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A 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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Jul 2026 → May 2027
See other at-risk trials from Korea University Anam Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jul 2026 to May 2027v7 Show 4 more changesShow less
    • Study completion pushed from Dec 2026 to May 2028
    • Enrollment target: 460 to 458
    • Eligibility criteria expanded, about 9 words
    • Collaborators expanded, about 10 words
  2. Primary completion date: Jul 2024 to Jul 2026
    • Study completion date: Dec 2024 to Dec 2026
    v6
  3. Interventions: Nicorandil (Drug), Placebo (Other) to Nicorandil (Drug)v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 7, 2022 to Dec 14, 2022
    • Site details revised
    v4
  5. Start date: Sep 1, 2022 to Oct 7, 2022v3
  6. Start date: Jul 1, 2022 to Sep 1, 2022v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05427786
Lead Sponsor Korea University Anam Hospital
Collaborators: Hanyang University Seoul Hospital, InjeUniversityIlsanPaikHospital, Ajou University School of Medicine
Conditions
(from sponsor)		 No-Reflow Phenomenon, Coronary Artery Disease, Percutaneous Coronary Intervention
Related terms Coronary Artery Disease, No-Reflow Phenomenon
Enrollment 458 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov