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

NCT01463150 | Completed Phase 4

• 1 other identifier: PATRASCARDIOLOGY-7
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Platelet Reactivity

Keywords

Platelet reactivity; Clopidogrel; Prasugrel

Outcome Measures

Primary Outcomes (1)

• Platelet reactivity

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

  15 days

Secondary Outcomes (1)

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

  15 days

Study Arms (2)

Clopidogrel

ACTIVE COMPARATOR

Clopidogrel 150mg per day for 15 days

Drug: Clopidogrel

Prasugrel

EXPERIMENTAL

Prasugrel 5mg for 15 days

Drug: Prasugrel

Interventions

Clopidogrel DRUG

Clopidogrel 150mg per day for 15 days

Clopidogrel

Prasugrel DRUG

Prasugrel 5mg per day for 15 days

Prasugrel

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

Cardiology Department Patras University Hospital

Rio, Achaia, 26500, Greece

Location

Related Publications (1)

• 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.

  PMID: 23237136 DERIVED

MeSH Terms

Interventions

Clopidogrel; Prasugrel Hydrochloride

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: November 1, 2011
• Study Start: October 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 11, 2012

Record last verified: 2012-04

Locations

GR (1)