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

January 9, 2024 updated by: University of Zurich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

840

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital Zürich, Cardiology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
  • STEMI due to ST
  • 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 renal replacement therapy
  • 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%)
  • In-stent restenosis
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 all 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 all the 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 all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.
Device: Synergy™ stent
Bioabsorbable Polymer Drug-Eluting 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, hospitalization for heart failure, and stroke
Time Frame: 6 months
Primary endpoint
6 months
All-cause death
Time Frame: 6 months, 1 year
Single components of the primary endpoint
6 months, 1 year
Non-fatal myocardial infarction
Time Frame: 6 months, 1 year
Single components of the primary endpoint
6 months, 1 year
Unplanned ischemia-driven revascularization
Time Frame: 6 months, 1 year
Single components of the primary endpoint
6 months, 1 year
Hospitalization for heart failure
Time Frame: 6 months, 1 year
Single components of the primary endpoint
6 months, 1 year
Stroke
Time Frame: 6 months, 1 year
Single components of the primary endpoint
6 months, 1 year
Target lesion revascularization (TLR)
Time Frame: 6 months, 1 year
6 months, 1 year
Target vessel revascularization (TVR)
Time Frame: 6 months, 1 year
6 months, 1 year
Non-cardiovascular death
Time Frame: 6 months, 1 year
6 months, 1 year
Cardiac death
Time Frame: 6 months, 1 year
6 months, 1 year
Cardiovascular death
Time Frame: 6 months, 1 year
6 months, 1 year
Cardiac death or myocardial infarction
Time Frame: 6 months, 1 year
6 months, 1 year
All-cause death or myocardial infarction
Time Frame: 6 months, 1 year
6 months, 1 year
Stent thrombosis
Time Frame: 6 months, 1 year
6 months, 1 year
Acute renal insufficiency or dialysis
Time Frame: 6 months, 1 year
6 months, 1 year
Procedural success
Time Frame: 6 months, 1 year
6 months, 1 year
Bleeding event (BARC definition)
Time Frame: 6 months, 1 year
6 months, 1 year
Quality of life (EQ-5D questionnaire)
Time Frame: 6 months, 1 year
6 months, 1 year

Other Outcome Measures

Outcome Measure
Time Frame
Cost-effectiveness analysis
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Barbara E. Stähli, MD, eMBA, University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

May 1, 2017

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MULTISTARS_USZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ST-elevation Myocardial Infarction

Clinical Trials on Staged complete PCI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe