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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
- The occurrence of myocardial infarction. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
| 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 |
| Genders Eligible for Study: | Both |
| 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 Locations 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: | January 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Angina, Unstable Infarction Myocardial Infarction Acute Coronary Syndrome Angina Pectoris Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Chest Pain Pain Signs and Symptoms |
Ischemia Pathologic Processes Necrosis Tirofiban Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Hematologic Agents Platelet Aggregation Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013