Phase 2 N=535 Randomized Treatment

Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention

Myocardial Infarction · Acute Coronary Syndromes · Unstable Angina

Bottom Line

View on ClinicalTrials.gov: NCT01522417 ↗

Enrolled (actual)

535

Serious AEs

4.9%

Results posted

Apr 2021

Primary outcome: Primary: The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding — 69; 60; 48 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Short Tirofiban (Drug); Eptifibatide (Drug); Long Tirofiban (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medicure
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding	69; 60; 48	—
SECONDARY The Composite Endpoint of Death, Periprocedural Myonecrosis or Urgent Target Vessel Revascularization	69; 60; 45	—
SECONDARY Individual Components of Death, Urgent Target Revascularization or Major Bleeding	0; 1; 0; 1; 0; 1	—
SECONDARY Individual Components of Periprocedural Myonecrosis	69; 60; 45; 36; 35; 28	—
SECONDARY The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM) (≥ 10x Troponin), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding	36; 35; 32	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01522417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.