Aggrastat Truncated Length Against Standard Therapies in Percutaneous Coronary Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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Detailed Description

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Conditions

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Myocardial Infarction Acute Coronary Syndromes Unstable Angina Percutaneous Coronary Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tirofiban (Aggrastat)

Group Type EXPERIMENTAL

Tirofiban (Aggrastat)

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No