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Percutaneous Coronary InterventionPhase 2INNOVATE-PCINCT00751231

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

A Phase 2 study testing clopidogrel and PRT060128 in people with Percutaneous Coronary Intervention, run by Portola Pharmaceuticals at 59 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Percutaneous Coronary Intervention
What is being tested?
clopidogrel and PRT060128
Could I receive a placebo?
No, everyone receives an active treatment
How many people
652 participants
Where
59 sitesin 5 countries
Study dates
Dec 2008to Apr 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 24Show fewer
  • 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

Trial locations and contacts

59 sites in 5 countries.

59 sites in 5 countries

Germany26 sites

  • Portola Investigational Site

    Bad Oeynhausen

  • Portola Investigational Site

    Bad Rothenfelde

  • Portola Investigational Site

    Berlin

  • Portola Investigational Site

    Bernau

  • Portola Investigational Site

    Dachau

  • Portola Investigational Site

    Dortmund

  • Portola Investigational Site

    Dresden

  • Portola Investigational Site

    Göttingen

  • Portola Investigational Site

    Halle

  • Portola Investigational Site

    Hanover

  • Portola Investigational Site

    Heidelberg

  • Portola Investigational Site

    Kassel

  • Portola Investigational Site

    Kiel

  • Portola Investigational Site

    Langen

  • Portola Investigational Site

    Lübeck

  • Portola Investigational Site

    Ludwigshafen

  • Portola Investigational Site

    Mainz

  • Portola Investigational Site

    Mönchengladbach

  • Portola Investigational Site

    Munich

  • Portola Investigational Site

    Neuss

  • Portola Investigational Site

    Rostock

  • Portola Investigational Site

    Schwalmstadt

  • Portola Investigational Site

    Traunstein

  • Portola Investigational Site

    Trier

  • Portola Investigational Site

    Witten

  • Portola Investigational Site

    Wuppertal

Other trials in Germany

United States19 sites

  • Portola Investigational Site

    Augusta, Georgia

  • Portola Investigational Site

    Baltimore, Maryland

  • Portola Investigational Site

    Brooklyn, New York

  • Portola Investigational Site

    Charleston, North Carolina

  • Portola Investigational Site

    Cincinnati, Ohio

  • Portola Investigational Site

    Detroit, Michigan

  • Portola Investigational Site

    Grand Blanc, Michigan

  • Portola Investigational Site

    Hershey, Pennsylvania

  • Portola Investigational Site

    Jacksonville, Florida

  • Portola Investigational Site

    La Jolla, California

  • Portola Investigational Site

    Lancaster, Pennsylvania

  • Portola Investigational Site

    Lexington, Kentucky

  • Portola Investigational Site

    New Orleans, Louisiana

  • Portola Investigational Site

    Portland, Maine

  • Portola Investigational Site

    Seattle, Washington

  • Portola Investigational Site

    Tallahassee, Florida

  • Portola Investigational Site

    Torrance, California

  • Portola Investigational Site

    Washington D.C., District of Columbia

  • Portola Investigational Site

    Winston-Salem, North Carolina

Other trials in United States

Canada6 sites

  • Portola Investigational Site

    Calgary, Alberta

  • Portola Investigational Site

    Edmonton, Alberta

  • Portola Investigational Site

    Newmarket, Ontario

  • Portola Investigational Site

    St. John's, Newfoundland and Labrador

  • Portola Investigational Site

    Toronto, Ontario

  • Portola Investigational Site

    Vancouver, British Columbia

Other trials in Canada

Poland6 sites

  • Portola Investigational Site

    Bydgoszcz

  • Portola Investigational Site

    Gdansk

  • Portola Investigational Site

    Lodz

  • Portola Investigational Site

    Lublin

  • Portola Investigational Site

    Szczecin

  • Portola Investigational Site

    Warsaw

Other trials in Poland

Austria2 sites

  • Portola Investigational Site

    Graz

  • Portola Investigational Site

    Vienna

Other trials in Austria

About this study

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

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.

Read the 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.

Being tested
clopidogrel, PRT060128
Keywords
PCI, percutaneous coronary intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • clopidogrelDrug

    Also called Plavix

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

  • PRT060128Drug

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

Study groups in NCT00751231
Study groupRoleWhat they receive
Arm 1Active comparator300mg or 600mg loading dose of Clopidogrel followed by once daily dosing of 75 mg Clopidogrel for up to 120 days.
Receives: Drug: clopidogrel
Arm 2ExperimentalIV 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.
Receives: Drug: PRT060128
Arm 3ExperimentalIV 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.
Receives: Drug: PRT060128
Arm 4ExperimentalIV 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.
Receives: Drug: PRT060128

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24 Hours/Discharge and Day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionApr 2010
  4. Study completionApr 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
652 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00751231
Sponsor's protocol ID
07-116
Other IDs
2008-001352-51, 2008
Acronym
INNOVATE-PCI
Status last verified
Aug 2023
First submitted
10 Sep 2008
Last updated
8 Aug 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22647518

  • 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.

    PubMed 22619259

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing clopidogrel and PRT060128 in people with Percutaneous Coronary Intervention, run by Portola Pharmaceuticals at 59 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in Germany, United States, Canada, Poland, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00751231, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.

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