---
title: "Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction (NSTEMI) Patients: One Stage Versus Multistaged Percutaneous Coronary Intervention (PCI)"
nct_id: NCT01478984
overall_status: UNKNOWN
phase: PHASE3
sponsor: Gennaro Sardella
study_type: INTERVENTIONAL
primary_condition: Non ST Segment Elevation MI and Unstable Angina
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01478984.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01478984"
ct_last_update_post_date: 2011-11-24
last_seen_at: "2026-05-12T06:41:49.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction (NSTEMI) Patients: One Stage Versus Multistaged Percutaneous Coronary Intervention (PCI)

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

**NCT ID:** [NCT01478984](https://clinicaltrials.gov/study/NCT01478984)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 247
- **Lead Sponsor:** Gennaro Sardella
- **Conditions:** Non ST Segment Elevation MI and Unstable Angina
- **Start Date:** 2011-10
- **CT.gov Last Update:** 2011-11-24

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 95 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **one staged PCI** (ACTIVE_COMPARATOR) — the patient randomized to this arms complete the myocardial revascularization in one stage PCI, the investigators treat all lesions.
- **multistaged PCI** (ACTIVE_COMPARATOR) — the patients randomized to this arms in the first stage the investigators treat only the culprit lesion and in second stage the investigators treat the other vessels

## Interventions

- **One-Stage group** (PROCEDURE) — Patients randomized to One-Stage group were completely revascularizated in one time PCI,
- **Multi-Staged group** (PROCEDURE) — patients randomized to Multi-Staged group were completely revascularizated in more time PCI, during the same hospitalization

## Primary Outcomes

- **Major Adverese Cardiac and cerebral Events (MACCE)** _(time frame: 12 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.
- **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.

## Locations (1)

- Dept.of Cardiovascular Sciences,Policlinico Umberto I, Rome, Rome, Italy — _RECRUITING_

## Recent Field Changes (last 30 days)

- `eligibility.minAge` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.dept.of cardiovascular sciences,policlinico umberto i|rome|rome|italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01478984.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01478984*  
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