Evaluating the Benefit of Additional Platelet Inhibition in Acute Coronary Syndrome Patients With High Platelet Reactivity Undergoing PCI
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Platelet Reactivity
研究概览
简要总结
Patients admitted to hospital with chest pain due to reduced blood flow to heart muscle (diagnosis Acute Coronary Syndrome) can be treated with medication and an angioplasty ± stent procedure, which restores blood flow to the heart. Antiplatelet drugs (Aspirin and Clopidogrel) are blood thinning treatments and research has reported they reduce heart attacks, death and stroke. The investigators know some patients do not respond fully to Clopidogrel but currently patients are not tested for this.
The investigators wish to perform a trial to identify those patients who do not respond fully to Clopidogrel and randomise them to either Prasugrel (newer drug) or a higher dose of Clopidogrel.
Patients admitted to the hospitals (2 in the UK and 1 in Germany) will be asked for their consent to participate. A blood sample is tested for platelet activity.
- Low platelet activity result means patient has responded well to Clopidogrel and will continue on the routine dose. They will be entered into an observational registry. Data will be collected of routine blood tests and investigations, medication and procedures. Their GP will be contacted at about 30 days to see if they are alive.
- High platelet activity results means patient has not responded fully to Clopidogrel. These patients will be randomly allocated to a higher dose of Clopidogrel or new drug Prasugrel. Data will be collected of routine blood tests and investigations, medication and procedures. A hospital visit at 30±5 days is required to assess how patients are doing, medications and occurrence of any events.
详细描述
STUDY DESCRIPTION This is a multinational, randomised open label study comparing Prasugrel versus Clopidogrel in ACS patients who have high platelet reactivity managed with an early invasive strategy (PCI as early as possible and no later than 72 hours from admission).
Patients identified with low platelet reactivity indicating a good response to Clopidogrel will be entered into an observational Registry.
Sites There will be three participating hospitals, two in the UK and one in Germany.
Screening All patients admitted to the hospital with suspected ACS requiring early PCI (within 3 days of admission) will be screened for entry into the trial.
The investigator and/or his/her designee will explain the study requirements and procedures and obtain consent before any study procedures are performed.
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
- •ACS patients with intent for PCI <72 hours from admission.
- •Prior clopidogrel loading within 24h before planned PCI or chronic (>24 hours) treatment with clopidogrel
- •High platelet reactivity (HPR) PA > 400 AU min by multiplate analyser ("poor responders")
- •Initial platelet function sample at least 2 hours after pre PCI loading dose
排除标准
- •Patients <18 years and >75 years
- •Body weight <60kg
- •Pretreatment with prasugrel within 7 days of randomisation
- •History of stroke or transient ischaemic attack
- •Patients with increased bleeding risk e.g.
- •recent major trauma or surgery
- •gastrointestinal bleeding or active peptic ulceration
- •Platelet count <100,000 / mm3 at the time of screening
- •Internationally Normalized Ratio (INR)> 1.5 at the time of screening
- •Intracranial neoplasm, arteriovenous malformation or aneurysm.
- •Severe hepatic impairment (Child Pugh class C)
- •Intention to use the following medications
- •oral anticoagulation
- •other antiplatelet therapy (including GPIIb/IIIa inhibitors) besides aspirin
- •nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors
- •Female patients who are pregnant, planning pregnancy, not using reliable contraception or who are breastfeeding
- •Known allergy, hypersensitivity or other contraindications to prasugrel or clopidogrel
研究组 & 干预措施
Prasugrel
Day 1 loading 60mg Day 2 to 7 10mg o.d. Day 8 to 30 days 10mg od
干预措施: Prasugrel (Drug)
Clopidogrel
Day 1 Loading 600mg Day 2 to 7 day: 150mg o.d. Day 8 to 30 days: 75mg o.d.
干预措施: Plavix (Drug)
结局指标
主要结局
Platelet Reactivity
时间窗: 4 hours post loading dose
The primary endpoint will compare the proportion of patients with improved platelet response (i.e. decreased platelet reactivity under the cut-off value of 400 Au.min) in the prasugrel re-loading arm compared to the clopidogrel re-loading arm at 4 hours after randomization in patients with initial high platelet reactivity
次要结局
- Platelet reactivity in response to randomised study drug(7 days/hospital discharge and 30 days)
- Extent of myocardial damage(24 hours)
- MACE(30 days)
- Bleed(30 days)