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Evaluating Additional Platelet Inhibition in Patients With High Platelet Reactivity Undergoing Percutaneous Coronary Intervention (APACS-HPR)

This study is currently recruiting participants.
Verified May 2012 by Royal Brompton & Harefield NHS Foundation Trust
Sponsor:
Collaborator:
University Hospital Tuebingen
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01339026
First received: April 19, 2011
Last updated: May 3, 2012
Last verified: May 2012
History of Changes
  Purpose

Patients admitted to hospital with chest pain due to reduced blood flow to heart muscle (diagnosis Acute Coronary Syndrome) can be treated with medication and an angioplasty ± stent procedure, which restores blood flow to the heart. Antiplatelet drugs (Aspirin and Clopidogrel) are blood thinning treatments and research has reported they reduce heart attacks, death and stroke. The investigators know some patients do not respond fully to Clopidogrel but currently patients are not tested for this.

The investigators wish to perform a trial to identify those patients who do not respond fully to Clopidogrel and randomise them to either Prasugrel (newer drug) or a higher dose of Clopidogrel.

Patients admitted to the hospitals (2 in the UK and 1 in Germany) will be asked for their consent to participate. A blood sample is tested for platelet activity.

  1. Low platelet activity result means patient has responded well to Clopidogrel and will continue on the routine dose. They will be entered into an observational registry. Data will be collected of routine blood tests and investigations, medication and procedures. Their GP will be contacted at about 30 days to see if they are alive.
  2. High platelet activity results means patient has not responded fully to Clopidogrel. These patients will be randomly allocated to a higher dose of Clopidogrel or new drug Prasugrel. Data will be collected of routine blood tests and investigations, medication and procedures. A hospital visit at 30±5 days is required to assess how patients are doing, medications and occurrence of any events.

Condition Intervention Phase
Cardiovascular Disease
Acute Coronary Syndrome
 Drug: Prasugrel
Drug: Plavix
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluating the Benefit of Additional Platelet Inhibition in Acute Coronary Syndrome Patients With High Platelet Reactivity Undergoing PCI

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • Platelet Reactivity [ Time Frame: 4 hours post loading dose ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Platelet reactivity in response to randomised study drug [ Time Frame: 7 days/hospital discharge and 30 days ] [ Designated as safety issue: No ]
    To compare the proportion of patients with improved platelet response between the treatment arms at hospital discharge/7 days and at 30 days.

  • Extent of myocardial damage [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    To compare the AUC for CK and troponin at 24 hours between the treatment arms

  • MACE [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    To compare the rates major adverse events (death, myocardial infarction, stroke, repeated revascularization) at 30 days between the treatment arms

  • Bleed [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    To compare the rate of major bleedings at 30 days between the treatment arms


Estimated Enrollment: 140
Study Start Date: February 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prasugrel
Day 1 loading 60mg Day 2 to 7 10mg o.d. Day 8 to 30 days 10mg od
 Drug: Prasugrel
Day 1 loading 60mg Day 2 to 7 10mg o.d. Day 8 to 30 days 10mg od
Other Name: Efient
Active Comparator: Clopidogrel
Day 1 Loading 600mg Day 2 to 7 day: 150mg o.d. Day 8 to 30 days: 75mg o.d.
 Drug: Plavix
Clopidogrel (Plavix) Day 1 Loading 600mg Day 2 to 7 day: 150mg o.d. Day 8 to 30 days: 75mg o.d.
Other Name: Clopidogrel

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ACS patients with intent for PCI <72 hours from admission.
  2. Prior clopidogrel loading within 24h before planned PCI or chronic (>24 hours) treatment with clopidogrel
  3. High platelet reactivity (HPR) PA > 400 AU min by multiplate analyser ("poor responders")
  4. Initial platelet function sample at least 2 hours after pre PCI loading dose
  5. Consent

Exclusion Criteria:

  1. Patients <18 years and >75 years
  2. Body weight <60kg
  3. Pretreatment with prasugrel within 7 days of randomisation
  4. History of stroke or transient ischaemic attack

  5. 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
  6. Hb<10g/dL
  7. Intracranial neoplasm, arteriovenous malformation or aneurysm.
  8. Severe hepatic impairment (Child Pugh class C)

  9. 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
  10. Female patients who are pregnant, planning pregnancy, not using reliable contraception or who are breastfeeding
  11. Known allergy, hypersensitivity or other contraindications to prasugrel or clopidogrel
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01339026

Contacts
Contact: Jean Booth, BSc MSc +44 2073518827 j.booth@rbht.nhs.uk
Contact: Daphne Babalis, MSc +44 207351 8827 d.babalis@rbht.nhs.uk

Locations
Germany
Universitätsklinikum Tübingen Recruiting
Tübingen, Germany
Contact: Tobias Geisler, MD            
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
University Hospital Tuebingen
Investigators
Principal Investigator: Miles Dalby, MD Royal Brompton & Harefield NHS Foundation Trust
Principal Investigator: Tobias Geisler, MD University Hospital Tuebingen
Principal Investigator: Azfar Zaman, MD Freeman Hospital and University of Newcastle
  More Information

No publications provided

Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01339026     History of Changes
Other Study ID Numbers: 2010-020219-35
Study First Received: April 19, 2011
Last Updated: May 3, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Acute coronary syndrome
Platelet reactivity
Clopidogrel
Percutaneous coronary intervention

Additional relevant MeSH terms:
Cardiovascular Diseases
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
Prasugrel
 Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013