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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

247 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non ST Segment Elevation MI and Unstable Angina

Keywords

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NSTEMI PCI onestage multistaged

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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one staged PCI

the patient randomized to this arms complete the myocardial revascularization in one stage PCI, the investigators treat all lesions.

Group Type ACTIVE_COMPARATOR

One-Stage group

Intervention Type PROCEDURE

Patients randomized to One-Stage group were completely revascularizated in one time PCI,

multistaged PCI

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

Group Type ACTIVE_COMPARATOR

Multi-Staged group

Intervention Type PROCEDURE

patients randomized to Multi-Staged group were completely revascularizated in more time PCI, during the same hospitalization

Interventions

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One-Stage group

Patients randomized to One-Stage group were completely revascularizated in one time PCI,

Intervention Type PROCEDURE

Multi-Staged group

patients randomized to Multi-Staged group were completely revascularizated in more time PCI, during the same hospitalization

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Gennaro Sardella

Associate Professor in Cardiology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Dept.of Cardiovascular Sciences,Policlinico Umberto I

Rome, Rome, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Gennaro Sardella, MD

Role: CONTACT

Phone: +390649979035

Email: [email protected]

Facility Contacts

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Luigi Lucisano, MD

Role: primary

Massimo Mancone, MD, PhD

Role: backup

References

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Sardella G, Lucisano L, Garbo R, Pennacchi M, Cavallo E, Stio RE, Calcagno S, Ugo F, Boccuzzi G, Fedele F, Mancone M. Single-Staged Compared With Multi-Staged PCI in Multivessel NSTEMI Patients: The SMILE Trial. J Am Coll Cardiol. 2016 Jan 26;67(3):264-72. doi: 10.1016/j.jacc.2015.10.082.

Reference Type DERIVED

PMID: 26796390 (View on PubMed)

Other Identifiers

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SMILE

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

one staged PCI

One-Stage group

multistaged PCI

Multi-Staged group

Interventions

One-Stage group

Multi-Staged group

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Gennaro Sardella

Responsible Party

Gennaro Sardella

Locations

Dept.of Cardiovascular Sciences,Policlinico Umberto I

Countries

Central Contacts

Gennaro Sardella, MD

Facility Contacts

Luigi Lucisano, MD

Massimo Mancone, MD, PhD

References

Sardella G, Lucisano L, Garbo R, Pennacchi M, Cavallo E, Stio RE, Calcagno S, Ugo F, Boccuzzi G, Fedele F, Mancone M. Single-Staged Compared With Multi-Staged PCI in Multivessel NSTEMI Patients: The SMILE Trial. J Am Coll Cardiol. 2016 Jan 26;67(3):264-72. doi: 10.1016/j.jacc.2015.10.082.

Other Identifiers

SMILE