An Open Label, Two Arms, Randomized Controlled Pilot Study Comparing the Arachidonic Acid-induced Platelet Aggregation Rate in Patients With Stable Coronary Artery Disease Treated With Ticagrelor Monotherapy or Ticagrelor and Asprin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The rate of AA induced platelet aggregation
研究概览
简要总结
This study was a feasibility trial that was designed to provide preliminary observations and generate hypotheses for future studies. The aim of the study is to estimate the difference of arachidonic acid induced platelet aggregation rate between ticagrelor mono-therapy and aspirin/ticagrelor dual-therapy after 14 days of treatment in patients with stable coronary artery disease. The potential hypothesis is that the arachidonic acid (AA) induced platelet aggregation rate after 2 weeks of ticagrelor mono-therapy is comparable to that of aspirin/ticagrelor dual-therapy.
详细描述
This is a randomized, open labeled, active-controlled pilot study to estimate the difference of arachidonic acid induced platelet aggregation rate between ticagrelor monotherapy and aspirin/ticagrelor dual-therapy in patients with stable coronary heart disease. The anticipated duration of the study is approximately 9 months, including an anticipated enrolment period of 8 months and follow-up period of 4weeks.
Patients with documented coronary heart disease and currently receiving dual-antiplatelet therapy with standard dose aspirin and clopidogrel will be enrolled from the study site. For patients post acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI), they must be on dual-antiplatelet therapy for at least 12 months to be eligible for the study.
The study plan, including enrolment/randomization and follow-up visits, is outlined in Table 1. Eligible patients will enter a washout phase with ticagrelor for 2 weeks. Then they will be randomized to take either ticagrelor alone or aspirin/ticagrelor for 14 days. The efficacy evaluation will be done at 7 and 14days after randomization. The primary efficacy parameter is the rate of arachidonic acid induced platelet aggregation after 14 days of treatment. All patients will be treated to standards of care for coronary heart disease secondary prevention.
Visit 0 (Screening and Enrollment, 0 day) All potentially eligible patients will undergo a screening visit following their signed informed consent.
Following an 8-hour fast, the patients will have screening evaluations performed. Demography, medical history, and concomitant medication will be recorded. A physical examination and vital signs(pulse and BP), height and weight, as well as blood sampling for laboratory assessments of complete blood count (CBC) with differential, serum creatinine, alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and AA, adenosine diphosphate (ADP) and collagen induced platelet aggregation rate will be done. Standard 12-lead electrocardiogram (ECG) readings will be recorded.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures.
- •Aged >18 years.
- •Documented stable coronary artery disease.
- •Currently receiving dual-antiplatelet therapy with aspirin 100mg/d and clopidogrel 75mg/d.
排除标准
- •History of acute coronary syndrome within 12 months of screening.
- •History of percutaneous coronary intervention within 12 months of screening.
- •Any indication (eg, atrial fibrillation,prosthetic heart valve, or coronary stent) for antithrombotic therapy(eg, warfarin, clopidogrel, or aspirin dose other than 75 to 100 mg/during the study period).
- •AA induced platelet aggregation rate >20% on aspirin+clopidogrel measured by light transmission platelet aggregation test with the past 3 months.
- •Congestive heart failure or left ventricular ejection fraction <35%.
- •Forced expiratory volume in the first second forced vital capacity below the lower limits of normal.
- •Bleeding diathesis or severe pulmonary disease.
- •Active pathological bleeding.
- •History of intracranial hemorrhage.
- •Hypersensitivity to ticagrelor or any of the excipients.
- •Severe hepatic impairment.
- •Pregnancy.
- •Current smoking.
- •Platelet count <100 000/mm3 or hemoglobin <10 g/dL.
- •HemoglobinA1c >10%.
- •History of drug addiction or alcohol abuse in the past 2 years.
- •Need for nonsteroidal anti-inflammatory drug.
- •Creatinine clearance<30 mL/min.
- •Concomitant therapy with moderate or strong cytochrome P450 3A inhibitors, substrates, or strong cytochrome P450 3A inducers.
研究组 & 干预措施
ticagrelor mono-therapy
Take ticagrelor 90 mg Bid for 2 weeks.
干预措施: ticagrelor (Drug)
aspirin/ticagrelor dual-therapy
Take ticagrelor 90mg Bid plus Aspirin 100mg Qd and treated for 2 weeks.
干预措施: ticagrelor (Drug)
aspirin/ticagrelor dual-therapy
Take ticagrelor 90mg Bid plus Aspirin 100mg Qd and treated for 2 weeks.
干预措施: Aspirin (Drug)
结局指标
主要结局
The rate of AA induced platelet aggregation
时间窗: Day 14 after randomization
The rate of AA induced platelet aggregation will be measured at day 14 after randomization.
次要结局
- The rate of collagen induced platelet aggregation(Day 7 and day 14 after randomization)
- The serum concentration of Thromboxane B2(Day 7 and day 14 after randomization)
- The rate of ADP induced platelet aggregation(Day 7 and day 14 after randomization)
- The rate of AA induced platelet aggregation(Day 7 after randomization)
研究者
Yong Huo
The director of the Department of Cardiology and heart center of Peking University First Hospital
Peking University First Hospital