IHDNCT05534698
Coronary Artery Bypass Grafts or Percutaneous Coronary Intervention for High Risk Patients
A study testing PCI and CABG in people with IHD and LV Dysfunction, run by Danish Study Group at 1 site in Denmark.
Trial summary
Most patients with Left Ventricular Systolic Dysfunction (LVSD) or heart failure (HF) have coronary artery disease (CAD) while some patients also have renal disease. Life-saving revascularization is underperformed in patients with LVSD or HF due to CAD, and especially if there is concomitant renal disease. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- IHD, LV Dysfunction
- What is being tested?
- PCI and CABG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,550 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2022to Feb 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- LVEF<45% with or without HF medication
- Heart team believes that a meaningful revascularization can be achieve both by PCI and by CABG
- Patients with severe CAD, where guidelines suggest equipoise between PCI and CABG
Who cannot join
- Decompensated HF 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
- Recent (< 1 month) ST-elevation myocardial infarction
- Recent (< 1 month) type 2 myocardial infarction ▪ Valvular heart disease or any other cardiac conditions (for example, left ventricular aneurysm) indicating the need for surgical repair/replacement
- Prohibitive bleeding risk or clinical scenario mandating avoidance of long-term dual antiplatelet therapy
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Rigshospitalet, University of Copenhagen
Copenhagen, 2100
Lars Køber, MD, D.Sci, 35 45 33 76, LK@HEART.DK
About this study
Official title: Coronary Artery Bypass Grafts or Percutaneous Coronary Intervention for Revascularization in Moderate to Highs Risk Patients With Ischemic Heart Disease and Reduced Left Ventricular Ejection Fraction
Most patients with Left Ventricular Systolic Dysfunction (LVSD) or heart failure (HF) have coronary artery disease (CAD) while some patients also have renal disease. Life-saving revascularization is underperformed in patients with LVSD or HF due to CAD, and especially if there is concomitant renal disease. We hypothesize that PCI will be non-inferior to CABG for all-cause mortality and recurrent myocardial infarction (MI), stroke or hospitalization for HF. To compare revascularization by PCI versus by CABG, we will perform a multicentre, open-label, parallel, randomized, controlled trial in patients with severe CAD who belong to defined categories of moderate-to-high risk characteristics, where guidelines acknowledge that both PCI and CABG are relevant treatment options.
Read the detailed description
The STICH trial demonstrated a reduction in overall mortality after 10 years, but the 5-year analyses did not show significant benefits of CABG versus medical therapy. The extension of the STICH study, the STICHES study established the superiority of CABG over medical therapy for all-cause mortality (58.9% versus 66.1%; HR 0.84, 95%CI: 0.73-0.97; p = 0.02) over 9.8 years. Thus, these studies suggest that to offset the early operative risks of CABG, 10-year survival is needed. As many patients with HF and/or LVSD are elderly, both clinicians and patients are often unwilling to accept increased short-term risk even if they might eventually achieve long-term benefit, and thus not favour CABG. The available evidence suggest that PCI is feasible for patients with ischemic LVSD, and that PCI may yield long-term mortality rates like CABG with lower short-term morbidity The planned trial is a multicentre, open-label, parallel, randomized, controlled trial comparing revascularization by CABG versus by PCI in patients with severe CAD and at high risk, where guidelines accept both CABG and PCI as suitableand mortality. High risk is defined as patients with LVEF <45%, (irrespectively of clinical HF and severe renal disease), left anterior descending (LAD) disease in one- or two vessel disease, three-vessel disease with a SYNTAX score of up to 22 and left main disease with a SYNTAX score of up to 32.
The trial is powered for non-inferiorty.
- Conditions
- IHD, LV Dysfunction
- Being tested
- PCI, CABG
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIProcedure or surgery
Revascularization by PCI
CABGProcedure or surgery
Revascularization by CABG
| Study group | Role | What they receive |
|---|---|---|
| PCI | Active comparator | Revascularization by PCI Receives: Procedure: PCI |
| CABG | Active comparator | Revascularization based on CABG. Receives: Procedure: CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality, stroke, MI and hospitalization for HF
time to event
Measured: up to 10 years with analysis after 5 years
Secondary outcomes (1)
Composite of occurrence of cardiovascular death or cardiovascular rehospitalization.
time to event
Measured: up to 10 years with analysis after 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionDec 2032 (estimated)
- Study completionFeb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IHDStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, open-label, parallel, randomized, controlled trial comparing revascularization by CABG versus by PCI in patients with severe CAD and at high risk
- Masking
- None (open label)
- Enrolment
- 1,550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Study Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Lars V Køber, MD, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534698
- Sponsor's protocol ID
- H-21000675
- Status last verified
- Sep 2022
- First submitted
- 6 Sep 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available in a RedCap database and will be shared with other researchers after final report.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Bypass Grafts or Percutaneous Coronary Intervention for Revascularization in Moderate to Highs Risk Patients With Ischemic Heart Disease and Reduced Left Ventricular Ejection Fraction
- ClinicalTrials.gov ID
- NCT05534698
- Acronym / sponsor ID
- H-21000675
- Conditions
- IHD, LV Dysfunction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,550 participants (estimated)
- Lead sponsor
- Danish Study GroupResearch network
- Study start
- Oct 2022 (estimated)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Feb 2033 (estimated)
- First posted
- 9 Sep 2022 (actual)
- 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.
Most patients with Left Ventricular Systolic Dysfunction (LVSD) or heart failure (HF) have coronary artery disease (CAD) while some patients also have renal disease. Life-saving revascularization is underperformed in patients with LVSD or HF due to CAD, and especially if there is concomitant renal disease. We hypothesize that PCI will be non-inferior to CABG for all-cause mortality and recurrent myocardial infarction (MI), stroke or hospitalization for HF. To compare revascularization by PCI versus by CABG, we will perform a multicentre, open-label, parallel, randomized, controlled trial in patients with severe CAD who belong to defined categories of moderate-to-high risk characteristics, where guidelines acknowledge that both PCI and CABG are relevant treatment options.
Detailed description
The STICH trial demonstrated a reduction in overall mortality after 10 years, but the 5-year analyses did not show significant benefits of CABG versus medical therapy. The extension of the STICH study, the STICHES study established the superiority of CABG over medical therapy for all-cause mortality (58.9% versus 66.1%; HR 0.84, 95%CI: 0.73-0.97; p = 0.02) over 9.8 years. Thus, these studies suggest that to offset the early operative risks of CABG, 10-year survival is needed. As many patients with HF and/or LVSD are elderly, both clinicians and patients are often unwilling to accept increased short-term risk even if they might eventually achieve long-term benefit, and thus not favour CABG. The available evidence suggest that PCI is feasible for patients with ischemic LVSD, and that PCI may yield long-term mortality rates like CABG with lower short-term morbidity The planned trial is a multicentre, open-label, parallel, randomized, controlled trial comparing revascularization by CABG versus by PCI in patients with severe CAD and at high risk, where guidelines accept both CABG and PCI as suitableand mortality. High risk is defined as patients with LVEF <45%, (irrespectively of clinical HF and severe renal disease), left anterior descending (LAD) disease in one- or two vessel disease, three-vessel disease with a SYNTAX score of up to 22 and left main disease with a SYNTAX score of up to 32.
The trial is powered for non-inferiorty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentre, open-label, parallel, randomized, controlled trial comparing revascularization by CABG versus by PCI in patients with severe CAD and at high risk
| Arm | Type | Receives |
|---|---|---|
| PCI | Active comparator | Procedure: PCIRevascularization by PCI |
| CABG | Active comparator | Procedure: CABGRevascularization based on CABG. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
Key exclusion criteria (5 listed)
- Decompensated HF 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
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 |
|---|---|---|
| PCIRevascularization by PCI | Procedure or surgery | PCI |
| CABGRevascularization by CABG | Procedure or surgery | CABG |
Primary outcome
Composite of all-cause mortality, stroke, MI and hospitalization for HF
Time frame: up to 10 years with analysis after 5 years
time to event
1 secondary outcome
Composite of occurrence of cardiovascular death or cardiovascular rehospitalization.
Time frame: up to 10 years with analysis after 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Individual participant dataSharing planned: Yes. Data are available in a RedCap database and will be shared with other researchers after final report.
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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.
Lars V Køber, MD study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI and CABG in people with IHD and LV Dysfunction, run by Danish Study Group at 1 site in Denmark.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lars V Køber, MD (31120540, lk@heart.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of all-cause mortality, stroke, MI and hospitalization for HF (time frame: up to 10 years with analysis after 5 years). 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 15 Sep 2022.