Aggrastat Truncated Length Against Standard Therapies in Percutaneous Coronary Intervention
Information source: Medicure
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myocardial Infarction; Acute Coronary Syndromes; Unstable Angina; Percutaneous Coronary Intervention
Intervention: Tirofiban (Aggrastat) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Medicure
Official(s) and/or principal investigator(s):
Steven V Manoukian, MD, Principal Investigator, Affiliation: Sarah Cannon Research Institute
Michael Janzen, PhD, Phone: 204-488-1886, Ext: *355
The purpose of this study is to determine whether the efficacy of tirofiban (a 25mcg/kg i. v.
bolus followed by a 0. 15mcg/kg/min i. v. infusion during a percutaneous coronary intervention
(PCI) plus two hours after the procedure) is more effective than placebo in the setting of
standard therapies (e. g. aspirin, a thienopyridine, and unfractionated heparin or
bivalirudin) among patients undergoing PCI, as assessed by the incidence of adverse cardiac
ischemic events defined as death, myocardial infarction (MI), and urgent target vessel
revascularization (uTVR) within 48 hours following study drug initiation.
A secondary objective of this study is to assess whether tirofiban (a 25mcg/kg i. v. bolus
followed by a 0. 15mcg/kg/min i. v. infusion during a PCI plus two hours after the procedure)
is safe compared to placebo in the setting of standard therapies (e. g. aspirin, a
thienopyridine, and unfractionated heparin or bivalirudin) among patients undergoing PCI, as
assessed by the incidence of non-CABG-related TIMI major bleeding within 48 hours following
study drug initiation.
Patient enrollment is pending.
Official title: A Randomized, Multicenter, Double-Blind, Study to Evaluate the Efficacy of Tirofiban HCl Versus Placebo in the Setting of Standard Therapies Among Subjects Undergoing Percutaneous Coronary Intervention
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: A composite incidence of death, myocardial infarction and urgent target vessel revascularization.
Secondary outcome: The occurrence of myocardial infarction.
Minimum age: 18 Years.
Maximum age: N/A.
1. Age >18 years of age
2. Scheduled to undergo PCI with an approved device
3. Written informed consent
1. Primary PCI for ST-elevation myocardial infarction (STEMI)
2. Prior PCI within 30 days
3. Prior GPIIb/IIIa use within 14 days
4. Prior enoxaparin use within 4 days
5. Prior STEMI within 30 days
6. In non-elective subjects, a rising troponin defined as a most recent pre-PCI sample
greater than the sample immediately preceding it, as long as the two samples are
separated by four or more hours and have been analyzed in the same hospital
Locations and Contacts
Michael Janzen, PhD, Phone: 204-488-1886, Ext: *355Additional Information
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Starting date: December 2012
Last updated: September 26, 2011