NCT05599061

Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Trial

Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Randomized Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Fundación EPIC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study aims to compare a preventive percutaneous coronary intervention (PCI) plus optimal medical treatment (OMT) strategy vs. OMT for treatment of non-functionally significant non-culprit lesions presenting with optical coherence tomography (OCT) findings indicative of vulnerable plaque, in patients with ST-elevation myocardial infarction (STEMI) and multivessel disease.

Detailed description

STEMI patients with multivessel disease planned for invasive evaluation of intermediate lesions (40-69% stenosis) are initially investigated with fractional flow reserve (FFR). Patients with FFR ≤ 0.80 are considered as screening failure and treated with PCI. Patients with FFR \> 0.80 are then investigated with optical coherence tomography (OCT). Patients without OCT findings of vulnerable plaque are treated with OMT and included in the OMT registry arm. Patients presenting with OCT characteristics of vulnerable plaque are included in the randomized trial comparing PCI with stent implantation plus OMT versus OMT.

Conditions

• Coronary Artery Disease
• Coronary Disease
• Ischemic Heart Disease

Interventions

Type	Name	Description
OTHER	FFR>0.80+ OCT with findings indicative of vulnerable plaque	Patients received OPTIMAL MEDICAL TREATMENT (OMT)+PCI
OTHER	FFR>0.80+ OCT with findings indicative of vulnerable plaque	OPTIMAL MEDICAL TREATMENT (OMT)

Timeline

• Start date: 2023-01-30
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2022-10-31
• Last updated: 2026-01-29

Locations

49 sites across 1 country: Spain