NCT04060914Unknown4 期
LOwer Maintenance Dose TICagrelor in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention
Beijing Anzhen Hospital1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2019年8月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Platelet reactivity index (PRI)
研究概览
简要总结
The hypothesis in this study was that ticagrelor switched to 60 mg after 1 month of standard dose, with antiplatelet activity that is not inferior to the standard dose and better than 75 mg clopidogrel for patients with ACS after PCI.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agree to sign the Informed Consent;
- •Male or female, ≥ 18 years of age, and ≤ 70 years of age
- •Patient presents with acute coronary syndrome (ACS)
- •Planned to undergo PCI
- •Planned to DAPT for 1 year after PCI
排除标准
- •Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 30 visit.
- •Patients cannot use ticagrelor or clopidogrel due to contraindications or other reasons.
- •Patients with active pathological hemorrhage or a history of intracranial hemorrhage
- •Patient unable to receive 12 months of dual anti-platelet therapy
- •Patient developing procedure-related complications such as stent thrombosis, coronary dissection, coronary perforation, cardiac tamponade or no-reflow during PCI
- •Patient or physician refusal to enroll in the study
- •History of intracranial hemorrhage
- •Patient has a history of bleeding diathesis or coagulopathy
- •Patient has an active pathological bleeding, such as active gastrointestinal (GI) bleeding
- •Patient is pregnant, breastfeeding, or planning to become pregnant within 12 months
- •Patient is receiving chronic oral anticoagulation therapy (i.e., vitamin K antagonist, direct thrombin inhibitor, Factor Xa inhibitor)
- •Patient with cardiogenic shock or mechanical circulatory assist devices placed
- •Patient with active liver diseases
- •Patient with severe renal insufficiency (eGFR <30ml/min/1.73m2 based on simplified MDRD equation or CrCl <30ml/min based on Cockcroft-Gault equation)
- •Patient has a malignancy or a life expectancy of less than one year
- •Platelet count <100 000/μL, or hematocrit <32% or >52%, or white blood cell count <3000/μL
- •Any other condition deemed by the investigator to place the patient at excessive risk of bleeding with ticagrelor
研究组 & 干预措施
Ticagrelor(90mg)
Experimental
干预措施: Ticagrelor 90mg (Drug)
Ticagrelor(90/60mg)
Experimental
干预措施: Ticagrelor 90mg/60mg (Drug)
Clopidogrel(75mg)
Active Comparator
干预措施: Clopidogrel 75mg (Drug)
结局指标
主要结局
Platelet reactivity index (PRI)
时间窗: 90 days (±14)
Platelet reactivity of ticagrelor or clopidogrel MD will be measured as PRI% using whole blood vasodilator-stimulated phosphoprotein (VASP) at 90 days after PCI.
次要结局
- The platelet aggregation ratio(90 days (±14))
- Plasma adenosine concentration(90 days (±14))
- Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE)(1 year)
研究者
Lin Yang
PHD
Beijing Anzhen Hospital
研究点 (1)
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