmonary disease.
- •Patients in need of drugs which affect the efficacy of clopidogrel such as miconazole, ketoconazole, andfluconazole.
- •Malignancies or other comorbid conditions with life expectancy less than 1 year.
- •Pregnant or lactating woman.
研究组 & 干预措施
clopidogrel-600 mg-12h
clopidogrel 600 mg loading dose (LD) 12 hours after the last maintenance dose（MD） of ticagrelor followed by 75 mg MD daily
干预措施: Switch ticagrelor to clopidogrel (Drug)
clopidogrel-600 mg-24h
clopidogrel 600 mg loading dose (LD) 24 hours after the last maintenance dose（MD） of ticagrelor followed by 75 mg MD daily
干预措施: Switch ticagrelor to clopidogrel (Drug)
clopidogrel-75 mg-12h
clopidogrel 75 mg maintenance dose(MD) 12 hours after the last MD of ticagrelor
干预措施: Switch ticagrelor to clopidogrel (Drug)
clopidogrel-75 mg-24h
clopidogrel 75 mg maintenance dose（MD) 24 hours after the last MD of ticagrelor
干预措施: Switch ticagrelor to clopidogrel (Drug)
结局指标
主要结局
Change of platelet aggregation between different time points
时间窗: baseline,4 hours,8 hours,24 hours,48 hours,72 hours
Regional differences between blood samples from each subjects of different groups by LTA.The results of LTA are reported in platelet aggregation rate(%).Platelet aggregation was induced by0.5mg/ml arachidonic acid (AA).
次要结局
- Rate of clinical endpoint event(30 days)
研究者
Chunjian Li
Dr., MD, Ph.D, Director of CCU Ward
The First Affiliated Hospital with Nanjing Medical University