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A Phase 2 Safety and Efficacy Study of PRT060128, a Novel Intravenous and Oral P2Y12 Inhibitor, in Non-Urgent PCI

NCT00751231 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 652

Last updated 2023-08-08

No results posted yet for this study

Summary

This is a multi-center, randomized, double-blind, triple-dummy, clopidogrel-controlled study of IV and oral PRT060128 compared to clopidogrel in patients undergoing non-urgent (including elective) PCI. After diagnostic angiography, patients scheduled for non-urgent PCI will be randomized to clopidogrel or to one of three dose levels of PRT060128.

Conditions

  • Percutaneous Coronary Intervention

Interventions

DRUG

clopidogrel

Loading dose of 300mg or 600mg, followed by once daily dosing of 75 mg

DRUG

PRT060128

80-120 mg IV bolus administered prior to PCI, followed by twice daily dosing of oral 50mg, 100mg or 150mg

Sponsors & Collaborators

  • Portola Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Robert Harrington, MD · Duke University

  • Sunil V Rao, MD · Duke University

  • Robert C Welsh, MD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States
  • Austria
  • Canada
  • Germany
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00751231 on ClinicalTrials.gov