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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01463150

Enrollment

Registered

2011-11-01

Start date

2011-10-31

Completion date

2012-07-31

Last updated

2012-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Platelet Reactivity

Keywords

Platelet reactivity, Clopidogrel, Prasugrel

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.

Interventions

DRUGClopidogrel

Clopidogrel 150mg per day for 15 days

DRUGPrasugrel

Prasugrel 5mg per day for 15 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026