Aggrastat Truncated Length Against Standard Therapies in Percutaneous Coronary Intervention
Information source: Medicure
ClinicalTrials.gov processed this data on August 20, 2015 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: Suspended
Sponsored by: Medicure Official(s) and/or principal investigator(s): Steven V Manoukian, MD, Principal Investigator, Affiliation: SCRI Development Innovations, LLC
Summary
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.
Clinical Details
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age >18 years of age
2. Scheduled to undergo PCI with an approved device
3. Written informed consent
Exclusion Criteria:
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
laboratory.
Locations and Contacts
Additional Information
Related publications: Topol EJ, Moliterno DJ, Herrmann HC, Powers ER, Grines CL, Cohen DJ, Cohen EA, Bertrand M, Neumann FJ, Stone GW, DiBattiste PM, Demopoulos L; TARGET Investigators. Do Tirofiban and ReoPro Give Similar Efficacy Trial. Comparison of two platelet glycoprotein IIb/IIIa inhibitors, tirofiban and abciximab, for the prevention of ischemic events with percutaneous coronary revascularization. N Engl J Med. 2001 Jun 21;344(25):1888-94. Valgimigli M, Percoco G, Barbieri D, Ferrari F, Guardigli G, Parrinello G, Soukhomovskaia O, Ferrari R. The additive value of tirofiban administered with the high-dose bolus in the prevention of ischemic complications during high-risk coronary angioplasty: the ADVANCE Trial. J Am Coll Cardiol. 2004 Jul 7;44(1):14-9. Valgimigli M, Campo G, de Cesare N, Meliga E, Vranckx P, Furgieri A, Angiolillo DJ, Sabatè M, Hamon M, Repetto A, Colangelo S, Brugaletta S, Parrinello G, Percoco G, Ferrari R; Tailoring Treatment With Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel (3T/2R) Investigators. Intensifying platelet inhibition with tirofiban in poor responders to aspirin, clopidogrel, or both agents undergoing elective coronary intervention: results from the double-blind, prospective, randomized Tailoring Treatment with Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel study. Circulation. 2009 Jun 30;119(25):3215-22. doi: 10.1161/CIRCULATIONAHA.108.833236. Epub 2009 Jun 15. Valgimigli M, Campo G, Percoco G, Bolognese L, Vassanelli C, Colangelo S, de Cesare N, Rodriguez AE, Ferrario M, Moreno R, Piva T, Sheiban I, Pasquetto G, Prati F, Nazzaro MS, Parrinello G, Ferrari R; Multicentre Evaluation of Single High-Dose Bolus Tirofiban vs Abciximab With Sirolimus-Eluting Stent or Bare Metal Stent in Acute Myocardial Infarction Study (MULTISTRATEGY) Investigators. Comparison of angioplasty with infusion of tirofiban or abciximab and with implantation of sirolimus-eluting or uncoated stents for acute myocardial infarction: the MULTISTRATEGY randomized trial. JAMA. 2008 Apr 16;299(15):1788-99. doi: 10.1001/jama.299.15.joc80026. Epub 2008 Mar 30. Valgimigli M, Tebaldi M. Safety evaluation of tirofiban. Expert Opin Drug Saf. 2010 Sep;9(5):801-19. doi: 10.1517/14740338.2010.507189. Review. Moliterno DJ; TENACITY Steering Committee and Investigators. A randomized two-by-two comparison of high-dose bolus tirofiban versus abciximab and unfractionated heparin versus bivalirudin during percutaneous coronary revascularization and stent placement: the tirofiban evaluation of novel dosing versus abciximab with clopidogrel and inhibition of thrombin (TENACITY) study trial. Catheter Cardiovasc Interv. 2011 Jun 1;77(7):1001-9. doi: 10.1002/ccd.22876. Epub 2011 Jan 11.
Last updated: April 7, 2015
|