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Clinical Trials/NCT01478984
NCT01478984
Unknown
Phase 3

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

Gennaro Sardella1 site in 1 country247 target enrollmentOctober 2011

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Non ST Segment Elevation MI and Unstable Angina
Sponsor
Gennaro Sardella
Enrollment
247
Locations
1
Primary Endpoint
Major Adverese Cardiac and cerebral Events (MACCE)
Last Updated
14 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
October 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Gennaro Sardella

Associate Professor in Cardiology

University of Roma La Sapienza

Eligibility Criteria

Inclusion Criteria

  • diagnosis of NSTEMI
  • presenting with multivessel disease

Exclusion Criteria

  • patients with cardiogenic shock at presentation
  • left main coronary disease (\>50% diameter stenosis)
  • previous coronary artery bypass grafting (CABG) surgery
  • patients with Syntax Score \>32
  • candidated to by-pass surgery
  • severe valvular heart disease
  • unsuccessful procedures

Outcomes

Primary Outcomes

Major Adverese Cardiac and cerebral Events (MACCE)

Time Frame: 30 days

Incidence of major adverse cardiac and cerebrovascular events (MACCE) defined as cardiac or non-cardiac death, inhospital death, re-infarction, re-hospitalisation for acute coronary syndrome, repeat coronary revascularization and stroke at 30 days, 6 months and 1 year.

MACCE

Time Frame: 6 months

Incidence of major adverse cardiac and cerebrovascular events (MACCE) defined as cardiac or non-cardiac death, inhospital death, re-infarction, re-hospitalisation for acute coronary syndrome, repeat coronary revascularization and stroke at 30 days, 6 months and 1 year.

Study Sites (1)

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