EUCTR2010-020219-35-DE进行中（未招募）不适用
Evaluating the benefit of additional platelet inhibition in acute coronary syndrome patients with high platelet reactivity undergoing PCI - APACS-HPR
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •PATIENT INCLUSION CRITERIA REGISTRY
- •a) ACS patients with intent for PCI <72 hours from admission.
- •b) Prior clopidogrel loading within 24h before planned PCI or chronic (>24 hours) treatment with clopidogrel
- •c) Low platelet reactivity (HPR) PA <400 AU min by multiplate analyser (good responders”). Blood sample to be taken
- •at least 2 hrs after prior clopidogrel loading.
- •d) Consent.
- •PATIENT INCLUSION CRITERIA FOR RANDOMISED APACS STUDY
- •a) ACS patients with intent for PCI <72 hours from admission.
- •b) Prior clopidogrel loading within 24h before planned PCI or chronic (>24 hours) treatment with clopidogrel.
- •c) High platelet reactivity (HPR) PA =400 AU min by multiplate analyser (poor responders”).
- •d) Initial platelet function sample at least 2 hours after pre PCI loading dose
- •e) Consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •PATIENT EXCLUSION CRITERIA RANDOMISED APACS STUDY
- •a) Patients <18 years and =75 years
- •b) Body weight <60kg
- •c) Pretreatment with prasugrel within 7 days of randomisation
- •d) History of stroke or transient ischaemic attack
- •e) 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
- •f) Hb<10g/dL
- •g) Intracranial neoplasm, arteriovenous malformation or aneurysm.
- •h) Severe hepatic impairment (Child Pugh class C)
- •i) Intention to use the following medications
- •oral anticoagulation
- •other antiplatelet therapy (including GPIIb/IIIa inhibitors) besides aspirin
- •nonsteroidal antiinflammatory
- •drugs (NSAIDs) or cyclooxygenase2 (COX2) inhibitors
- •j) Female patients who are pregnant, planning pregnancy, not using reliable contraception or who are breastfeeding
- •k) Known allergy, hypersensitivity or other contraindications to prasugrel or clopidgrel
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