Sirolimus Eluting Stenting in Acute Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:

Randomized Study Of Sirolimus Eluting Stent Vs Conventional Stent In Acute Myocardial Infarction Acronym SESAMI

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00288210
• Other study ID #: 183/2003
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 6, 2006
• Last updated: February 9, 2006
• Start date: March 2003
• Est. completion date: March 2006

Study information

• Verified date: February 2006
• Source: San Camillo Hospital, Rome
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The incidence of stent restenosis in the setting of primary angioplasty is particularly high, reaching a rate of 27% In the last years the introduction of drug-eluting stents has drastically reduced the incidence of restenosis in patients not requiring urgent revascularization. Whether drug-eluting stenting might constitute the new optimal therapy for patients with an acute myocardial infarction is unknown. To be able to answer this question, we designed a randomized trial in which patients with an acute myocardial infarction eligible for treatment with primary angioplasty and abciximab were randomized to receive either a rapamicine-eluting stent or a conventional bare stent.

Description:

The treatment of acute myocardial infarction has evolved dramatically in the last decade. Coronary angioplasty with stent implantation in conjunction with an optimal antitrombotic therapy as abciximab is now considered current standard therapy However, the incidence of stent restenosis in the setting of primary angioplasty remains particularly high, reaching a rate of 27%. A high restenosis rate causes a high re-hospitalization rate for target vessel revascularization and an ensuing increase in cost.In the last years the introduction of drug-eluting stents has drastically reduced the incidence of restenosis in patients not requiring urgent revascularization. This reduced incidence of restenosis occurs without an increase in adverse clinical events over conventional stents and has a very low rate of stent subacute thrombosis. Whether this combination of drug-eluting stents and abciximab might constitute the new optimal therapy for patients with an acute myocardial infarction is unknown. To be able to answer this question, we designed a one year coronary angiographic study in which patients with an acute myocardial infarction eligible for treatment with primary angioplasty and abciximab were randomized to receive either a rapamicine-eluting stent or a conventional bare stent.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Inclusion criteria were an age of more than 18 years, the presence for at least 30 minutes but less than 12 hours of symptoms consistent with acute myocardial infarction, and the presence of ST-segment elevation in at least two contiguous leads or left bundle-branch block.

Exclusion Criteria:

Patients were excluded if they were in cardiogenic shock (defined as systolic blood pressure of less than 80 mm Hg for more than 30 minutes or the need for intravenous pressors or intraaortic-balloon counterpulsation); had a history of bleeding diathesis; had a history of leukopenia, thrombocytopenia, or severe hepatic or renal dysfunction; had a noncardiac illness associated with a life expectancy of less than one year; were participating in another study; or were unable to give informed consent owing to prolonged cardiopulmonary resuscitation.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Procedure:
• Primary angioplasty in acute myocardial infarction

Locations

Country	Name	City	State
Italy	Cardiologia Interventistica Ospedale San Camillo	Roma

Sponsors (1)

Lead Sponsor	Collaborator
San Camillo Hospital, Rome

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end point for the trial was the binary restonis at one year angiographic follow-up
Secondary	Secondary end points included a composite of
Secondary	MACE including death, Q-wave and non–Q-wave infarction, emergent bypass surgery, or repeat TLR at 30 days and 12 months after the index procedure