Coronary Artery DiseaseSTICH-3NCT05761067
STICH-3.0 International Trial Consortium
A study testing Percutaneous Coronary Intervention (PCI) in people with Coronary Artery Disease and Heart Failure, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
The primary objective of the STICH 3.0 Study is to determine whether CABG is superior to PCI in terms of all-cause mortality at 5 years in patients with severe CAD and iLVSD. Individual patient data from similar national RCTs independently powered for different efficacy endpoints will be pooled, harmonized, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Heart Failure
- What is being tested?
- Percutaneous Coronary Intervention (PCI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,800 participants
- Where
- 1 siteSweden
- Study dates
- 14 Sep 2022to 14 Sep 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- LVEF ≤40%
- Extensive coronary artery disease (typically defined as a British Cardiovascular Intervention Society jeopardy score of ≥6, on a scale from 0 to 12, with higher scores indicating greater extent of disease).
Who cannot join
- 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;
- Valvular heart disease or any other cardiac conditions (e.g. LV aneurysm) indicating the need for surgical repair/replacement;
- Prohibitive bleeding risk or clinical scenario mandating avoidance of long-term dual antiplatelet therapy;
- Pregnancy;
- Circumstances likely to lead to poor treatment adherence;
- STEMI within 72 hours;
- PCI within 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Dep of Cardiology, Sahlgrenska University Hospital
Gothenburg, 41345
Björn Redfors, MD, PhD, Professor, +46313421000, bjorn.redfors@wlab.gu.se
Elmir Omerovic, MD, PhD, Professor, +463421000, elmir@wlab.gu.se
About this study
Official title: The CABG or PCI in Patients With Ischemic Cardiomyopathy (STICH) 3.0 International Trial Consortium
The primary objective of the STICH 3.0 Study is to determine whether CABG is superior to PCI in terms of all-cause mortality at 5 years in patients with severe CAD and iLVSD.
Individual patient data from similar national RCTs independently powered for different efficacy endpoints will be pooled, harmonized, and analyzed.
The primary endpoint is all-cause mortality.
Read the detailed description
- Study rationale The evidence from observational studies comparing long-term outcomes between percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), and medical therapy in patients with iLVSD is inconsistent and likely affected by selection bias, with lower risk patients being accepted for CABG than PCI. In a large observational study including 4,794 propensity-matched patients with a LVEF <35% and CAD involving either the left anterior descending artery or multiple vessels, PCI was associated with a significantly higher risk of long-term mortality and of major adverse cardiovascular events (MACE) compared with CABG, but the risk of stroke was lower with PCI. A network meta-analysis from 2020 comparing CABG, PCI, and medical therapy (23 studies, 23,633 patients) suggested that CABG was the preferred strategy, with a reduced risk of mortality, cardiac death, MI, and urgent repeat revascularization (RR) compared to both medical therapy and PCI. A population level cohort study from Sweden including 2,509 patients from 2000-2018 with a left ventricular ejection fraction <50% also reported a significantly lower risk of death with CABG vs. PCI (odds ratio 0.62; 95%CI 0.41-0.96, p= 0.03). There is currently a lack of evidence from randomized trials powered to compare all-cause mortality between contemporary state-of-the-art PCI vs. CABG in patients with multivessel CAD and iLVSD. Given the current clinical equipoise between both revascularization modalities in this high-risk population, a definitive answer is critically required to guide clinical practice. The International STICH 3.0 International Trial Consortium has been established to address this ongoing conundrum in the STICH 3.0 International Collaborative Study.
- Study objective The primary objective of the STICH 3.0 Study is to determine whether CABG is superior to PCI in terms of all-cause mortality at 7 years in patients with severe CAD and iLVSD.
- Study design The STICH 3.0 study is composed of several individual national trials that were all prospectively designed by a multi-national steering committee to be combined in an international prospective individual patient data meta-analysis powered to examine whether CABG compared to PCI reduces the risk of death in patients with iLVSD. Individual patient data from these national RCTs, which are independently powered for different composite efficacy endpoints, will be pooled to compare mortality risk with PCI vs. CABG in patients with iLVSD. Each national study will be powered for a specific primary composite endpoint and all will collect all-cause mortality as a secondary endpoint. Harmonizing the study design elements across the national trials will enable data pooling to compare both revascularization modalities in terms of mortality with enough power. Patients with similar inclusion and exclusion criteria across trials will be merged in a large dataset powered for the objective of the international STICH 3.0 study. 3.1 National RCTs involved in the STICH 3.0 study Sweden: The primary objective is to determine whether PCI is non-inferior to CABG for revascularization in 470 patients with ischemic heart failure and LVEF≤40 in terms of the composite of death, stroke, non-procedural myocardial infarction or heart failure hospitalization at 3 years. Canada: The primary objective is to determine whether CABG compared to PCI is superior in reducing all-cause death, stroke, spontaneous myocardial infarction (MI), urgent repeat revascularization (RR), or heart failure (HF) readmission over a median follow-up of 5 years in 754 patients with multivessel/LM CAD and iLVSD. Australia and New Zealand: The primary objective is to determine whether PCI is non-inferior in to CABG in terms of the number of days alive out of hospital (DAOH) over an average of 3 years in 192 patients with iLVSD (LVEF≤40%) and multi-vessel CAD who are eligible for revascularization. Denmark: The primary objective is to determine whether PCI is non-inferior to CABG for the composite of all-cause mortality, stroke, MI, or hospitalization for HF at 5 years in 1,550 patients with CAD and at least one of the following: 1) severe renal disease; 2) HF (irrespective of LVEF); 3) severe CAD (proximal LAD disease or 3-vessel disease or with a SYNTAX score <23; or LM disease with a SYNTAX score <33). Germany: The primary objective is to determine whether CABG is superior to PCI in 440 patients with relevant CAD and LVEF≤40% in terms of death or cardiovascular re-hospitalization at 5 years. UK: The primary objective is to determine whether CABG is superior to PCI in terms of all-cause mortality or cardiovascular hospitalisation at a median follow-up of 5 years in 630 patients with significant CAD and LVEF≤40%. USA: The primary objective is to compare the rates of mortality, stroke, non-procedural MI, or CV hospitalization in patients with CAD and LVEF≤40%. Netherlands: The primary objective is to determine whether CABG is superior to PCI in reducing the composite of all-cause mortality, stroke, non-procedural MI, cardiovascular hospitalization, and Days Alive and Out of the Hospital (composite endpoint tested in an hierarchical way - win-ratio) in 400 patients with CAD and LVEF≤40%. 3.2 Study endpoints and definitions The primary endpoint is all-cause mortality. Secondary endpoints that are collected in each national trial include: Death, stroke or non-procedural myocardial infarction; Death or heart failure hospitalization; Heart failure hospitalization; Coronary revascularization; Death or myocardial infarction; Death or stroke. In-hospital complications after index procedure will also be collected as safety events. The definitions used by each national study will be used for secondary endpoint analysis of the STICH 3.0 International Collaborative Study. 3.3 Study interventions All study participants will be treated with optimal medical therapy based on national contemporary clinical practice guidelines, and at the discretion of the Heart Teams, including the use of beta-blockers; ACEi, ARB, or ARNi; MRAs; ivabradine; diuretics; SGLT2i; and devices (ICD or CRT-D). Medical therapy for secondary prevention of CAD will also be individualized by Heart Teams (antiplatelet therapy, lipid-lowering agents, etc.). Complete revascularization is the goal for all study participants. Revascularization by PCI: For patients randomized to PCI, contemporary best practices will be encouraged, including the use of intracoronary physiology (FFR, iFR, dPR, or other technologies) and of intracoronary imaging (IVUS and/or OCTs). CTOs will be treated by dedicated operators. Staged procedures are allowed if necessary. Revascularization by CABG: For patients randomized to CABG, the choice of performing on-pump or off-pump surgery will be left at the discretion of the operator based on the local expertise. The left internal thoracic artery is the preferred graft for the LAD. Minimally invasive surgery is not allowed. The use of multi-arterial graft, intraoperative echocardiography, epiaortic ultrasound, and anesthetic technique will also be tailored to the patient and the center, with best contemporary practices encouraged.
- Participants Patients with multi-vessel disease for which revascularization is deemed appropriate and suitable with both PCI and CABG by the local heart team are eligible for randomization if they meet all the inclusion criteria, and no exclusion criteria.
- Data collection and pooling Baseline and procedural data as well as endpoints will be collected separately for each national trial. The different national case report forms will contain all key datapoints for the international prospective individual patient data meta-analysis. These key elements of the case report forms will include: age, LVEF, LVEF imaging modality, coronary anatomy, myocardial viability, sex, height, weight, race, ethnicity, co-morbidities, past medical history, ACS status, baseline medication, index procedural details and adverse events, and endpoints. Denominalized and cleaned databases will be transferred to the data coordinating center and merged for analyses.
- Statistical analyses The superiority of CABG over PCI will be evaluated using a Bayesian Poisson regression model to analyses time-to-event data with baseline hazards stratified by trial and a random slope to account for variation in treatment effect between trials, using non-informative priors. 6.1 Sample size This is a superiority analysis. Assuming low heterogeneity in the log rate ratio of all-cause death between national trials and a cumulative incidence of death of 50% at 7 years in the control group, the first analysis, conducted after after all randomized patients have reached at least 60 days of follow-up and the median follow-up across all patients is at least 4 years, will have at least 80% power to detect a rate ratio of 0.85 in favour of CABG if 2,000 patients can be analysed, and at least 90% power to detect a rate ratio of 0.85 if at least 2800 patients can be analysed.
- Study organization The executive committee of the international prospective individual patient data meta-analysis will include principal investigators of each participating national RCT and 2 methodologists from the CTSU at the University of Oxford, and will be responsible for the operations of the analysis. The data coordinating center located at CTSU of the University of Oxford will be responsible for collecting, cleaning, and harmonizing the data from all national RCTs required for this study. The statistical analyses will be performed at CTSU of the University of Oxford.
- Ethics Participants of each national RCT will provide their informed consent for their data to be included in the analysis described in this protocol at the time of providing their consent to the trial. Data will be handled in compliance with the national regulations in place, including the the EU General Data Protection Regulation where applicable. The content of the informed consent form complies with relevant integrity and data protection legislation. In the subject information and the informed consent form, the subject will be given complete information about how collection, use and publication of their study data will take place. The subject information and the informed consent form will explain how study data are stored to maintain confidentiality in accordance with national data legislation. All information processed by the sponsor will be pseudonymized and identified with study code. National patient information leaflets and consent forms will contain clear wording that allows pseudo-anonymised data to leave each country and to be received by the University of Oxford. The informed consent form will also explain that for verification of the data, authorized representatives of the sponsor, as well as relevant authority, may require access to parts of medical records or study records that are relevant to the study, including the subject's medical history.
- Publication policy The individual national trials will all be registered at clinicaltrials.gov. before recruitment of their first subject. A detailed study protocol will be published before start of the pooled analysis in a peer reviewed. The Principal Investigator will co-ordinate dissemination of data for this study. Authorship will be determined according to the degree of engagement in the study as decided by the steering committee. A detailed separate publication plan shall be prepared by the steering committee for all secondary papers.
- Conditions
- Coronary Artery Disease, Heart Failure
- Being tested
- Percutaneous Coronary Intervention (PCI)
- Keywords
- PCI, CABG
- Medical subject headings
- Coronary Artery Disease, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary Intervention (PCI)Procedure or surgery
Alternative treatment
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Coronary Intervention (PCI) | Experimental | Patients will be revascularized by PCI Receives: Procedure: Percutaneous Coronary Intervention (PCI) |
| Coronary artery bypass grafting (CABG) | No intervention | Patients will be revascularized by CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All-cause mortality
Measured: 7 year
Secondary outcomes (5)
The occurrence of death
Time to death
Measured: 7 Year
The occurrence of stroke
Time to stroke
Measured: 7 year
The occurrence of non-procedural myocardial infarction
Time to non-procedural myocardial infarction
Measured: 7 year
The occurrence of failure hospitalization
Number of failure hospitalization
Measured: 7 year
The occurrence of coronary revascularization
Number of coronary revascularization
Measured: 7 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
14 Sep 202214 Sep 2029
- First posted9 Mar 2023
- Study start14 Sep 2022
- Primary completion14 Sep 2029 (estimated)
- Study completion14 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- A prospective individual patient meta-analysis of open-label, multicentre randomized trials.
- Masking
- None (open label)
- Enrolment
- 2,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- University of Glasgow, Yale University, University of Oxford, University of Leicester, University of Toronto, Université de Montréal, Curtin University, Monash University, Jena University Hospital, Hannover Medical School, University of Groningen, University of Copenhagen, Weill Medical College of Cornell University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761067
- Sponsor's protocol ID
- STICH-3 version 1.0
- Acronym
- STICH-3
- Status last verified
- Jun 2024
- First submitted
- 23 Jan 2023
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CABG or PCI in Patients With Ischemic Cardiomyopathy (STICH) 3.0 International Trial Consortium
- ClinicalTrials.gov ID
- NCT05761067
- Acronym / sponsor ID
- STICH-3 / STICH-3 version 1.0
- Conditions
- Coronary Artery Disease, Heart Failure
- Keywords
- PCI, CABG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- University of Glasgow, Yale University, University of Oxford, University of Leicester, University of Toronto, Université de Montréal, Curtin University, Monash University, Jena University Hospital, Hannover Medical School, University of Groningen, University of Copenhagen, Weill Medical College of Cornell University
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 14 Sep 2029 (estimated)
- Study completion
- 14 Sep 2029 (estimated)
- First posted
- 9 Mar 2023 (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.
The primary objective of the STICH 3.0 Study is to determine whether CABG is superior to PCI in terms of all-cause mortality at 5 years in patients with severe CAD and iLVSD.
Individual patient data from similar national RCTs independently powered for different efficacy endpoints will be pooled, harmonized, and analyzed.
The primary endpoint is all-cause mortality.
Detailed description
- Study rationale The evidence from observational studies comparing long-term outcomes between percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), and medical therapy in patients with iLVSD is inconsistent and likely affected by selection bias, with lower risk patients being accepted for CABG than PCI. In a large observational study including 4,794 propensity-matched patients with a LVEF <35% and CAD involving either the left anterior descending artery or multiple vessels, PCI was associated with a significantly higher risk of long-term mortality and of major adverse cardiovascular events (MACE) compared with CABG, but the risk of stroke was lower with PCI. A network meta-analysis from 2020 comparing CABG, PCI, and medical therapy (23 studies, 23,633 patients) suggested that CABG was the preferred strategy, with a reduced risk of mortality, cardiac death, MI, and urgent repeat revascularization (RR) compared to both medical therapy and PCI. A population level cohort study from Sweden including 2,509 patients from 2000-2018 with a left ventricular ejection fraction <50% also reported a significantly lower risk of death with CABG vs. PCI (odds ratio 0.62; 95%CI 0.41-0.96, p= 0.03). There is currently a lack of evidence from randomized trials powered to compare all-cause mortality between contemporary state-of-the-art PCI vs. CABG in patients with multivessel CAD and iLVSD. Given the current clinical equipoise between both revascularization modalities in this high-risk population, a definitive answer is critically required to guide clinical practice. The International STICH 3.0 International Trial Consortium has been established to address this ongoing conundrum in the STICH 3.0 International Collaborative Study.
- Study objective The primary objective of the STICH 3.0 Study is to determine whether CABG is superior to PCI in terms of all-cause mortality at 7 years in patients with severe CAD and iLVSD.
- Study design The STICH 3.0 study is composed of several individual national trials that were all prospectively designed by a multi-national steering committee to be combined in an international prospective individual patient data meta-analysis powered to examine whether CABG compared to PCI reduces the risk of death in patients with iLVSD. Individual patient data from these national RCTs, which are independently powered for different composite efficacy endpoints, will be pooled to compare mortality risk with PCI vs. CABG in patients with iLVSD. Each national study will be powered for a specific primary composite endpoint and all will collect all-cause mortality as a secondary endpoint. Harmonizing the study design elements across the national trials will enable data pooling to compare both revascularization modalities in terms of mortality with enough power. Patients with similar inclusion and exclusion criteria across trials will be merged in a large dataset powered for the objective of the international STICH 3.0 study. 3.1 National RCTs involved in the STICH 3.0 study Sweden: The primary objective is to determine whether PCI is non-inferior to CABG for revascularization in 470 patients with ischemic heart failure and LVEF≤40 in terms of the composite of death, stroke, non-procedural myocardial infarction or heart failure hospitalization at 3 years. Canada: The primary objective is to determine whether CABG compared to PCI is superior in reducing all-cause death, stroke, spontaneous myocardial infarction (MI), urgent repeat revascularization (RR), or heart failure (HF) readmission over a median follow-up of 5 years in 754 patients with multivessel/LM CAD and iLVSD. Australia and New Zealand: The primary objective is to determine whether PCI is non-inferior in to CABG in terms of the number of days alive out of hospital (DAOH) over an average of 3 years in 192 patients with iLVSD (LVEF≤40%) and multi-vessel CAD who are eligible for revascularization. Denmark: The primary objective is to determine whether PCI is non-inferior to CABG for the composite of all-cause mortality, stroke, MI, or hospitalization for HF at 5 years in 1,550 patients with CAD and at least one of the following: 1) severe renal disease; 2) HF (irrespective of LVEF); 3) severe CAD (proximal LAD disease or 3-vessel disease or with a SYNTAX score <23; or LM disease with a SYNTAX score <33). Germany: The primary objective is to determine whether CABG is superior to PCI in 440 patients with relevant CAD and LVEF≤40% in terms of death or cardiovascular re-hospitalization at 5 years. UK: The primary objective is to determine whether CABG is superior to PCI in terms of all-cause mortality or cardiovascular hospitalisation at a median follow-up of 5 years in 630 patients with significant CAD and LVEF≤40%. USA: The primary objective is to compare the rates of mortality, stroke, non-procedural MI, or CV hospitalization in patients with CAD and LVEF≤40%. Netherlands: The primary objective is to determine whether CABG is superior to PCI in reducing the composite of all-cause mortality, stroke, non-procedural MI, cardiovascular hospitalization, and Days Alive and Out of the Hospital (composite endpoint tested in an hierarchical way - win-ratio) in 400 patients with CAD and LVEF≤40%. 3.2 Study endpoints and definitions The primary endpoint is all-cause mortality. Secondary endpoints that are collected in each national trial include: Death, stroke or non-procedural myocardial infarction; Death or heart failure hospitalization; Heart failure hospitalization; Coronary revascularization; Death or myocardial infarction; Death or stroke. In-hospital complications after index procedure will also be collected as safety events. The definitions used by each national study will be used for secondary endpoint analysis of the STICH 3.0 International Collaborative Study. 3.3 Study interventions All study participants will be treated with optimal medical therapy based on national contemporary clinical practice guidelines, and at the discretion of the Heart Teams, including the use of beta-blockers; ACEi, ARB, or ARNi; MRAs; ivabradine; diuretics; SGLT2i; and devices (ICD or CRT-D). Medical therapy for secondary prevention of CAD will also be individualized by Heart Teams (antiplatelet therapy, lipid-lowering agents, etc.). Complete revascularization is the goal for all study participants. Revascularization by PCI: For patients randomized to PCI, contemporary best practices will be encouraged, including the use of intracoronary physiology (FFR, iFR, dPR, or other technologies) and of intracoronary imaging (IVUS and/or OCTs). CTOs will be treated by dedicated operators. Staged procedures are allowed if necessary. Revascularization by CABG: For patients randomized to CABG, the choice of performing on-pump or off-pump surgery will be left at the discretion of the operator based on the local expertise. The left internal thoracic artery is the preferred graft for the LAD. Minimally invasive surgery is not allowed. The use of multi-arterial graft, intraoperative echocardiography, epiaortic ultrasound, and anesthetic technique will also be tailored to the patient and the center, with best contemporary practices encouraged.
- Participants Patients with multi-vessel disease for which revascularization is deemed appropriate and suitable with both PCI and CABG by the local heart team are eligible for randomization if they meet all the inclusion criteria, and no exclusion criteria.
- Data collection and pooling Baseline and procedural data as well as endpoints will be collected separately for each national trial. The different national case report forms will contain all key datapoints for the international prospective individual patient data meta-analysis. These key elements of the case report forms will include: age, LVEF, LVEF imaging modality, coronary anatomy, myocardial viability, sex, height, weight, race, ethnicity, co-morbidities, past medical history, ACS status, baseline medication, index procedural details and adverse events, and endpoints. Denominalized and cleaned databases will be transferred to the data coordinating center and merged for analyses.
- Statistical analyses The superiority of CABG over PCI will be evaluated using a Bayesian Poisson regression model to analyses time-to-event data with baseline hazards stratified by trial and a random slope to account for variation in treatment effect between trials, using non-informative priors. 6.1 Sample size This is a superiority analysis. Assuming low heterogeneity in the log rate ratio of all-cause death between national trials and a cumulative incidence of death of 50% at 7 years in the control group, the first analysis, conducted after after all randomized patients have reached at least 60 days of follow-up and the median follow-up across all patients is at least 4 years, will have at least 80% power to detect a rate ratio of 0.85 in favour of CABG if 2,000 patients can be analysed, and at least 90% power to detect a rate ratio of 0.85 if at least 2800 patients can be analysed.
- Study organization The executive committee of the international prospective individual patient data meta-analysis will include principal investigators of each participating national RCT and 2 methodologists from the CTSU at the University of Oxford, and will be responsible for the operations of the analysis. The data coordinating center located at CTSU of the University of Oxford will be responsible for collecting, cleaning, and harmonizing the data from all national RCTs required for this study. The statistical analyses will be performed at CTSU of the University of Oxford.
- Ethics Participants of each national RCT will provide their informed consent for their data to be included in the analysis described in this protocol at the time of providing their consent to the trial. Data will be handled in compliance with the national regulations in place, including the the EU General Data Protection Regulation where applicable. The content of the informed consent form complies with relevant integrity and data protection legislation. In the subject information and the informed consent form, the subject will be given complete information about how collection, use and publication of their study data will take place. The subject information and the informed consent form will explain how study data are stored to maintain confidentiality in accordance with national data legislation. All information processed by the sponsor will be pseudonymized and identified with study code. National patient information leaflets and consent forms will contain clear wording that allows pseudo-anonymised data to leave each country and to be received by the University of Oxford. The informed consent form will also explain that for verification of the data, authorized representatives of the sponsor, as well as relevant authority, may require access to parts of medical records or study records that are relevant to the study, including the subject's medical history.
- Publication policy The individual national trials will all be registered at clinicaltrials.gov. before recruitment of their first subject. A detailed study protocol will be published before start of the pooled analysis in a peer reviewed. The Principal Investigator will co-ordinate dissemination of data for this study. Authorship will be determined according to the degree of engagement in the study as decided by the steering committee. A detailed separate publication plan shall be prepared by the steering committee for all secondary papers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective individual patient meta-analysis of open-label, multicentre randomized trials.
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Coronary Intervention (PCI) | Experimental | Procedure: Percutaneous Coronary Intervention (PCI)Patients will be revascularized by PCI |
| Coronary artery bypass grafting (CABG) | No intervention | –Patients will be revascularized by CABG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- LVEF ≤40%
- Extensive coronary artery disease (typically defined as a British Cardiovascular Intervention Society jeopardy score of ≥6, on a scale from 0 to 12, with higher scores indicating greater extent of disease).
Key exclusion criteria (7 listed)
- 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;
- Valvular heart disease or any other cardiac conditions (e.g. LV aneurysm) indicating the need for surgical repair/replacement;
- Prohibitive bleeding risk or clinical scenario mandating avoidance of long-term dual antiplatelet therapy;
- Pregnancy;
- Circumstances likely to lead to poor treatment adherence;
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 |
|---|---|---|
| Percutaneous Coronary Intervention (PCI)Alternative treatment | Procedure or surgery | Percutaneous Coronary Intervention (PCI) |
Primary outcome
Mortality
Time frame: 7 year
All-cause mortality
5 secondary outcomes
The occurrence of death
Time frame: 7 Year
The occurrence of stroke
Time frame: 7 year
The occurrence of non-procedural myocardial infarction
Time frame: 7 year
The occurrence of failure hospitalization
Time frame: 7 year
The occurrence of coronary revascularization
Time frame: 7 year
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 25 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Coronary Intervention (PCI) in people with Coronary Artery Disease and Heart Failure, run by Vastra Gotaland Region at 1 site in Sweden.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 25 Sep 2024. 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 Sweden. 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 Björn Redfors, MD, PhD (+46 313421000, bjorn.redfors@wlab.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 7 year). 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 25 Sep 2024.