Study to evaluate treatment with Prasugrel or Clopidogrel High Dose Regimen in patients who do not respond fully to Clopidogrel Standard Dose Regimen.

• Conditions: Cardiovascular disease- Acute coronary syndrome; MedDRA version: 14.1Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-05
• Last Update Posted: 24 February 2014

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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

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 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

Study & Design

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