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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001352-51 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clopidogrel | Drug | Loading dose of 300mg or 600mg, followed by once daily dosing of 75 mg |
|
| Measure | Description | 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 | 24 Hours/Discharge and Day 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Harrington, MD | Duke University | Study Chair |
| Sunil V Rao, MD | Duke University | Principal Investigator |
| Robert C Welsh, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Portola Investigational Site | La Jolla | California | United States | |||
| Portola Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22647518 | Derived | 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. | |
| 22619259 |
| Label | URL |
|---|---|
| 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 | View source |
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| PRT060128 | Drug | 80-120 mg IV bolus administered prior to PCI, followed by twice daily dosing of oral 50mg, 100mg or 150mg |
|
| Torrance |
| California |
| United States |
| Portola Investigational Site | Washington D.C. | District of Columbia | United States |
| Portola Investigational Site | Jacksonville | Florida | United States |
| Portola Investigational Site | Tallahassee | Florida | United States |
| Portola Investigational Site | Augusta | Georgia | 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 | Baltimore | Maryland | United States |
| Portola Investigational Site | Detroit | Michigan | United States |
| Portola Investigational Site | Grand Blanc | Michigan | United States |
| Portola Investigational Site | Brooklyn | New York | United States |
| Portola Investigational Site | Charleston | North Carolina | United States |
| Portola Investigational Site | Winston-Salem | North Carolina | United States |
| Portola Investigational Site | Cincinnati | Ohio | United States |
| Portola Investigational Site | Hershey | Pennsylvania | United States |
| Portola Investigational Site | Lancaster | Pennsylvania | United States |
| Portola Investigational Site | Seattle | Washington | United States |
| Portola Investigational Site | Graz | Austria |
| Portola Investigational Site | Vienna | Austria |
| Portola Investigational Site | Calgary | Alberta | Canada |
| Portola Investigational Site | Edmonton | Alberta | Canada |
| Portola Investigational Site | Vancouver | British Columbia | Canada |
| Portola Investigational Site | St. John's | Newfoundland and Labrador | Canada |
| Portola Investigational Site | Newmarket | Ontario | Canada |
| Portola Investigational Site | Toronto | Ontario | Canada |
| 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 | Hanover | 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 | 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 | Germany |
| 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 | Poland |
| 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. |
| 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 | View source |
| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| C549473 | elinogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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