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

Platelet Reactivity Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463150
• Other study ID #: PATRASCARDIOLOGY-7
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2011
• Last updated: July 10, 2012
• Start date: October 2011
• Est. completion date: July 2012

Study information

• Verified date: April 2012
• Source: University of Patras
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Platelet Reactivity

Intervention

Drug:
• Clopidogrel
Clopidogrel 150mg per day for 15 days
• Prasugrel
Prasugrel 5mg per day for 15 days

Locations

Country	Name	City	State
Greece	Cardiology Department Patras University Hospital	Rio	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet reactivity	Platelet reactivity assessed with the VerifyNow assay at the end of each treatment period	15 days	No
Secondary	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	No