Revacept, a Novel Inhibitor of Platelet Adhesion in Patients With Stable Coronary Artery Disease Undergoing Elective Percutaneous Coronary Interventions: a Phase II, Multicentre, Randomised, Double-blind and Placebo-controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 334
- 试验地点
- 8
- 主要终点
- Primary endpoint-composite endpoint of death and myocardial injury
研究概览
简要总结
The main objective is to evaluate the efficacy and safety of treatment with 2 doses (80 and 160 mg) of Revacept versus placebo in patients with stable coronary artery disease undergoing PCI.
详细描述
Revacept is a protein that is made up of an Fc fragment ("fragment crystallisable") fused to the GPVI receptor (the endogenous platelet collagen receptor). Consequently, Revacept binds to its ligand (collagen) on atherosclerotic plaques preventing circulating thrombocytes from binding to collagen exposed by the injured plaque. All this is achieved without affecting systemic hemostasis.
Thus, blocking of GPVI-dependent pathways by interfering with vascular collagen sites is commonly seen as an attractive target for an anti-platelet therapy of atherosclerotic diseases.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Signed written informed consent
- •Men and women >18 years of age
- •Diagnosis: Clinically stable coronary artery disease
- •Angiographic evidence of coronary artery disease
- •Indication for PCI
排除标准
- •WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 4 weeks after receiving investigational product.
- •Women who are pregnant or breastfeeding or are planning pregnancy during course of trial
- •Women with a positive pregnancy test on enrolment or prior to investigational product administration.
- •Patients with elevated high sensitivity cardiac troponin T levels at screening
- •Patients receiving antithrombotic therapy with Prasugrel or Ticagrelor within 7 days prior to randomisation
- •History of hypersensitivity, contraindication or serious adverse reaction to any component of the study drug (GPVI-Fc, sucrose, mannitol), acetylsalicylic acid or clopidogrel
- •History of bleeding diathesis or active bleeding within the last 30 days
- •Recent intracerebral haemorrhage or trauma within the last 3 months
- •Thrombocytopenia (platelet count <30000/mm3) at screening
- •Sustained hypertension (systolic BP >179mmHg or diastolic BP >109mmHg) at screening
- •Renal failure (estimated glomerular filtration rate < 30ml/min and/or dialysis)
- •Severe systemic disease, such as known malignancies or other comorbid conditions with life expectancy less than one year that may result in protocol non-compliance
- •Unable to provide informed consent (e.g. severe dementia, or psychosis)
- •Current severe liver dysfunction (transaminase level >5-fold the upper normal range limit)
- •Patients with an indication for anticoagulant therapy
- •Participation in any other clinical interventional trial (drug/device) within less than 30 days prior to screening
- •Any other contraindication to perform PCI
- •Any planned additional PCI or surgery within 30 days after randomization
- •Suspected poor capability to follow instructions and cooperate
- •Prisoners or subjects who are involuntarily incarcerated
- •Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness (e.g. infectious disease)
研究组 & 干预措施
Revacept 80 mg
single dose, intravenous
干预措施: Revacept 80 mg (Drug)
Revacept 160 mg
single dose, intravenous
干预措施: Revacept 160 mg (Drug)
Placebo
single dose, intravenous
干预措施: Placebo (Drug)
结局指标
主要结局
Primary endpoint-composite endpoint of death and myocardial injury
时间窗: within 48 hours from randomisation
A composite endpoint of death or myocardial injury (defined as increase in cardiac biomarker - high sensitivity cardiac troponin T of at least 5 times the upper limit of norm (ULN) within 48 hours from randomisation).
次要结局
- Myocardial infarction(within 30 days after randomisation)
- Bleeding class 2 or higher according to Bleeding Academic Research Consortium (BARC) criteria (safety endpoint)(within 30 days after randomisation)
- Urgent coronary revascularization(within 30 days after randomisation)
- Peak potprocedural high-sensitivity troponin T level(within 48 hours after randomisation)
- All cause mortality(within 30 days after randomisation)
- Definite stent thrombosis(within 30 days after randomisation)
- PCI-related (type 4) myocardial infarction(within 30 days after randomisation)
- Stroke(within 30 days after randomisation)