Efficacy of Everolimus-Eluting Versus Zotarolimus-Eluting Sten for Coronary Lesions in Acute Myocardial Infarction (EVERZOTA)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Yonsei University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Yonsei University
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01347554
First received: April 27, 2011
Last updated: July 12, 2011
Last verified: February 2011
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Purpose
Most of the previous data regarding the efficacy of the everolimus-eluting stent (EES) was derived from studies comparing EES with bare metal stent (BMS) or EES with paclitaxel-eluting (PES). Although sirolimus-eluting stents (SES) have been shown to be the most efficacious drug regarding inhibition of neointima and late loss, there have been no previous head to head comparisons between EES and zotarolimus-eluting stent (ZES). Both everolimus and sirolimus are macrocyclic lactones that target the mTOR (mammalian target of rapamycin) to reduce vascular smooth muscle proliferation after vessel injury and therefore in principle may show similar results after stenting in humans. Data pooled from the EES arm that received follow up angiography in the SPIRIT III trial and the SES arm in the SIRIUS trial show similar rates of binary restenosis and late loss. However, the stent and polymer platform is not the same between the EES and ZES and it is reported that the EES system has the thinnest stent + polymer thickness (88.6um) of all of the previously KFDA-approved drug-eluting stent (DES). In addition, there are no data available on the efficacy of the EES and ZES in "real world" lesions other than the selected lesions studied in the previous trials, such as acute myocardial infarction.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction |
Device: Everolimus stent (Xience V) Device: Zotarolimus stent (Endeavor resolute) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of the Efficacy of Everolimus-Eluting Versus Zotarolimus-Eluting Stent for Coronary Lesions in Acute Myocardial Infarction |
Resource links provided by NLM:
Further study details as provided by Yonsei University:
Primary Outcome Measures:
- Major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, ischemia driven target lesion revascularization at 12 months. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Individual components of safety issue [ Time Frame: Two years ] [ Designated as safety issue: Yes ]All Death/Cardiac death
- Individual components of safety issue [ Time Frame: Two years ] [ Designated as safety issue: Yes ]Bleeding
- Individual components of efficacy issue [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Myocardial infarction (Q-wave and non-Q wave)
- Individual components of efficacy issue [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Target vessel revascularization (TVR)
- Individual components of efficacy issue [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Target lesion revascularization (TLR)
- Individual components of efficacy issue [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Stent thrombosis
- Individual components of efficacy issue [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Acute success
- Individual components of efficacy issue [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]In-segment late luminal loss (LL) at 9~12 months
- Individual components of efficacy issue [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]In-stent late loss at 9~12 months
- Individual components of efficacy issue [ Time Frame: 12 months ] [ Designated as safety issue: No ]Angiographic pattern of restenosis at 9~12 months angiographic follow-up
- Individual components of efficacy issue [ Time Frame: 12 months ] [ Designated as safety issue: No ]In-stent and in-segment % diameter stenosis (%DS) at 9~12 months
- Individual components of efficacy issue [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]MACE at 24 months
| Enrollment: | 500 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Xience V stent group
Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
|
Device: Everolimus stent (Xience V)
Everolimus eluting stent stenting
Other Name: Xience V
|
|
Active Comparator: Endeavor resolute group
Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
|
Device: Zotarolimus stent (Endeavor resolute)
Zotarolimus eluting stent stenting
Other Name: Endeavor resolute
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age > 18 years
- Chest pain duration more than 10 minutes
- At least on of the following criteria
- A. ECG change (T inversion, ST depression and ST elevation)
- B. Cardiac enzyme elevation more than upper normal limit
- Significant coronary artery stenosis (>50% by visual estimate)
- The patient or guardian agrees to the study
Exclusion Criteria:
- Stent thrombosis
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions
- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months
- An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 12 months post enrollment
- 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)
- Severe infective state
- Patients with LVEF <25% or those with cardiogenic shock
- Lt. main MI
- Creatinine level more than 3.0mg/dL or dependence on dialysis
- Severe hepatic dysfunction (AST and ALT 3 times upper normal limit)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347554
Locations
| Korea, Republic of | |
| Yonsei University Wonju College of Medicine; Wonju Christian Hospital | |
| Wonju, Korea, Republic of | |
Sponsors and Collaborators
Yonsei University
Investigators
| Principal Investigator: | Seung-Hwan Lee, MD, PhD | Division of cardiology, Department of internal medicine, Wonju christian hospital, Yonsei University Wonju College of Medicine |
More Information
No publications provided
| Responsible Party: | Seung-Hwan Lee/Professor, Divison of cardiology, Department of internal medicine, Wonju Chrirstian Hospital |
| ClinicalTrials.gov Identifier: | NCT01347554 History of Changes |
| Other Study ID Numbers: | EVZT_1.0 |
| Study First Received: | April 27, 2011 |
| Last Updated: | July 12, 2011 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Yonsei University:
|
drug-eluting stent everolimus zotarolimus myocardial ischemia |
cardiovascular diseases MACE safety |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Everolimus Sirolimus |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 16, 2013