Clinical trial NCT01522417: Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocardial Infarction
Acute Coronary Syndromes
Unstable Angina
Lead sponsor: Medicure
Sponsor class: INDUSTRY
Collaborators: name: SCRI Development Innovations, LLC
First posted: 2012-01-31
Enrollment: 535
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding
timeFrame: 48 hours or hospital discharge, whichever came first
Secondary outcomes:
measure: The Composite Endpoint of Death, Periprocedural Myonecrosis or Urgent Target Vessel Revascularization
timeFrame: 48 hours or hospital discharge, whichever came first
measure: Individual Components of Death, Urgent Target Revascularization or Major Bleeding
timeFrame: 48 hours or hospital discharge, whichever came first
measure: Individual Components of Periprocedural Myonecrosis
timeFrame: 48 hours or hospital discharge, whichever came first
measure: The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM) (≥ 10x Troponin), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding
timeFrame: 48 hours or hospital discharge, whichever came first
Other outcomes:
Locations:
city: Kissimmee
country: United States
facility: Osceola Regional Medical Center
state: Florida
city: Saint Petersburg
country: United States
facility: Northside Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Gainesville
country: United States
facility: North Georgia Heart Center
state: Georgia
city: Rome
country: United States
facility: Redmond Regional Medical Center
state: Georgia
city: Thomasville
country: United States
facility: Archbold Medical Center
state: Georgia
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Centennial Heart
state: Tennessee
city: Richmond
country: United States
facility: Chippenham Hospital
state: Virginia
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Steven V Manoukian, MD
role: PRINCIPAL_INVESTIGATOR
References: