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.

Study Overview

• Status: Completed
• Conditions: Platelet Reactivity
• Intervention / Treatment: Drug: Clopidogrel; Drug: Prasugrel

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 4

Contacts and Locations

Study Locations

• Greece
  • Achaia
    • Rio, Achaia, Greece, 26500
      • Cardiology Department Patras University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥18 years old

2. 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
3. Platelet reactivity in PRU ≥235 24 hours post-PCI
4. Age≥75 years and/or weight<60 Kg

4. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clopidogrel; Clopidogrel 150mg per day for 15 days	Drug: Clopidogrel; Clopidogrel 150mg per day for 15 days
Experimental: Prasugrel; Prasugrel 5mg for 15 days	Drug: Prasugrel; Prasugrel 5mg per day for 15 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet reactivity	Platelet reactivity assessed with the VerifyNow assay at the end of each treatment period	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hyporesponsiveness rate (PRU≥235) at the end of the 2 treatment periods	Hyporesponsiveness rate will be assessed 15 days after the onset of each study drug	15 days

Collaborators and Investigators

• Sponsor: University of Patras

Publications and helpful links

General Publications

• Alexopoulos D, Xanthopoulou I, Plakomyti TE, Theodoropoulos KC, Mavronasiou E, Damelou A, Hahalis G, Davlouros P. Pharmacodynamic effect of prasugrel 5 mg vs clopidogrel 150 mg in elderly patients with high on-clopidogrel platelet reactivity. Am Heart J. 2013 Jan;165(1):73-9. doi: 10.1016/j.ahj.2012.10.008. Epub 2012 Nov 14.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: October 27, 2011
• First Submitted That Met QC Criteria: October 31, 2011
• First Posted (Estimate): November 1, 2011

Study Record Updates

• Last Update Posted (Estimate): July 11, 2012
• Last Update Submitted That Met QC Criteria: July 10, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Prasugrel; Clopidogrel; Platelet reactivity
• Additional Relevant MeSH Terms: Body Weight; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel; Prasugrel Hydrochloride
• Other Study ID Numbers: PATRASCARDIOLOGY-7