Myocardial InfarctionPhase 4ZEST-AMINCT00422565
Zotarolimus-Versus Sirolimus-Versus PacliTaxel-Eluting Stent for Acute Myocardial Infarction Patients
A Phase 4 study testing Endeavor, Medtronic, Cypher, Cordis and Taxus Liberte, Boston Scientific in people with Myocardial Infarction, run by Seung-Jung Park at 12 sites in South Korea.
Trial summary
The trial has the following primary objective: To compare the safety and effectiveness of primary acute MI intervention with ABT 578-eluting balloon expandable stent (Medtronic, Minneapolis, MN) vs. sirolimus-eluting balloon expandable stent (Cordis Johnson \& Johnson, Warren, New Jersey) vs. 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?
- Endeavor, Medtronic, Cypher, Cordis and Taxus Liberte, Boston Scientific
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 12 sitesSouth Korea
- Study dates
- Oct 2006to Sep 2008
- 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
- The patient must be at least 18 years of age.
- Culprit de novo lesion in a native coronary artery with significant stenosis (>50% by visual estimate) eligible for stent implantation (no limitation on stent length)
- Prolonged, continuous (≥ 20 min) chest pain despite nitrate and: (1) at least 1mm ST-segment elevation in at least 2 leads or reciprocal ST-segment depression ≥ 2 contiguous precordial leads, or (2) newly developed left bundle branch block
- Symptoms < 12 hours
- The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Who cannot join
- The patient has a known hypersensitivity or contraindication to any of the following medications:
- Heparin
- Aspirin
- Both Clopidogrel and TIclopidine
- Sirolimus, paclitaxel, ABT 578
- Stainless steel and/or
Show all 19Show fewer
- Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
- Systemic (intravenous) Sirolimus, paclitaxel or ABT-578 use within 12 months.
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- Fibrinolytic therapy for current MI treatment
- Previous coronary intervention on target vessel
- Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- Previously documented LVEF <30%.
- Evident cardiogenic shock before randomization
- Patients with left main stem stenosis (>50% by visual estimate)
- Severe calcification or tortuosity
- Multi-vessel disease with non-culprit vessel requiring bypass surgery
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites
Soonchunhyang University Bucheon Hospital
Bucheon-si
Daegu Catholic University Medical Center
Daegu
Chungnam National University Hospital
Daejeon
Asan Medical Center
Gangneung
Chonnam National University Hospital
Gwangju
NHIC Ilsan Hospital
Ilsan
Pusan Natioanal University Hospital
Pusan
Asan Medical Center
Seoul, 138-732
Korea University Hospital
Seoul
St. Mary's Catholic Medical Center
Seoul
Ulsan University Hospital
Ulsan
Yonsei University Wonju Christian Hospital
Wŏnju
About this study
Official title: Comparison of the Efficacy and Safety of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent Versus PacliTaxel-Eluting Stent for Acute Myocardial Infarction Patients
The trial has the following primary objective:
To compare the safety and effectiveness of primary acute MI intervention with ABT 578-eluting balloon expandable stent (Medtronic, Minneapolis, MN) vs. sirolimus-eluting balloon expandable stent (Cordis Johnson \& Johnson, Warren, New Jersey) vs. paclitaxel-eluting stent (Taxus Liberte, Boston Scientific).
Read the detailed description
Previous studies have documented that a slow-release polymeric sirolimus-eluting stent (Cypher, Cordis) and paclitaxel-eluting stent (Taxus, Boston Scientific) reduce neointimal formation and result in decrease of angiographic restenosis and target lesion revascularization at 1-3 years in the multicenter randomized clinical trials RAVEL, SIRIUS, and TAXUS I-VI. From these studies, the two leading drug-eluting stents (DESs) of the Cypher and Taxus have been widely and rapidly accepted as a standard treatment of coronary lesions.
Recently, randomized studies were conducted to reveal different outcomes of the different two DESs. These studies showed that the sirolimus-eluting stent was better than the paclitaxel-eluting stent in terms of lower angiographic restenosis rate or the two DESs were similar in angiographic outcomes. A recent meta-analysis supported results of the former randomized studies. Patients receiving sirolimus-eluting stent had a significantly lower risk of restenosis and target vessel revascularization compared with those receiving paclitaxel-eluting stent.
With a recent approval of new DES, ABT-578-eluting stent (Endeavor, Medtronic, Minneapolis, MN), other comparison studies have been conducted to compare Endeavor ABT-578-eluting stent with the sirolimus-eluting stent and paclitaxel-eluting stent. The ENDEAVOR clinical trials are currently in progress to evaluate a phosphoryl choline (PC)-coated ABT-578-eluting stent for the prevention of restenosis. Angiographic analysis at 4 months in the 100-patient focal de novo lesion ENDEAVOR I feasibility study demonstrated a mean in-stent percent diameter stenosis of approximately 14% and a late lumen loss of 0.3 mm with a low frequency of target lesion revascularization (1%). The clinical outcomes from the ENDEAVOR II (1,197 patients randomized to ABT-578 or bare metal stent) showed superior efficacy of the PC-coated ABT-578-eluting stent than bare-metal stent.
In patients with acute myocardial infraction (MI), routine stent implantation has been shown to have a better procedural success rate and clinical outcome than balloon angioplasty [11]. However, restenosis and vessel reocclusion remain major challenges limiting the long-term success of percutaneous treatment.
In a clinical study of 400 patients with stent implantation in acute MI, angiographic restenosis occurred in 31%, considerably more than expected for patients with stable coronary disease. There is very little information available as to the efficacy and long-term safety of DES in acute MI. The results from the several registry and randomized trials (Cypher-AMI, Typhoon, PASSION) demonstrated the short-term or long-term safety and efficacy of DES compared to BMS.
The incomplete evidence to date is that implantation of SES in patients with Acute MI is safe and effective more than BMS and results of implantation of PES are at variance with the results of the BMS. However, up to date, there are randomized trials to compare the efficacy and safety among commonly used DES (zotarolimus- vs. sirolimus- vs. paclitaxel-eluting stents) for the treatment of acute MI patients. The results of large randomized trials and larger registries will allow us to make evidence-based decisions about which stent to use in patients with acute MI. Therefore, we designed a randomized, controlled, partially blinded trial comparing the safety and efficacy of the zotarolimus vs. sirolimus vs. paclitaxel stents in acute MI patients undergoing percutaneous coronary intervention.
- Conditions
- Myocardial Infarction
- Being tested
- Endeavor, Medtronic, Cypher, Cordis, Taxus Liberte, Boston Scientific
- Keywords
- Coronary Artery Disease, Stent, Myocardial Infarction
- Medical subject headings
- Myocardial Infarction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endeavor, MedtronicDevice
Also called Zotarolimus-eluting stent
Zotarolimus-eluting stent
Cypher, CordisDevice
Also called Sirolimus-eluting stent
Sirolimus-eluting stent
Taxus Liberte, Boston ScientificDevice
Also called Paclitaxel-eluting stent
Paclitaxel-eluting stent
| Study group | Role | What they receive |
|---|---|---|
| Endeavor | Experimental | Zotarolimus-eluting stent Receives: Device: Endeavor, Medtronic |
| Cypher | Active comparator | Sirolimus-eluting stent Receives: Device: Cypher, Cordis |
| Taxus | Active comparator | Paclitaxel-eluting stent Receives: Device: Taxus Liberte, Boston Scientific |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite of death (all cause-mortality), MI (Q wave and non Q wave) and ischemia-driven target vessel revascularization.
Measured: At 12 months after the index procedure
Secondary outcomes (9)
All-cause Death
Measured: 1 month, 6 month, 1 year and thereafter annaully up to 5 years
Cardiac death
Measured: 1 month, 6 month, 1 year and thereafter annaully up to 5 years
Recurrent Myocardial infarction
Measured: 1 month, 6 month, 1 year and thereafter annaully up to 5 years
Target vessel revascularization (all and ischemia-driven)
Measured: 1 month, 6 month, 1 year and thereafter annaully up to 5 years
Target lesion revascularization (all and ischemia-driven)
Measured: 1 month, 6 month, 1 year and thereafter annaully up to 5 years
Stent thrombosis for the patients
Measured: 1 month, 6 month, 1 year and thereafter annaully up to 5 years
Late luminal loss in both in-stent and in-segment
Measured: at 8 month angiographic follow-up
Binary restenosis in both in-stent and in-segment
Measured: at 8 month angiographic follow-up
Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion
Measured: during the hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
- Study startOct 2006
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: The recruitment rate was much slower than expected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- Cordis US Corp., CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, CardioVascular Research Foundation, Korea
- Investigators
- Seung-Jung Park, MD, PhD, Principal investigator, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422565
- Sponsor's protocol ID
- 2006-0137
- Acronym
- ZEST-AMI
- Status last verified
- Dec 2022
- First submitted
- 16 Jan 2007
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent Versus PacliTaxel-Eluting Stent for Acute Myocardial Infarction Patients
- ClinicalTrials.gov ID
- NCT00422565
- Acronym / sponsor ID
- ZEST-AMI / 2006-0137
- Conditions
- Myocardial Infarction
- Keywords
- Coronary Artery Disease, Stent, Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The recruitment rate was much slower than expected.
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- Cordis US Corp., CardioVascular Research Foundation, Korea
- Study start
- Oct 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 17 Jan 2007 (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 trial has the following primary objective:
To compare the safety and effectiveness of primary acute MI intervention with ABT 578-eluting balloon expandable stent (Medtronic, Minneapolis, MN) vs. sirolimus-eluting balloon expandable stent (Cordis Johnson \& Johnson, Warren, New Jersey) vs. paclitaxel-eluting stent (Taxus Liberte, Boston Scientific).
Detailed description
Previous studies have documented that a slow-release polymeric sirolimus-eluting stent (Cypher, Cordis) and paclitaxel-eluting stent (Taxus, Boston Scientific) reduce neointimal formation and result in decrease of angiographic restenosis and target lesion revascularization at 1-3 years in the multicenter randomized clinical trials RAVEL, SIRIUS, and TAXUS I-VI. From these studies, the two leading drug-eluting stents (DESs) of the Cypher and Taxus have been widely and rapidly accepted as a standard treatment of coronary lesions.
Recently, randomized studies were conducted to reveal different outcomes of the different two DESs. These studies showed that the sirolimus-eluting stent was better than the paclitaxel-eluting stent in terms of lower angiographic restenosis rate or the two DESs were similar in angiographic outcomes. A recent meta-analysis supported results of the former randomized studies. Patients receiving sirolimus-eluting stent had a significantly lower risk of restenosis and target vessel revascularization compared with those receiving paclitaxel-eluting stent.
With a recent approval of new DES, ABT-578-eluting stent (Endeavor, Medtronic, Minneapolis, MN), other comparison studies have been conducted to compare Endeavor ABT-578-eluting stent with the sirolimus-eluting stent and paclitaxel-eluting stent. The ENDEAVOR clinical trials are currently in progress to evaluate a phosphoryl choline (PC)-coated ABT-578-eluting stent for the prevention of restenosis. Angiographic analysis at 4 months in the 100-patient focal de novo lesion ENDEAVOR I feasibility study demonstrated a mean in-stent percent diameter stenosis of approximately 14% and a late lumen loss of 0.3 mm with a low frequency of target lesion revascularization (1%). The clinical outcomes from the ENDEAVOR II (1,197 patients randomized to ABT-578 or bare metal stent) showed superior efficacy of the PC-coated ABT-578-eluting stent than bare-metal stent.
In patients with acute myocardial infraction (MI), routine stent implantation has been shown to have a better procedural success rate and clinical outcome than balloon angioplasty [11]. However, restenosis and vessel reocclusion remain major challenges limiting the long-term success of percutaneous treatment.
In a clinical study of 400 patients with stent implantation in acute MI, angiographic restenosis occurred in 31%, considerably more than expected for patients with stable coronary disease. There is very little information available as to the efficacy and long-term safety of DES in acute MI. The results from the several registry and randomized trials (Cypher-AMI, Typhoon, PASSION) demonstrated the short-term or long-term safety and efficacy of DES compared to BMS.
The incomplete evidence to date is that implantation of SES in patients with Acute MI is safe and effective more than BMS and results of implantation of PES are at variance with the results of the BMS. However, up to date, there are randomized trials to compare the efficacy and safety among commonly used DES (zotarolimus- vs. sirolimus- vs. paclitaxel-eluting stents) for the treatment of acute MI patients. The results of large randomized trials and larger registries will allow us to make evidence-based decisions about which stent to use in patients with acute MI. Therefore, we designed a randomized, controlled, partially blinded trial comparing the safety and efficacy of the zotarolimus vs. sirolimus vs. paclitaxel stents in acute MI patients undergoing percutaneous coronary intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endeavor | Experimental | Device: Endeavor, MedtronicZotarolimus-eluting stent |
| Cypher | Active comparator | Device: Cypher, CordisSirolimus-eluting stent |
| Taxus | Active comparator | Device: Taxus Liberte, Boston ScientificPaclitaxel-eluting stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient must be at least 18 years of age.
- Culprit de novo lesion in a native coronary artery with significant stenosis (>50% by visual estimate) eligible for stent implantation (no limitation on stent length)
- Prolonged, continuous (≥ 20 min) chest pain despite nitrate and: (1) at least 1mm ST-segment elevation in at least 2 leads or reciprocal ST-segment depression ≥ 2 contiguous precordial leads, or (2) newly developed left bundle branch block
- Symptoms < 12 hours
- The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Key exclusion criteria (19 listed)
- The patient has a known hypersensitivity or contraindication to any of the following medications:
- Systemic (intravenous) Sirolimus, paclitaxel or ABT-578 use within 12 months.
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- Fibrinolytic therapy for current MI treatment
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 |
|---|---|---|
| Endeavor, MedtronicAlso: Zotarolimus-eluting stentZotarolimus-eluting stent | Device | Endeavor |
| Cypher, CordisAlso: Sirolimus-eluting stentSirolimus-eluting stent | Device | Cypher |
| Taxus Liberte, Boston ScientificAlso: Paclitaxel-eluting stentPaclitaxel-eluting stent | Device | Taxus |
Primary outcome
The composite of death (all cause-mortality), MI (Q wave and non Q wave) and ischemia-driven target vessel revascularization.
Time frame: At 12 months after the index procedure
9 secondary outcomes
All-cause Death
Time frame: 1 month, 6 month, 1 year and thereafter annaully up to 5 years
Cardiac death
Time frame: 1 month, 6 month, 1 year and thereafter annaully up to 5 years
Recurrent Myocardial infarction
Time frame: 1 month, 6 month, 1 year and thereafter annaully up to 5 years
Target vessel revascularization (all and ischemia-driven)
Time frame: 1 month, 6 month, 1 year and thereafter annaully up to 5 years
Target lesion revascularization (all and ischemia-driven)
Time frame: 1 month, 6 month, 1 year and thereafter annaully up to 5 years
Stent thrombosis for the patients
Time frame: 1 month, 6 month, 1 year and thereafter annaully up to 5 years
Late luminal loss in both in-stent and in-segment
Time frame: at 8 month angiographic follow-up
Binary restenosis in both in-stent and in-segment
Time frame: at 8 month angiographic follow-up
Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion
Time frame: during the hospital stay
Results and safety
The study was stopped early (reason given: The recruitment rate was much slower than expected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
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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.
Seung-Jung Park, MD, PhD principal investigator
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Endeavor, Medtronic, Cypher, Cordis and Taxus Liberte, Boston Scientific in people with Myocardial Infarction, run by Seung-Jung Park at 12 sites in South Korea.
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 5 inclusion and 19 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: stopped early, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in South Korea. 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?
The study was stopped early (reason given: The recruitment rate was much slower than expected.). 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 composite of death (all cause-mortality), MI (Q wave and non Q wave) and ischemia-driven target vessel revascularization. (time frame: At 12 months after the index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2022.