Overview

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

Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Patras
Treatments:
Clopidogrel
Prasugrel Hydrochloride
Ticlopidine
Criteria
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