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

Sponsor

University of Patras (Other)

Overall Status

Completed

CT.gov ID

NCT01463150

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Platelet Reactivity	Drug: Clopidogrel Drug: Prasugrel	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Platelet reactivity [15 days]
Platelet reactivity assessed with the VerifyNow assay at the end of each treatment period

Secondary Outcome Measures

Hyporesponsiveness rate (PRU≥235) at the end of the 2 treatment periods [15 days]
Hyporesponsiveness rate will be assessed 15 days after the onset of each study drug

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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