A Randomized, Open Label, Parallel-group Study to Evaluate the Impact of Pre-procedural Intracoronary Nicorandil Injection to PREVENT ReductioN of DecREased TIMI FLOW in Patients Who Undergoing Percutaneous Coronary Intervention for the Coronary Artery Disease
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The aim of this study was to determine the effect of intra-coronary administration of nicorandil on the prevention of lowering of coronary blood flow for high-risk plaque lesions defined as the high value of lipid core burden index in patients with coronary artery disease who require stent treatment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• Over 19 years old
• Patients who agree to the study plan and clinical follow-up plan, voluntarily decide to participate in this study, and consent in writing to the consent to use information
• Patients who underwent NIRS-IVUS guided coronary stent surgery for coronary artery disease
Locations
Other Locations
Republic of Korea
Korea University Anam Hospital
RECRUITING
Seoul
Time Frame
Start Date: 2022-12-14
Estimated Completion Date: 2026-12
Participants
Target number of participants: 460
Treatments
Experimental: Pre-PCI IC Nicorandil
If the lipid core burden index at the main lesion site on vascular ultrasound exceeds 353, randomization was performed.~Nicorandil group will be administrated 8cc or more of the prescribed drug (Nicroandil) according to randomization into the coronary artery before starting balloon therapy.
No_intervention: Standard PCI
If the lipid core burden index at the main lesion site on vascular ultrasound exceeds 353, randomization was performed.~Standard PCI group will be performed coronary intervention including starting balloon therapy without pre-administrated nicorandil.
Related Therapeutic Areas
Sponsors
Leads: Korea University Anam Hospital