Evaluating the benefit of additional platelet inhibition in acute coronary syndrome patients with high platelet reactivity undergoing PCI - APACS-HPR Trial

Phase 1

• Conditions: Cardiovascular disease - Acute coronary syndrome

• Registration Number: EUCTR2010-020219-35-GB
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-30
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

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
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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
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 anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified