Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention

NCT01522417 | Completed Phase 2 Results

• 1 other identifier: Medicure 11002
• Study Type: interventional
• Target: 535
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Myocardial Infarction; Acute Coronary Syndromes; Unstable Angina

Outcome Measures

Primary Outcomes (1)

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

  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.

  48 hours or hospital discharge, whichever came first

Secondary Outcomes (4)

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

  48 hours or hospital discharge, whichever came first

• Individual Components of Death, Urgent Target Revascularization or Major Bleeding

  48 hours or hospital discharge, whichever came first

• Individual Components of Periprocedural Myonecrosis

  48 hours or hospital discharge, whichever came first

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

  48 hours or hospital discharge, whichever came first

Study Arms (3)

Short Tirofiban (Aggrastat)

EXPERIMENTAL

Tirofiban (Aggrastat) will be dosed as a 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. Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).

Drug: Short Tirofiban

Eptifibatide (Integrilin)

ACTIVE COMPARATOR

Eptifibatide (Integrilin) will be dosed as a 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. Patients will receive eptifibatide (Integrilin) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).

Drug: Eptifibatide

Long Tirofiban (Aggrastat)

EXPERIMENTAL

Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI. Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines).

Drug: Long Tirofiban

Interventions

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.

Also known as: Aggrastat

Short Tirofiban (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.

Also known as: Integrilin

Eptifibatide (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.

Also known as: Aggrastat

Long Tirofiban (Aggrastat)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medicure: lead
• SCRI Development Innovations, LLC: collaborator

Study Sites (13)

Osceola Regional Medical Center

Kissimmee, Florida, 34741, United States

Location

Northside Hospital

St. Petersburg, Florida, 33709, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

North Georgia Heart Center

Gainesville, Georgia, 30501, United States

Location

Redmond Regional Medical Center

Rome, Georgia, 30165, United States

Location

Archbold Medical Center

Thomasville, Georgia, 31792, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Centennial Heart

Nashville, Tennessee, 37203, United States

Location

Chippenham Hospital

Richmond, Virginia, 23225, United States

Location

MeSH Terms

Conditions

Myocardial Infarction; Acute Coronary Syndrome; Angina, Unstable

Interventions

Tirofiban; Eptifibatide

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Peptides, Cyclic; Peptides

Limitations and Caveats

Randomization into the long tirofiban arm was initiated after 159 patients were already enrolled into either the short tirofiban or long eptifibatide arms.

Results Point of Contact

• Title: Kyle Brown
• Organization: Medicure

kbrown@medicure.com

204-594-3411

Study Officials

• Steven V Manoukian, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: January 31, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: May 13, 2021
• Results First Posted: April 20, 2021

Record last verified: 2021-04

Locations

US (13)