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Aggrastat Truncated Length Against Standard Therapies in Percutaneous Coronary Intervention (ATLAST-PCI)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Myocardial Infarction Acute Coronary Syndromes Unstable Angina Percutaneous Coronary Intervention | Drug: Tirofiban (Aggrastat) Drug: Placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- A composite incidence of death, myocardial infarction and urgent target vessel revascularization. [ Time Frame: 48 hours ]
- The occurrence of myocardial infarction. [ Time Frame: 48 hours ]
| Estimated Enrollment: | 1900 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Tirofiban (Aggrastat) |
Drug: Tirofiban (Aggrastat)
Tirofiban (Aggrastat) will be dosed as a 25mcg/kg i.v. bolus followed by a 0.15mcg/kg/min i.v. infusion during a percutaneous coronary intervention plus two hours after the procedure. Patients will receive tirofiban (Aggrastat) on a background of oral anti-platelet agent(s) and either unfractionated heparin (50U/kg and repeat dosing guided per guidelines) or bivalirudin as per local practice and physician discretion. |
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo will be dosed as an i.v. bolus followed by an i.v. infusion during a percutaneous coronary intervention plus two hours after the procedure. Patients will receive placebo on a background of oral anti-platelet agent(s) and either unfractionated heparin (50U/kg and repeat dosing guided per guidelines) or bivalirudin as per local practice and physician discretion. |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age >18 years of age
- Scheduled to undergo PCI with an approved device
- Written informed consent
Exclusion Criteria:
- Primary PCI for ST-elevation myocardial infarction (STEMI)
- Prior PCI within 30 days
- Prior GPIIb/IIIa use within 14 days
- Prior enoxaparin use within 4 days
- Prior STEMI within 30 days
- 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01245725
| Principal Investigator: | Steven V Manoukian, MD | SCRI Development Innovations, LLC |
More Information
Publications:
| Responsible Party: | Medicure |
| ClinicalTrials.gov Identifier: | NCT01245725 History of Changes |
| Other Study ID Numbers: |
10002 |
| Study First Received: | November 12, 2010 |
| Last Updated: | April 7, 2015 |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Acute Coronary Syndrome Angina, Unstable Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
Angina Pectoris Chest Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Tirofiban Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors |
ClinicalTrials.gov processed this record on June 23, 2017