Aggrastat Truncated Length Against Standard Therapies in Percutaneous Coronary Intervention (ATLAST-PCI)

March 9, 2018 updated by: Medicure

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A composite incidence of death, myocardial infarction and urgent target vessel revascularization.
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
The occurrence of myocardial infarction.
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medicure

Collaborators

SCRI Development Innovations, LLC

Investigators

  • Principal Investigator: Steven V Manoukian, MD, SCRI Development Innovations, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 12, 2010

First Submitted That Met QC Criteria

November 19, 2010

First Posted (Estimate)

November 22, 2010

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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