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

NCT00751231 | Completed Phase 2 DMC

• 2 other identifiers: 07-1162008-001352-51
• Study Type: interventional
• Target: 652
• Locations: 5 countries
• Sites: 59

Brief 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

Keywords

PCI; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Arm 1

ACTIVE COMPARATOR

300mg or 600mg loading dose of Clopidogrel followed by once daily dosing of 75 mg Clopidogrel for up to 120 days.

Drug: clopidogrel

Arm 2

EXPERIMENTAL

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

Arm 3

EXPERIMENTAL

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

Arm 4

EXPERIMENTAL

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

Interventions

clopidogrel DRUG

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

Also known as: Plavix

Arm 1

PRT060128 DRUG

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

Arm 2; Arm 3; Arm 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Portola Pharmaceuticals: lead

Study Sites (59)

Portola Investigational Site

La Jolla, California, United States

Location

Portola Investigational Site

Torrance, California, United States

Location

Portola Investigational Site

Washington D.C., District of Columbia, United States

Location

Portola Investigational Site

Jacksonville, Florida, United States

Location

Portola Investigational Site

Tallahassee, Florida, United States

Location

Portola Investigational Site

Augusta, Georgia, United States

Location

Portola Investigational Site

Lexington, Kentucky, United States

Location

Portola Investigational Site

New Orleans, Louisiana, United States

Location

Portola Investigational Site

Portland, Maine, United States

Location

Portola Investigational Site

Baltimore, Maryland, United States

Location

Portola Investigational Site

Detroit, Michigan, United States

Location

Portola Investigational Site

Grand Blanc, Michigan, United States

Location

Portola Investigational Site

Brooklyn, New York, United States

Location

Portola Investigational Site

Charleston, North Carolina, United States

Location

Portola Investigational Site

Winston-Salem, North Carolina, United States

Location

Portola Investigational Site

Cincinnati, Ohio, United States

Location

Portola Investigational Site

Hershey, Pennsylvania, United States

Location

Portola Investigational Site

Lancaster, Pennsylvania, United States

Location

Portola Investigational Site

Seattle, Washington, United States

Location

Portola Investigational Site

Graz, Austria

Location

Portola Investigational Site

Vienna, Austria

Location

Portola Investigational Site

Calgary, Alberta, Canada

Location

Portola Investigational Site

Edmonton, Alberta, Canada

Location

Portola Investigational Site

Vancouver, British Columbia, Canada

Location

Portola Investigational Site

St. John's, Newfoundland and Labrador, Canada

Location

Portola Investigational Site

Newmarket, Ontario, Canada

Location

Portola Investigational Site

Toronto, Ontario, Canada

Location

Portola Investigational Site

Bad Oeynhausen, Germany

Location

Portola Investigational Site

Bad Rothenfelde, Germany

Location

Portola Investigational Site

Berlin, Germany

Location

Portola Investigational Site

Bernau, Germany

Location

Portola Investigational Site

Dachau, Germany

Location

Portola Investigational Site

Dortmund, Germany

Location

Portola Investigational Site

Dresden, Germany

Location

Portola Investigational Site

Göttingen, Germany

Location

Portola Investigational Site

Halle, Germany

Location

Portola Investigational Site

Hanover, Germany

Location

Portola Investigational Site

Heidelberg, Germany

Location

Portola Investigational Site

Kassel, Germany

Location

Portola Investigational Site

Kiel, Germany

Location

Portola Investigational Site

Langen, Germany

Location

Portola Investigational Site

Ludwigshafen, Germany

Location

Portola Investigational Site

Lübeck, Germany

Location

Portola Investigational Site

Mainz, Germany

Location

Portola Investigational Site

Mönchengladbach, Germany

Location

Portola Investigational Site

Munich, Germany

Location

Portola Investigational Site

Neuss, Germany

Location

Portola Investigational Site

Rostock, Germany

Location

Portola Investigational Site

Schwalmstadt, Germany

Location

Portola Investigational Site

Traunstein, Germany

Location

Portola Investigational Site

Trier, Germany

Location

Portola Investigational Site

Witten, Germany

Location

Portola Investigational Site

Wuppertal, Germany

Location

Portola Investigational Site

Bydgoszcz, Poland

Location

Portola Investigational Site

Gdansk, Poland

Location

Portola Investigational Site

Lodz, Poland

Location

Portola Investigational Site

Lublin, Poland

Location

Portola Investigational Site

Szczecin, Poland

Location

Portola Investigational Site

Warsaw, Poland

Location

Related Publications (2)

• Welsh RC, Rao SV, Zeymer U, Thompson VP, Huber K, Kochman J, McClure MW, Gretler DD, Bhatt DL, Gibson CM, Angiolillo DJ, Gurbel PA, Berdan LG, Paynter G, Leonardi S, Madan M, French WJ, Harrington RA; INNOVATE-PCI Investigators. 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 percutaneous coronary intervention: the INNOVATE-PCI trial. Circ Cardiovasc Interv. 2012 Jun;5(3):336-46. doi: 10.1161/CIRCINTERVENTIONS.111.964197. Epub 2012 May 29.

  PMID: 22647518 DERIVED

• Angiolillo DJ, Welsh RC, Trenk D, Neumann FJ, Conley PB, McClure MW, Stephens G, Kochman J, Jennings LK, Gurbel PA, Wojcik J, Dabrowski M, Saucedo JF, Stumpf J, Buerke M, Broderick S, Harrington RA, Rao SV. 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 percutaneous coronary intervention patients (INNOVATE-PCI) trial. Circ Cardiovasc Interv. 2012 Jun;5(3):347-56. doi: 10.1161/CIRCINTERVENTIONS.111.965608. Epub 2012 May 22.

  PMID: 22619259 DERIVED

Related 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

MeSH Terms

Interventions

Clopidogrel; elinogrel

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Robert Harrington, MD

  Duke University

  STUDY CHAIR

• Sunil V Rao, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Robert C Welsh, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2008
• First Posted: September 11, 2008
• Study Start: December 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: August 8, 2023

Record last verified: 2023-08

Locations

AU (2); CA (6); PL (6); DE (26); US (19)