A Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease: 2nd Switching Antiplatelet Agents
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 13
- 主要终点
- P2Y12 Reaction Units
研究概览
简要总结
This is a Phase 4, multicenter, open-label (blinded Pharmacodynamic PD results), randomized, 3-arm, parallel-design study of subjects with stable Coronary Artery Disease CAD. This study will compare the PD effect of prasugrel 10 mg QD (once-daily) maintenance dose with ticagrelor 90 mg BID (twice daily) maintenance dose in subjects with stable CAD who have previously received ticagrelor loading does (LD) and maintenance dose (MD)..
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female; age >= 18 and < 75 years
- •Weight >= 60 kg
- •Receiving low dose ASA (75 mg to 150 mg daily) for at least 7 days at the time of Visit 1 and able to continue the same regimen throughout the study
- •Stable CAD. CAD is defined as any of the following:
- •History of a positive stress test
- •Previous coronary revascularization including percutaneous coronary intervention (PCI), stent, or coronary artery bypass graft (CABG)
- •Angiographic demonstration of CAD (at least
- •1 lesion >= 50 percent)
- •Presence of at least moderate plaque by computed tomography (CT) angiography
- •Electron beam CT coronary artery calcification score >= 100 Agatston units
- •If female, may be enrolled if
- •One of the following 3 criteria are met:
- •Had a hysterectomy or tubal ligation at least 6 months prior to signing the informed consent form (ICF)
- •Post-menopausal for at least 1 year
- •If of childbearing potential, will practice 1 of the following methods of birth control throughout the study: oral, injectable, or implantable hormonal contraceptives; intrauterine device; diaphragm plus spermicide; or female condom plus spermicide. Methods of contraception that are not acceptable are partner's use of condoms or partner's vasectomy
- •Able and willing to provide written informed consent before entering the study
排除标准
- •Have a defined need for adenosine diphosphate (ADP)-receptor inhibitor therapy, such as any of the following (or any other condition that in the Investigator's judgment would require such therapy):
- •Within =< 12 months of an acute coronary syndrome (ACS) event (unstable angina [UA], non-ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]) regardless of initial treatment (that is, invasive versus noninvasive)
- •Subjects who underwent angioplasty within 12 months including bare-metal stent and/or a drug-eluting stent
- •Had any stent placed in an unprotected left main coronary artery or in the last patent artery within the last 12 months
- •Received thienopyridine therapy within 30 days of study entry
- •Plan to undergo coronary revascularization at any time during the trial
- •Presence or history of any of the following: ischemic or hemorrhagic stroke; transient ischemic attack (TIA); intracranial neoplasm; arteriovenous malformation, or aneurysm; intracranial hemorrhage; head trauma (within 3 months of study entry)
- •History of refractory ventricular arrhythmias with an increased risk of bradycardic events (eg, subjects without a pacemaker who have sick sinus syndrome, 2nd or 3rd degree atrioventricular (AV) block or bradycardic-related syncope)
- •History or evidence of congestive heart failure (New York Heart Association Class III or above =< 6 months before screening
- •Severe hepatic impairment
- •History of uric acid nephropathy
- •Uncontrolled hypertension, or systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg at screening
- •Severely impaired renal function (glomerular filtration rate < 30 mL/minute) or on dialysis
- •At risk for bleeding
- •Taking prohibited medications
研究组 & 干预措施
Prasugrel Maintenance Dose
Prasugrel 10 mg QD MD
干预措施: Prasugrel Maintenance Dose (Drug)
Ticagrelor Maintenance Dose
Ticagrelor 90 mg twice-daily (BID) MD
干预措施: Ticagrelor Maintenance Dose (Drug)
Prasugrel Loading Dose
Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)
干预措施: Prasugrel Loading Dose (Drug)
Prasugrel Loading Dose
Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)
干预措施: Prasugrel Maintenance Dose (Drug)
结局指标
主要结局
P2Y12 Reaction Units
时间窗: 7 days after first randomized dose
P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay VerifyNow P2Y12 assay, developed by Accumetrics, Inc. (San Diego, CA, USA), has been approved by the FDA to assess clopidogrel response using whole blood in a point-of-care testing fashion. Platelet aggregation with this system is defined by PRU, with a higher PRU indicative of greater platelet aggregation, and a lower PRU indicative of inhibition.
次要结局
- Platelet Reactivity Index(2, 4, 24, 48 hours, 7 days after first randomized dose)
- PRU Percent Inhibition (Calculated)(2, 4, 24, 48 hours, 7 days after first randomized dose)
- P2Y12 Reaction Units(2, 4, 24, 48 hours after first randomized dose)
- PRU Percent Inhibition (Device-reported)(2, 4, 24, 48 hours, 7 days after first randomized dose)
- Percentage of Subjects With High On-treatment Platelet Reactivity(2, 4, 24, 48 hours, 7 days after first randomized dose)