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

August 7, 2023 updated by: Portola Pharmaceuticals

A Randomized, Double-Blind, Active-Controlled Trial to Evaluate Intravenous and Oral PRT060128, a Selective and Reversible P2Y12 Inhibitor, vs Clopidogrel, as a Novel Antiplatelet Therapy in Patients Undergoing Non-Urgent PCI

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Each patient randomized in this trial will participate for approximately 12-24 weeks, including a Screening period of up to 2 weeks, the acute peri-procedural phase, and a 60-120 day chronic treatment phase. The chronic phase includes daily in-hospital assessments until 24 Hours or Discharge (whichever comes first), a telephone follow-up on Day 7-10 post-Discharge, outpatient follow-up visits on Days 30 and 60-67, [Day 90 and Day 120 (if treated for 120 days)] and a telephone follow-up 7 days following the last dose of study drug.

Study Type

Interventional

Enrollment (Actual)

652

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Portola Investigational Site
      • Vienna, Austria
        • Portola Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Portola Investigational Site
      • Edmonton, Alberta, Canada
        • Portola Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Portola Investigational Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • Portola Investigational Site
    • Ontario
      • Newmarket, Ontario, Canada
        • Portola Investigational Site
      • Toronto, Ontario, Canada
        • Portola Investigational Site
  • Germany
      • Bad Oeynhausen, Germany
        • Portola Investigational Site
      • Bad Rothenfelde, Germany
        • Portola Investigational Site
      • Berlin, Germany
        • Portola Investigational Site
      • Bernau, Germany
        • Portola Investigational Site
      • Dachau, Germany
        • Portola Investigational Site
      • Dortmund, Germany
        • Portola Investigational Site
      • Dresden, Germany
        • Portola Investigational Site
      • Göttingen, Germany
        • Portola Investigational Site
      • Halle, Germany
        • Portola Investigational Site
      • Hannover, Germany
        • Portola Investigational Site
      • Heidelberg, Germany
        • Portola Investigational Site
      • Kassel, Germany
        • Portola Investigational Site
      • Kiel, Germany
        • Portola Investigational Site
      • Langen, Germany
        • Portola Investigational Site
      • Ludwigshafen, Germany
        • Portola Investigational Site
      • Lübeck, Germany
        • Portola Investigational Site
      • Mainz, Germany
        • Portola Investigational Site
      • Munich, Germany
        • Portola Investigational Site
      • Mönchengladbach, Germany
        • Portola Investigational Site
      • Neuss, Germany
        • Portola Investigational Site
      • Rostock, Germany
        • Portola Investigational Site
      • Schwalmstadt, Germany
        • Portola Investigational Site
      • Traunstein, Germany
        • Portola Investigational Site
      • Trier, Germany
        • Portola Investigational Site
      • Witten, Germany
        • Portola Investigational Site
      • Wuppertal, Germany
        • Portola Investigational Site
  • Poland
      • Bydgoszcz, Poland
        • Portola Investigational Site
      • Gdansk, Poland
        • Portola Investigational Site
      • Lodz, Poland
        • Portola Investigational Site
      • Lublin, Poland
        • Portola Investigational Site
      • Szczecin, Poland
        • Portola Investigational Site
      • Warsaw, Poland
        • Portola Investigational Site
  • United States
    • California
      • La Jolla, California, United States
        • Portola Investigational Site
      • Torrance, California, United States
        • Portola Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • Portola Investigational Site
    • Florida
      • Jacksonville, Florida, United States
        • Portola Investigational Site
      • Tallahassee, Florida, United States
        • Portola Investigational Site
    • Georgia
      • Augusta, Georgia, United States
        • Portola Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States
        • Portola Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States
        • Portola Investigational Site
    • Maine
      • Portland, Maine, United States
        • Portola Investigational Site
    • Maryland
      • Baltimore, Maryland, United States
        • Portola Investigational Site
    • Michigan
      • Detroit, Michigan, United States
        • Portola Investigational Site
      • Grand Blanc, Michigan, United States
        • Portola Investigational Site
    • New York
      • Brooklyn, New York, United States
        • Portola Investigational Site
    • North Carolina
      • Charleston, North Carolina, United States
        • Portola Investigational Site
      • Winston-Salem, North Carolina, United States
        • Portola Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Portola Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States
        • Portola Investigational Site
      • Lancaster, Pennsylvania, United States
        • Portola Investigational Site
    • Washington
      • Seattle, Washington, United States
        • Portola Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The patient is scheduled to undergo non-urgent PCI
  • The patient is between 18 and 75 years of age (inclusive) and willing to comply with the protocol
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours of dosing. All patients must agree to use double barrier contraception during the study and for at least 4 weeks after their last dose.
  • The patient or legally acceptable representative is able to read and give written informed consent and has signed an informed consent form approved by the Investigator's IRB/IEC

Exclusion Criteria:

  • Estimated or measured weight < 55 kg
  • Acute non-ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation myocardial infarction (STEMI) within 7 days prior to PCI
  • Chronic total occlusion or unprotected left main stenting
  • Cardiogenic shock (systolic blood pressure < 90 mm Hg requiring vasopressor or hemodynamic support)
  • Uncontrolled hypertension at the time of initial study drug administration defined as measured systolic blood pressure > 190 mm Hg or diastolic blood pressure > 108 mm Hg
  • Planned staged PCI
  • Planned surgery during the study period
  • Planned GP IIb/IIIa use
  • Patient has received a clopidogrel loading dose (≥300 mg) within 7 days prior to randomization; patients on maintenance clopidogrel may be enrolled
  • The planned administration of the study-specified clopidogrel loading dose is >12 hours prior to PCI
  • Administration of thrombolytic agents, fondaparinux, or oral anticoagulants (e.g., warfarin) within the 7 days prior to PCI
  • Estimated creatinine clearance (e.g. Cockcroft-Gault) < 45 mL/min
  • Anemia with hemoglobin level < 10 g/dL
  • Thrombocytopenia (platelet count < 100,000/mm3)
  • ALT and/or AST > 2.5 x the ULN or other indication of clinically significant hepatic dysfunction
  • Facial or head trauma within the last 30 days
  • Intraocular hemorrhage within the last 30 days
  • Gastrointestinal bleeding within the last 30 days
  • Active bleeding, or history of a bleeding disorder or known intracranial vascular malformation
  • History of any prior ischemic stroke or TIA within the last 5 years or intracranial hemorrhage, neoplasm, or arteriovenous malformation
  • Known allergy or contraindication to the components of PRT060128, aspirin, heparin, clopidogrel, glycoprotein IIb/IIIa inhibitors, or to any contrast media
  • Participation in any investigational drug study within 30 days prior to enrollment. Participation in a device trial prior to enrollment is acceptable
  • Prior participation in any study involving PRT060128
  • Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the Investigator, unacceptably increase the patient's risk by participating in the study. This would include, but is not limited to alcoholism, drug dependency or abuse, psychiatric disease, epilepsy or any unexplained blackouts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1
300mg or 600mg loading dose of Clopidogrel followed by once daily dosing of 75 mg Clopidogrel for up to 120 days.
Drug: clopidogrel
Loading dose of 300mg or 600mg, followed by once daily dosing of 75 mg
Other Names:
  • Plavix
Experimental: Arm 2
IV bolus of PRT060128 prior to PCI and twice daily administration of 50 mg oral PRT060128 for up to 120 days, with the first oral dose administered concurrently with the IV bolus.
Drug: PRT060128
80-120 mg IV bolus administered prior to PCI, followed by twice daily dosing of oral 50mg, 100mg or 150mg
Experimental: Arm 3
IV bolus of PRT060128 prior to PCI and twice daily administration of 100 mg oral PRT060128 for up to 120 days, with the first oral dose administered concurrently with the IV bolus.
Drug: PRT060128
80-120 mg IV bolus administered prior to PCI, followed by twice daily dosing of oral 50mg, 100mg or 150mg
Experimental: Arm 4
IV bolus of PRT060128 prior to PCI and twice daily administration of 150 mg oral PRT060128 for up to 120 days, with the first oral dose administered concurrently with the IV bolus.
Drug: PRT060128
80-120 mg IV bolus administered prior to PCI, followed by twice daily dosing of oral 50mg, 100mg or 150mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The study is not powered to examine a pre-specified endpoint; rather it is designed to explore a number of analyses to understand the clinical efficacy, biological activity, and tolerability and safety of PRT060128 in patients undergoing non-urgent PCI
Time Frame: 24 Hours/Discharge and Day 60
24 Hours/Discharge and Day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portola Pharmaceuticals

Investigators

  • Principal Investigator: Robert C Welsh, MD, University of Alberta
  • Study Chair: Robert Harrington, MD, Duke University
  • Principal Investigator: Sunil V Rao, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

September 10, 2008

First Submitted That Met QC Criteria

September 10, 2008

First Posted (Estimated)

September 11, 2008

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-116
  • 2008-001352-51 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Percutaneous Coronary Intervention

Clinical Trials on clopidogrel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe