Non ST Segment Elevation MI and Unstable Angina Clinical Trial
— SMILEOfficial title:
Impact of One Stage Compared With Multistaged PCI Complete Revascularization on Clinical Outcome in Multivessel NSTEMI Patients. Smile Trial
| NCT number | NCT01478984 |
| Other study ID # | SMILE |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 3 |
| First received | November 11, 2011 |
| Last updated | November 21, 2011 |
| Start date | October 2011 |
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.
| Status | Recruiting |
| Enrollment | 247 |
| Est. completion date | |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 95 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Dept.of Cardiovascular Sciences,Policlinico Umberto I | Rome |
| Lead Sponsor | Collaborator |
|---|---|
| Gennaro Sardella |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 12 months | Yes |
| Primary | 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. | 30 days | Yes |
| Primary | 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. | 6 months | Yes |