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MULTivessel Immediate Versus STAged RevaScularization in Acute Myocardial Infarction -The MULTISTARS AMI Trial (MULTISTARS AMI)

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ClinicalTrials.gov Identifier: NCT03135275
Recruitment Status : Recruiting
First Posted : May 1, 2017
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
The primary objective of the trial is to compare, in patients presenting with ST segment elevation myocardial infarction (STEMI) and multi-vessel disease (MVD), the safety and efficacy of immediate complete revascularization of all significant coronary lesions versus culprit vessel only revascularization and staged percutaneous coronary intervention (PCI) of all significant coronary lesions (within 19 to 45 days), in a non-inferiority trial using a third generation, biodegradable-polymer, everolimus-eluting stent.

Condition or disease Intervention/treatment Phase
ST-elevation Myocardial Infarction Multivessel Coronary Disease Procedure: Staged complete PCI Procedure: Immediate complete PCI Device: Synergy™ stent Not Applicable

Detailed Description:

An investigator-initiated, randomized, multicenter, two-arm, open-label study of consecutive patients presenting with STEMI and MVD in stable hemodynamic conditions, undergoing after successful PCI of the culprit lesion either (1:1 randomization) immediate revascularization of all additional target lesions during the index procedure or staged PCI of all additional target lesions (within 19 to 45 days) using the Boston Scientific Synergy™ stent.

The goal of this trial is to compare two treatment strategies that are currently performed in clinical practice: immediate complete revascularization versus staged complete revascularization in patients with STEMI and MVD.

Patients randomized to immediate complete revascularization will have treated during the index procedure, after revascularization of the culprit lesion, all significant non-culprit coronary lesions.

Patients randomized to staged complete revascularization will have treated during the index procedure only the culprit lesion, and they will be hospitalized after 19-45 days for complete revascularization of all significant non-culprit coronary lesions.

For both groups, lesion are considered significant when causing a ≥70% diameter stenosis by visual estimation in at least two projections on the coronary angiogram.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MULTivessel Immediate Versus STAged RevaScularization in Acute Myocardial Infarction - The MULTISTARS AMI Trial
Actual Study Start Date : January 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: Staged complete PCI
Patients randomized to staged complete PCI will have treated during the index admission only the culprit lesion and they will be hospitalized after 19-45 days, to complete the coronary revascularization on the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.
Procedure: Staged complete PCI
During the index procedure, patients will have treated with primary PCI the culprit lesion only. Patients will be hospitalized again after 19-45 days to undergo PCI of ther other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.

Device: Synergy™ stent
Bioabsorbable Polymer Drug-Eluting Stent

Experimental: Immediate complete PCI
Patients randomized to immediate complete PCI will have treated immediately after the revascularization of the culprit lesion during the index procedure, the other significant coronary stenosis. All the revascularizations will be performed with Synergy™ stent.
Procedure: Immediate complete PCI
During the index procedure, patients will have treated with primary PCI the culprit lesion, as well as all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.

Device: Synergy™ stent
Bioabsorbable Polymer Drug-Eluting Stent




Primary Outcome Measures :
  1. The primary outcome measure is a composite of all-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, hospitalization for heart failure, and stroke at 1 year [ Time Frame: 1-year ]

Secondary Outcome Measures :
  1. all-cause death [ Time Frame: 1 year ]
  2. non-fatal myocardial infarction [ Time Frame: 1 year ]
  3. unplanned ischemia-driven revascularizations [ Time Frame: 1-year ]
  4. hospitalization for heart failure [ Time Frame: 1 year ]
  5. Stroke [ Time Frame: 1 year ]
  6. Cardiac death [ Time Frame: 1-year ]
  7. Cardiac death or myocardial infarction [ Time Frame: 1 year ]
  8. All-cause death or myocardial infarction [ Time Frame: 1 year ]
  9. Stent thrombosis [ Time Frame: 1 year ]
  10. Dialysis or acute renal insufficiency [ Time Frame: 1 year ]
  11. Bleeding event (BARC definition) [ Time Frame: 1 year ]
  12. non-cardiovascular death [ Time Frame: 1 year ]
  13. Cardiovascular death [ Time Frame: 1 year ]
  14. Procedural success [ Time Frame: 1 year ]
  15. Quality of life (EQ-5D questionnaire) [ Time Frame: 1 year ]
  16. Target Lesion Revascularization (TLR) [ Time Frame: 1 year ]
  17. Target Vessel Revascularization (TVR) [ Time Frame: 1 year ]
  18. composite of all-cause death, non-fatal MI, unplanned ischemia-driven revascularization, hospitalization for heart failure, and stroke [ Time Frame: 3 months ]
  19. composite of all-cause death, non-fatal MI, unplanned ischemia-driven revascularization, hospitalization for heart failure, and stroke [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Cost-effectiveness analysis [ Time Frame: 1 year ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age ≥ 18 years
  • Spontaneous acute STEMI (patients presenting within 24 hours of symptom onset)
  • Suitability for PCI from femoral or radial access
  • Coronary anatomy suitable for complete coronary revascularization with Synergy® stent implantation
  • Identifiable culprit lesion/artery
  • At least one non-culprit coronary stenosis ≥ 70% in at least two projections, in a vessel with a lumen diameter ≥2.25 - ≤5.75 mm, other than the culprit artery
  • TIMI Flow 3 or TIMI flow 2 after revascularization of the culprit artery
  • Stable hemodynamics at the end of the culprit vessel revascularization

Exclusion Criteria:

  • Inability to give informed consent
  • Cardiogenic shock
  • Prolonged resuscitation >10 min
  • General unsuitability for PCI
  • Need for emergency CABG
  • Previous CABG
  • Planned hybrid revascularization
  • Coronary artery dissection
  • Stent thrombosis
  • Instent restenosis
  • Previous documented allergic reaction to everolimus or to any stent material
  • Severe mechanical complication of acute myocardial infarction
  • Pre-existing severe renal failure (eGFR <30 mL/min) or dialysis
  • Chronic total occlusion of a major coronary artery
  • Left main stem stenosis ≥50% or left main stem equivalent (ostial left anterior descending and ostial circumflex stenosis ≥70%)
  • panned coronary, cerebrovascular, or peripheral arterial revascularization
  • Planned cardiac or major surgery
  • Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12 Inhibitor for at least 90 days, except for patients on oral anticoagulation
  • Known pregnancy at the time of inclusion
  • Participation in another clinical study with an investigational product
  • Life expectancy <1 year

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): NCT03135275


Contacts
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Contact: Barbara E. Stähli, MD, eMBA barbara.staehli@usz.ch
Contact: Willibald Maier, MD willibald.maier@usz.ch

Locations
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Switzerland
University Hospital Zürich, Cardiology Department Recruiting
Zurich, Switzerland, 8091
Contact: Barbara E Stähli, MD         
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Willibald Maier, MD
Principal Investigator: Barbara E. Stähli, MD, eMBA

Publications of Results:

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03135275     History of Changes
Other Study ID Numbers: MULTISTARS_USZ
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Zurich:
ST-elevation Myocardial Infarction
Multivessel coronary disease
Immediate complete coronary revascularization
Staged complete coronary revascularization
Percutaneous coronary intervention
Biodegradable-polymer everolimus-eluting stent
Additional relevant MeSH terms:
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Myocardial Infarction
Coronary Disease
Coronary Artery Disease
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases