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OpenTrials
Completed

NCT Number: NCT01463150

Prasugrel 5mg Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Aged ≥75 Years and/or Weighing <60 kg Post Percutaneous Coronary Intervention (PCI)

The use of dual antiplatelet therapy is considered standard of care in patients post percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of patients is considered clopidogrel resistant and this resistance is shown to be accompanied by future adverse events. The aim of the study is to define in consecutive patients with acute coronary syndrome (ACS) undergoing PCI, those aged>75years and/or weighted<60 Kg with high on-clopidogrel platelet reactivity (Platelet Reactivity Units-PRU≥235) as estimated 24 hours post PCI with the VerifyNow assay. Those patients will be randomized after informed concent in 1:1 fashion to prasugrel 5 mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at day 15 and then treatment crossover will be performed. At day 30 platelet reactivity will be determined as well.

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Key information

Conditions

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cardiology Department Patras University Hospital

Rio, Achaia, 26500, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years old
  • Patients having PCI with stenting 24 hours prior randomization, meeting the following criteria :
  • Acute coronary syndrome (unstable angina or myocardial infarction)
  • TIMI risk score>2
  • Platelet reactivity in PRU ≥235 24 hours post-PCI
  • Age≥75 years and/or weight<60 Kg
  • Informed consent obtained in writing

Exclusion criteria

  • A history of bleeding diathesis
  • Chronic oral anticoagulation treatment
  • Contraindications to antiplatelet therapy
  • Known platelet function disorders
  • PCI or coronary artery bypass surgery < 3 months
  • Unsuccessful PCI (residual stenosis > 30% or flow < Thrombolysis in myocardial infarction flow 3)
  • Planned staged PCI in the next 30 days
  • Hemodynamic instability
  • hemodialysis
  • Creatinine clearance <25 ml/min
  • inability to give informed consent
  • High likelihood of being unavailable for the Day 30
  • History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
  • Other bleeding diathesis, or considered by investigator to be at high risk for bleeding on longterm antiplatelet therapy.
  • Any previous history of ischemic stroke, transient ischemic attack, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
  • Thrombocytopenia (<100.000 / μL) at randomization
  • Anaemia (Hct <30%) at randomization
  • Polycythaemia (Hct > 52%) at randomization
  • Periprocedural IIb/IIIa inhibitor administration

Treatment and study plan

clopidogrel

Drug

Clopidogrel 150mg per day for 15 days

Prasugrel

Drug

Prasugrel 5mg per day for 15 days

Primary outcomes

  1. Platelet reactivity

    Time frame: 15 days

    Platelet reactivity assessed with the VerifyNow assay at the end of each treatment period

Secondary outcomes

  1. Hyporesponsiveness rate (PRU≥235) at the end of the 2 treatment periods

    Time frame: 15 days

    Hyporesponsiveness rate will be assessed 15 days after the onset of each study drug

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 1, 2011
Registry last updated
Jul 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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