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Antiplatelet Agent

Loading Dose Arm for Coronary Artery Disease (PPD Trial)

N/A
Waitlist Available
Led By Richard A Shlofmitz, MD
Research Sponsored by St. Francis Hospital, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours post pci or at time of discharge and 30 days post pci
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

* The purpose of this study is to determine the level of inhibition of platelet activation of an approved thienopyridine(clopidogrel or prasugrel) and aspirin regimen in the setting of drug eluting coronary stent implantation. * In subjects with high residual levels of platelet reactivity after receiving either a maintenance or loading dose of either clopidogrel or prasugrel, a cross over of thienopyridine treatment to the alternate medication will occur. * The study tests the hypothesis that adequate platelet inhibition will occur in subjects who have high levels of platelet reactivity and are subsequently switched from clopidogrel to prasugrel(loading or maintenance dose) without increased episodes of bleeding or MACE events at discharge and 30 days post Percutaneous Coronary Intervention (PCI).

Eligible Conditions
  • Coronary Artery Disease
  • Platelet Aggregation Inhibitors
  • Percutaneous Coronary Intervention

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours post pci or at time of discharge and 30 days post pci
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours post pci or at time of discharge and 30 days post pci for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in platelet reactivity after switching medication regimen of two thienopyridines- clopidogrel and prasugrel
Secondary study objectives
Occurrence of all MACE events for subjects enrolled into the trial
Occurrence of all bleeding events for subjects enrolled into the trial

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Loading Dose ArmActive Control1 Intervention
Clopidogrel 600 mg or Prasugrel 60 mg at time of PCI.
Group II: Maintenance Dose ArmActive Control1 Intervention
Open label clopidogrel 75 mg daily or prasugrel 10 mg daily

Find a Location

Who is running the clinical trial?

St. Francis Hospital, New YorkLead Sponsor
8 Previous Clinical Trials
1,315 Total Patients Enrolled
3 Trials studying Coronary Artery Disease
254 Patients Enrolled for Coronary Artery Disease
Richard A Shlofmitz, MDPrincipal InvestigatorSaint Francis Hospital
2 Previous Clinical Trials
250 Total Patients Enrolled
2 Trials studying Coronary Artery Disease
250 Patients Enrolled for Coronary Artery Disease
~64 spots leftby Nov 2025