Myocardial InfarctionPhase 4NCT00288210
Sirolimus Eluting Stenting in Acute Myocardial Infarction
A Phase 4 study testing Primary angioplasty in acute myocardial infarction in people with Myocardial Infarction, run by San Camillo Hospital, Rome at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Primary angioplasty in acute myocardial infarction
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Mar 2003to Mar 2006
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study Of Sirolimus Eluting Stent Vs Conventional Stent In Acute Myocardial Infarction Acronym SESAMI
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.
Read the 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.
- Conditions
- Myocardial Infarction
- Being tested
- Primary angioplasty in acute myocardial infarction
- Keywords
- Myocardial Infarction, Stents, Sirolimus, abciximab
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary angioplasty in acute myocardial infarctionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point for the trial was the binary restonis at one year angiographic follow-up
Secondary outcomes (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startMar 2003
- Study completionMar 2006
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 Myocardial InfarctionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- San Camillo Hospital, Rome
- Sponsor type
- University, hospital or other
- Investigators
- Roberto Violini, MD, Study chair, Cardiologia Interventistica Ospedale San Camillo RomaMaurizio Menichelli, MD, Principal investigator, Cardiologia Interventistica Ospedale San Camillo Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288210
- Sponsor's protocol ID
- 183/2003
- Status last verified
- Feb 2006
- First submitted
- 6 Feb 2006
- Last updated
- 10 Feb 2006
- Results posted
- No
Publications
Menichelli M, Parma A, Pucci E, Fiorilli R, De Felice F, Nazzaro M, Giulivi A, Alborino D, Azzellino A, Violini R. Randomized trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI). J Am Coll Cardiol. 2007 May 15;49(19):1924-30. doi: 10.1016/j.jacc.2007.01.081. Epub 2007 Apr 30.
PubMed 17498576
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Of Sirolimus Eluting Stent Vs Conventional Stent In Acute Myocardial Infarction Acronym SESAMI
- ClinicalTrials.gov ID
- NCT00288210
- Acronym / sponsor ID
- 183/2003
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial Infarction, Stents, Sirolimus, abciximab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- San Camillo Hospital, RomeUniversity, hospital or other
- Study start
- Mar 2003
- Study completion
- Mar 2006
- First posted
- 7 Feb 2006 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
- -
Key exclusion criteria (2 listed)
- 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.
- -
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 |
|---|---|---|
| Primary angioplasty in acute myocardial infarction | Procedure or surgery | – |
Primary outcome
The primary end point for the trial was the binary restonis at one year angiographic follow-up
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2006.
- Derived from this study: PubMed 17498576Menichelli M, Parma A, Pucci E, Fiorilli R, De Felice F, Nazzaro M, Giulivi A, Alborino D, Azzellino A, Violini R. Randomized trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI). J Am Coll Cardiol. 2007 May 15;49(19):1924-30. doi: 10.1016/j.jacc.2007.01.081. Epub 2007 Apr 30.
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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.
Roberto Violini, MD study chair
Cardiologia Interventistica Ospedale San Camillo Roma
Maurizio Menichelli, MD principal investigator
Cardiologia Interventistica Ospedale San Camillo Roma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Primary angioplasty in acute myocardial infarction in people with Myocardial Infarction, run by San Camillo Hospital, Rome 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 2 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 10 Feb 2006. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end point for the trial was the binary restonis at one year angiographic follow-up. 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 NCT00288210, 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 10 Feb 2006.