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OpenTrials
Completed

NCT Number: NCT01522417

Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention

The purpose this study is to assess whether a tirofiban regimen of a high-dose bolus plus a shortened infusion duration compared to label-dosing eptifibatide in patients undergoing percutaneous coronary intervention (PCI) is associated with a non-inferior composite rate of death, PCI-related myocardial infarction, urgent target vessel revascularization or in-hospital major bleeding within 48 hours following PCI or hospital discharge, whichever comes first.

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Key information

Conditions

Myocardial Infarction Acute Coronary Syndrome Acute Coronary Syndromes Angina Pectoris Angina, Unstable Cardiovascular Diseases Chest Pain Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Unstable Angina Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Osceola Regional Medical Center, Kissimmee, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years of age
  • Scheduled to undergo PCI with an FDA, approved or cleared device (stent or procedures such as balloon angioplasty, rotoblation, AngioSculpt, laser atherectomy,etc.) in one or more native coronary target lesions
  • Written informed consent

Exclusion criteria

  • Primary PCI for STEMI as index procedure
  • Prior STEMI within 48 hours before randomization
  • Prior PCI within 30 days before randomization
  • Planned staged PCI within the subsequent 24 hours after index PCI
  • Use of abciximab within 7 days before randomization
  • Use of tirofiban or eptifibatide within 12 hours before randomization
  • Use of low-molecular weight heparin within 12 hours before randomization
  • Use of bivalirudin within 12 hours before randomization

Treatment and study plan

Short Tirofiban

Drug

25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.

Other names: Aggrastat

Eptifibatide

Drug

180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.

Other names: Integrilin

Long Tirofiban

Drug

25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI.

Other names: Aggrastat

Primary outcomes

  1. The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding

    Time frame: 48 hours or hospital discharge, whichever came first

    The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 3 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 bleeding criteria.

Secondary outcomes

  1. The Composite Endpoint of Death, Periprocedural Myonecrosis or Urgent Target Vessel Revascularization

    Time frame: 48 hours or hospital discharge, whichever came first

    The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 3 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), or urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia)

  2. Individual Components of Death, Urgent Target Revascularization or Major Bleeding

    Time frame: 48 hours or hospital discharge, whichever came first

    Individual components of death (any-cause), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 major bleeding criteria.

  3. Individual Components of Periprocedural Myonecrosis

    Time frame: 48 hours or hospital discharge, whichever came first

    Individual components of periprocedural myonecrosis (PPM) (defined as ≥ 3 times, ≥ 10 times, ≥ 20 times or ≥ 50 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value)

  4. The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM) (≥ 10x Troponin), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding

    Time frame: 48 hours or hospital discharge, whichever came first

    The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 10 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 bleeding criteria.

Sponsors and collaborators

Lead sponsor

Medicure

Industry

Collaborators

  • SCRI Development Innovations, LLC

Registry information

Official study title

A Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy of Tirofiban Using a High-Dose Bolus Plus a Shortened Infusion Duration Versus Label-Dosing Eptifibatide in Patients Undergoing Percutaneous Coronary Intervention

Acronym: SAVI-PCI

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
Jan 31, 2012
Registry last updated
May 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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