NCT01454440

The INtegrilin Plus STenting to Avoid Myocardial Necrosis Trial (INSTANT)

A RANDOMIZED TRIAL COMPARING EPTIFIBATIDE AND PLACEBO IN PATIENTS WITH DIFFUSE CORONARY DISEASE UNDERGOING DRUG-ELUTING STENTING

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with stable coronary artery disease, undergoing PCI by means of implantation of \>33 mm of DES, will be randomized single-blinded to eptifibatide plus unfractioned heparin according to the ESPRIT protocol vs placebo plus unfractioned heparin.

Detailed description

BACKGROUND: Despite the availability of several potent antithrombotic agents, the optimal antiplatelet regimen in elective patients undergoing complex percutaneous coronary interventions is still debated. Aim of the INtegrilin plus STenting to Avoid myocardial Necrosis Trial (INSTANT) will be to assess the safety and efficacy of routine usage of the glycoprotein IIb/IIIa inhibitor eptifibatide in subjects already treated with aspirin and clopidogrel, and undergoing implantation of at least 2 drug-eluting stents in the same lesion, thus identifying a clinically stable but anatomically complex patient subset. DESIGN: This will be a single-blind, placebo-controlled multicenter randomized trial METHODS: Patients with stable coronary artery disease, undergoing percutaneous coronary intervention (PCI) by means of implantation of \>33 mm of DES (eg with two 23-mm DES, or one 32-mm and one 12-mm DES), will be randomized, after administration of aspirin and clopidogrel (600 mg loading dose recommended), to eptifibatide and unfractioned heparin according to the ESPRIT protocol vs placebo and unfractioned heparin. Blood draws for CK-MB mass, total CK and cardiac troponin levels will be taken at baseline, 6 and 12 hours post-procedurally. Patients will be followed for clinical events by direct visit or phone contact up to 6 months. The primary end-point of the study will be the rate of abnormal post-PCI CK-MB mass values. Secondary end-points will be: the composite of cardiac death, non-fatal myocardial infarction (MI), urgent target vessel revascularization (TVR), and thrombotic bailout GpIIb/IIIa inhibitor therapy within 180 days, and in-hospital, 1-month and 6-month major adverse cardiovascular events (MACE), defined as the composite of cardiac death, non-fatal MI, or urgent TVR. IMPLICATIONS: The INSTANT Study will test for the first time the beneficial impact of routine GpIIb/IIIa inhibition on top of double oral antiplatelet treatment in clinically stable yet anatomically complex patients undergoing DES-implantation. Results of this single-blind randomized trial will provide important insights to improve the management strategy of patients and outcomes in the current DES era.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Eptifibatide	Intravenous eptifibatide (double bolus \[180 microg/kg\] followed by infusion \[2 microg/kg per minute\] for 18 to 24 hours after the procedure) vs placebo.

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2011-10-19
• Last updated: 2011-10-19

Locations

1 site across 1 country: Italy