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Sirolimus Eluting Stenting in Acute Myocardial Infarction

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2006 by San Camillo Hospital, Rome.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00288210
First Posted: February 7, 2006
Last Update Posted: February 10, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
San Camillo Hospital, Rome
  Purpose
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.

Condition Intervention Phase
Myocardial Infarction Procedure: Primary angioplasty in acute myocardial infarction Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study Of Sirolimus Eluting Stent Vs Conventional Stent In Acute Myocardial Infarction Acronym SESAMI

Resource links provided by NLM:


Further study details as provided by San Camillo Hospital, Rome:

Primary Outcome Measures:
  • The primary end point for the trial was the binary restonis at one year angiographic follow-up

Secondary Outcome Measures:
  • Secondary end points included a composite of
  • 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

Study Start Date: March 2003
Estimated Study Completion Date: March 2006
Detailed 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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288210


Locations
Italy
Cardiologia Interventistica Ospedale San Camillo
Roma, Italy, 00100
Sponsors and Collaborators
San Camillo Hospital, Rome
Investigators
Study Chair: Roberto Violini, MD Cardiologia Interventistica Ospedale San Camillo Roma
Principal Investigator: Maurizio Menichelli, MD Cardiologia Interventistica Ospedale San Camillo Roma
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00288210     History of Changes
Other Study ID Numbers: 183/2003
First Submitted: February 6, 2006
First Posted: February 7, 2006
Last Update Posted: February 10, 2006
Last Verified: February 2006

Keywords provided by San Camillo Hospital, Rome:
Myocardial Infarction
Stents
Sirolimus
abciximab

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs