Non ST Segment Elevation MI and Unstable AnginaPhase 3SMILENCT01478984
Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction (NSTEMI) Patients: One Stage Versus Multistaged Percutaneous Coronary Intervention (PCI)
A Phase 3 study testing One-Stage group and Multi-Staged group in people with Non ST Segment Elevation MI and Unstable Angina, run by Gennaro Sardella at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Non ST Segment Elevation MI and Unstable Angina
- What is being tested?
- One-Stage group and Multi-Staged group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2011to Oct 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of NSTEMI
- presenting with multivessel disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Dept.of Cardiovascular Sciences,Policlinico Umberto I
Rome, Rome, 00161
Luigi Lucisano, MD, +390649979044, luigilucisano@yahoo.it
Massimo Mancone, MD, PhD, +390649979044, massimomancone@gmail.com
About this study
Official title: Impact of One Stage Compared With Multistaged PCI Complete Revascularization on Clinical Outcome in Multivessel NSTEMI Patients. Smile Trial
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.
- Being tested
- One-Stage group, Multi-Staged group
- Keywords
- NSTEMI, PCI, onestage, multistaged
- Medical subject headings
- Angina, Unstable, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-Stage groupProcedure or surgery
Patients randomized to One-Stage group were completely revascularizated in one time PCI,
Multi-Staged groupProcedure or surgery
patients randomized to Multi-Staged group were completely revascularizated in more time PCI, during the same hospitalization
| Study group | Role | What they receive |
|---|---|---|
| one staged PCI | Active comparator | the patient randomized to this arms complete the myocardial revascularization in one stage PCI, the investigators treat all lesions. Receives: Procedure: One-Stage group |
| 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 Receives: Procedure: Multi-Staged group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverese Cardiac and cerebral Events (MACCE)
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.
Measured: 12 months
Major Adverese Cardiac and cerebral Events (MACCE)
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.
Measured: 30 days
MACCE
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non ST Segment Elevation MI and Unstable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 247 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gennaro Sardella
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gennaro Sardella, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478984
- Sponsor's protocol ID
- SMILE
- Acronym
- SMILE
- Status last verified
- Nov 2011
- First submitted
- 11 Nov 2011
- Last updated
- 24 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26796390
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of One Stage Compared With Multistaged PCI Complete Revascularization on Clinical Outcome in Multivessel NSTEMI Patients. Smile Trial
- ClinicalTrials.gov ID
- NCT01478984
- Acronym / sponsor ID
- SMILE / SMILE
- Keywords
- NSTEMI, PCI, onestage, multistaged
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 247 participants (estimated)
- Lead sponsor
- Gennaro SardellaUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2011 (actual)
- First posted
- 24 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one staged PCI | Active comparator | Procedure: One-Stage groupthe patient randomized to this arms complete the myocardial revascularization in one stage PCI, the investigators treat all lesions. |
| multistaged PCI | Active comparator | Procedure: Multi-Staged groupthe 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 |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of NSTEMI
- presenting with multivessel disease
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One-Stage groupPatients randomized to One-Stage group were completely revascularizated in one time PCI, | Procedure or surgery | one staged PCI |
| Multi-Staged grouppatients randomized to Multi-Staged group were completely revascularizated in more time PCI, during the same hospitalization | Procedure or surgery | multistaged PCI |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2011.
- Derived from this study: PubMed 26796390Sardella 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing One-Stage group and Multi-Staged group in people with Non ST Segment Elevation MI and Unstable Angina, run by Gennaro Sardella at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gennaro Sardella, MD (+390649979035, rino.sardella@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverese Cardiac and cerebral Events (MACCE) (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01478984, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2011.