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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020219-35-GB

Enrollment

140

Registered

2011-03-30

Start date

2011-07-18

Completion date

Unknown

Last updated

2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease - Acute coronary syndrome

Interventions

Trade Name: Efient Product Name: Prasugrel Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Prasugrel (hydrochloride) CAS Number: 389574-19-0 Other descriptive name: Efient Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: PATIENT INCLUSION CRITERIA REGISTRY a) ACS patients with intent for PCI 24 hours) treatment with clopidogrel c) Low platelet reactivity (HPR) PA 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

Exclusion criteria: PATIENT EXCLUSION CRITERIA RANDOMISED APACS STUDY a) Patients 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

Design outcomes

Primary

Measure	Time frame
Main Objective: OBSERVATIONAL REGISTRY OF SCREENED PATIENTS To identify the proportion of patients who are good responders to routine doses of Clopidogrel and compare the events of death at 30 days. RANDOMISED PATIENTS To evaluate if reloading with Prasugrel compared to a high dose regimen of Clopidogrel results in more patients having a low platelet reactivity. Patients will be identified who have poor platelet response to previous Clopidogrel and have undergone an invasive procedure (PCI) to treat their narrowed or blocked heart vessels. SUBSTUDIES 1. Title: APACS-HPR genetic substudy To determine the relevant influence of genetic heritage on response variability to the Clopidogrel and Prasugrel antiplatelet treatment. 2) Title: APACS-HPR biomarker substudy To determine the variability of platelet inhibition to Clopidogrel or Prasugrel treatment if this is influenced by the inflammatory condition and the extent of platelet activation and blood flow to the heart muscle. ;Secondary Objective: (i) To compare the proportion of patients with improved platelet response between the treatment arms at hospital discharge/7 days and at 30 days. (ii) To compare the amount of damage to heart muscle using blood marker (CK, troponin) at 24 hours between the treatment arms (iii) To compare the rate of major adverse events (death, myocardial infarction, stroke, repeated revascularization) at 30 days between the treatment arms (iv) To compare the safety rate of major bleedings at 30 days between the treatment arms. ;Primary end point(s): 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	—

Measure

Time frame

Main Objective: OBSERVATIONAL REGISTRY OF SCREENED PATIENTS To identify the proportion of patients who are good responders to routine doses of Clopidogrel and compare the events of death at 30 days. RANDOMISED PATIENTS To evaluate if reloading with Prasugrel compared to a high dose regimen of Clopidogrel results in more patients having a low platelet reactivity. Patients will be identified who have poor platelet response to previous Clopidogrel and have undergone an invasive procedure (PCI) to treat their narrowed or blocked heart vessels. SUBSTUDIES 1. Title: APACS-HPR genetic substudy To determine the relevant influence of genetic heritage on response variability to the Clopidogrel and Prasugrel antiplatelet treatment. 2) Title: APACS-HPR biomarker substudy To determine the variability of platelet inhibition to Clopidogrel or Prasugrel treatment if this is influenced by the inflammatory condition and the extent of platelet activation and blood flow to the heart muscle. ;Secondary Objective: (i) To compare the proportion of patients with improved platelet response between the treatment arms at hospital discharge/7 days and at 30 days. (ii) To compare the amount of damage to heart muscle using blood marker (CK, troponin) at 24 hours between the treatment arms (iii) To compare the rate of major adverse events (death, myocardial infarction, stroke, repeated revascularization) at 30 days between the treatment arms (iv) To compare the safety rate of major bleedings at 30 days between the treatment arms. ;Primary end point(s): 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

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Countries

Germany, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026