EUCTR2010-020219-35-GB
Active, not recruiting
Phase 1
Evaluating the benefit of additional platelet inhibition in acute coronary syndrome patients with high platelet reactivity undergoing PCI - APACS-HPR Trial
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cardiovascular disease - Acute coronary syndrome
- Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Enrollment
- 140
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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