CABG or PCI in Patients With Ischemic Cardiomyopathy (STICH)

June 20, 2024 updated by: Vastra Gotaland Region

CABG or PCI in Patients With Ischemic Cardiomyopathy - A Randomized Registry Clinical Trial

The STICH-SWEDEHEART trial will compare PCI vs CABG for revascularization of patients with HF and LV systolic dysfunction (LV ejection fraction (LVEF) <40%) and multi-vessel coronary artery disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Short background/ Rationale/Aim:

CABG has been shown to prolong survival in patients with reduced left ventricular (LV) function and multi-vessel coronary artery disease and "CABG is recommended as the first revascularization strategy choice in patients with multi-vessel disease and acceptable surgical risk". However, a major concern with CABG is the early risk of complications, including death and stroke. Although PCI has lower rates of peri-procedural complications than CABG in patients without heart failure (HF), this has not been confirmed in patients with HF. The lack of contemporary data comparing CABG and PCI in HF leaves clinicians with no guidance as to which option to choose, and a robust trial is therefore necessary. The STICH-SWEDEHEART trial will compare PCI vs CABG for revascularization of patients with HF and LV systolic dysfunction (LV ejection fraction (LVEF) < 40%) and multi-vessel coronary artery disease.

Study objective:

To test whether PCI is non-inferior to CABG for revascularization of patients with ischemic heart failure.

Study design:

Multicentre, open-label, randomized controlled trial

Study population:

Patients with ischemic cardiomyopathy and reduced ejection fraction.

Number of subjects:

470 subjects

Investigational treatment:

PCI

Treatment in control group:

CABG

Study endpoints:

Primary endpoint (variable):

The occurrence of the composite of death, stroke, non-procedural myocardial infarction or heart failure hospitalization at 3 years.

Key secondary endpoint The hierarchical occurrence (in descending order of importance) at 3-year follow-up of time to death, time to stroke, time to non-procedural myocardial infarction, number of heart failure hospitalizations and 1-year Kansas City Cardiomyopathy Questionnaire (KCCQ) score; evaluated using the win ratio approach.

Secondary safety endpoints

In-hospital occurrence of the following:

  1. Death
  2. Stroke
  3. Non-procedural myocardial infarction

  4. The occurrence of in-hospital BARC ≥3 bleeding

    Time to the occurrence of the following:

  5. Mediastinitis
  6. Pericardial tamponade Other secondary endpoints

1. Time to the occurrence of the following: A. Death, stroke or non-procedural myocardial infarction B. Death or heart failure hospitalization C. Heart failure hospitalization D. Coronary revascularization E. Death or myocardial infarction F. Death or stroke 2. Total number of days in-hospital during index hospitalization 3. Total number of days in intensive care unit during index hospitalization 4. Quality of life at 30 days and 365 days.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
470

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Elmir Omerovic, MD, PhD
  • Phone Number: +46 31 3421000
  • Email: elmir@wlab.gu.se

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years.
  2. Symptomatic HF defined as NYHA HF class II-IV within 1 month of enrolment
  3. LVEF ≤ 40% quantified by either echocardiography or gated SPECT ventriculography, or magnetic resonance (MR) or any other recognized assessment of LVEF
  4. Meaningful amount of myocardium at risk because of CAD (BCIS myocardial jeopardy score ≥ 6 on a recent (> 6 months) coronary angiogram);
  5. Heart team believes that a meaningful revascularization can be achieved by both PCI or CABG, with complete revascularization defined as residual ischemia in <10% of the left ventricle
  6. Heart team agrees that guideline directed medical therapy (GDMT) has been initiated for ≥1 month in prevalent and newly diagnosed cases. In patients hospitalized with newly diagnosed iLVSD (with or without acute coronary syndrome (ACS)) requiring revascularization before discharge, GDMT needs to be initiated, when possible, in-hospital before randomization, with the expectation that it will be titrated to maximally tolerated doses after revascularization
  7. Written informed consent obtained

Exclusion Criteria:

  1. Previous randomization in the study
  2. Decompensated heart failure requiring inotropic /adrenergic support, invasive or non-invasive ventilation or intra-aortic balloon pump/ventricular assist device therapy less than 48 hours prior to randomization
  3. Recent (<1 month) type 1 myocardial infarction
  4. Recent PCI (<3 months)
  5. Valvular heart disease or any other cardiac conditions (e.g. LV aneurysm) requiring surgical repair/replacement
  6. Prohibitive bleeding risk or clinical scenario mandating avoidance of long-term dual antiplatelet therapy
  7. Expected survival less than 3 years due to non-cardiac illness
  8. Circumstances likely to lead to poor treatment compliance
  9. Individuals for whom record in public health databases is not accessible (non-eligibility to public health system, parallel healthcare systems
  10. Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Percutaneous Coronary Intervention (PCI)
Patients will be revascularized by PCI
Procedure: Percutaneous Coronary Intervention (PCI)
Alternative treatment
No Intervention: Coronary artery bypass grafting (CABG)
Patients will be revascularized by CABG

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Major adverse cardiac event
Time Frame: 3 years
The occurrence of the composite of death, stroke, non-procedural myocardial infarction or heart failure hospitalization
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The occurrence of death
Time Frame: 3 years
Time to death
3 years
The occurrence of stroke
Time Frame: 3 year
Time to stroke
3 year
The occurrence of non-procedural myocardial infarction,
Time Frame: 3 year
Time to non-procedural myocardial infarction,
3 year
The occurrence of heart failure hospitalizations
Time Frame: 3 year
Number of heart failure hospitalizations
3 year
Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Time Frame: 1 year
Kansas City Cardiomyopathy Questionnaire score; evaluated using the win ratio approach. High score mean a better outcome
1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vastra Gotaland Region

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Karolinska University Hospital
University Hospital, Umeå
Region Örebro County

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2052

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EPM dnr 2021-04972

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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