NCT01478984

Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction (NSTEMI) Patients: One Stage Versus Multistaged Percutaneous Coronary Intervention (PCI)

Impact of One Stage Compared With Multistaged PCI Complete Revascularization on Clinical Outcome in Multivessel NSTEMI Patients. Smile Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 247 (estimated)
• Sponsor: Gennaro Sardella · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

Patients with NSTEMI and multivessel disease will be scheduled to undergo early invasive strategy (PCI within 72 hours) of de novo native coronary artery lesions were considered for recruitment into the study. Inclusion criteria are the following: diagnosis of NSTEMI according to current guidelines presenting with multivessel disease. We will exclude patients with cardiogenic shock at presentation (systolic blood pressure \<90 mmHg despite drug therapy), left main coronary disease (\>50% diameter stenosis), previous coronary artery bypass grafting (CABG) surgery, patients with Syntax Score \>32 and candidated to by-pass surgery (10), severe valvular heart disease and unsuccessful procedures. Procedure success was defined as the achievement of an angiographic residual stenosis of less than 30% and a thrombolysis in myocardial infarction (TIMI) flow grade III after PCI. Patients randomized to One-Stage group were completely revascularizated in one time PCI, whereas patients randomized to Multi-Staged group were completely revascularizated in more time PCI, during the same hospitalization. Patients received a clopidogrel loading dose of 600 mg before the PCI (for loading dose administered more than 6 h prior to procedure). Post-procedural antiplatelet regimen consisted of aspirin at 100 mg/day indefinitely and clopidogrel 75 mg/day for at least one month.

Conditions

• Non ST Segment Elevation MI and Unstable Angina

Interventions

Type	Name	Description
PROCEDURE	One-Stage group	Patients randomized to One-Stage group were completely revascularizated in one time PCI,
PROCEDURE	Multi-Staged group	patients randomized to Multi-Staged group were completely revascularizated in more time PCI, during the same hospitalization

Timeline

• Start date: 2011-10-01
• Primary completion: 2011-10-01
• First posted: 2011-11-24
• Last updated: 2011-11-24

Locations

1 site across 1 country: Italy