NCT05329285 CABG or PCI in Patients With Ischemic Cardiomyopathy
| NCT ID | NCT05329285 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vastra Gotaland Region |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 470 participants |
| Start Date | 2022-09-14 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 470 participants in total. It began in 2022-09-14 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05329285 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05329285 currently recruiting?
Yes, NCT05329285 is actively recruiting participants. Contact the research team at Bjoern.Redfors@wlab.gu.se for enrollment information.
Where is the NCT05329285 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT05329285 clinical trial?
NCT05329285 is sponsored by Vastra Gotaland Region. The trial plans to enroll 470 participants.