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

Percutaneous Coronary Intervention Clinical Trial

— INNOVATE-PCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00751231
• Other study ID #: 07-116
• Secondary ID: 2008-001352-51
• Status: Completed
• Phase: Phase 2
• Start date: December 2008
• Est. completion date: April 2010

Study information

• Verified date: August 2023
• Source: Alexion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 652
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Percutaneous Coronary Intervention

Intervention

Drug:
• clopidogrel
Loading dose of 300mg or 600mg, followed by once daily dosing of 75 mg
• PRT060128
80-120 mg IV bolus administered prior to PCI, followed by twice daily dosing of oral 50mg, 100mg or 150mg

Locations

Country	Name	City	State
Austria	Portola Investigational Site	Graz
Austria	Portola Investigational Site	Vienna
Canada	Portola Investigational Site	Calgary	Alberta
Canada	Portola Investigational Site	Edmonton	Alberta
Canada	Portola Investigational Site	Newmarket	Ontario
Canada	Portola Investigational Site	St. John's	Newfoundland and Labrador
Canada	Portola Investigational Site	Toronto	Ontario
Canada	Portola Investigational Site	Vancouver	British Columbia
Germany	Portola Investigational Site	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	Lübeck
Germany	Portola Investigational Site	Ludwigshafen
Germany	Portola Investigational Site	Mainz
Germany	Portola Investigational Site	Mönchengladbach
Germany	Portola Investigational Site	Munich
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
Poland	Portola Investigational Site	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
United States	Portola Investigational Site	Augusta	Georgia
United States	Portola Investigational Site	Baltimore	Maryland
United States	Portola Investigational Site	Brooklyn	New York
United States	Portola Investigational Site	Charleston	North Carolina
United States	Portola Investigational Site	Cincinnati	Ohio
United States	Portola Investigational Site	Detroit	Michigan
United States	Portola Investigational Site	Grand Blanc	Michigan
United States	Portola Investigational Site	Hershey	Pennsylvania
United States	Portola Investigational Site	Jacksonville	Florida
United States	Portola Investigational Site	La Jolla	California
United States	Portola Investigational Site	Lancaster	Pennsylvania
United States	Portola Investigational Site	Lexington	Kentucky
United States	Portola Investigational Site	New Orleans	Louisiana
United States	Portola Investigational Site	Portland	Maine
United States	Portola Investigational Site	Seattle	Washington
United States	Portola Investigational Site	Tallahassee	Florida
United States	Portola Investigational Site	Torrance	California
United States	Portola Investigational Site	Washington	District of Columbia
United States	Portola Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Portola Pharmaceuticals

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		24 Hours/Discharge and Day 60

External Links

•   A Randomized, Double-Blind, Active-Controlled Phase 2 Trial to Evaluate a Novel Selective and Reversible Intravenous and Oral P2Y12 Inhibitor Elinogrel Versus Clopidogrel in Patients Undergoing Nonurgent PCI: The INNOVATE-PCI Trial
•   Pharmacokinetic and Pharmacodynamic Effects of Elinogrel: Results of the Platelet Function Substudy From the Intravenous and Oral Administration of Elinogrel to Evaluate Tolerability and Efficacy in Nonurgent PCI Patients (INNOVATE-PCI) Trial