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Effects of Nicorandil on Microvascular Dysfunction in Patients With STEMI Undergoing Primary PCI

Study acronym: NORMAL
StatusNot Yet Recruiting
PhasePhase 4
Started2026-03-01
View on ClinicalTrials.gov ↗

Amendment history

2026-03-11
minor
Study Status, References v2
Primary completion date2025-12→2026-12-01
Completion date2025-12→2027-12-31
Start date2025-08-01→2026-03-01
Publicationsdetails revised at 3 of 3 entries
2025-07-24
minor
Study Identification, Study Status v1
Start date2025-02-01→2025-08-01
Study titlerevised
Effects of Nicorandil on Microvascular Dysfunction in Patients withWith STEMI Undergoing Primary PCI
2025-01-15
minor
Original filing
Despite the success of restoration of epicardial blood flow by the primary percutaneous coronary intervention (PPCI), approximately one half of patients with ST-segment elevation myocardial infarction (STEMI) have failed myocardial reperfusion, namely microvascular dysfunction. Previous studies have shown that coronary microvascular damage significantly impacts the prognosis of patients with STEMI. Therefore, restoration of microvascular function is quite important during the PPCI procedures. Recent clinical trials found that nicorandil, a hybrid ATP-sensitive potassium channel opening agent, improved microvascular function, prevented no-reflow phenomenon, and had beneficial cardioprotective effects in patients receiving PPCI. However, there was a lack of evidence on the protective effects of nicorandil on microvascular function. The coronary angiography-derived IMR (AMR) is a novel wire-free technology developed for fast computation of IMR in patients undergoing coronary angiography, thereby enabling the quantification of coronary microcirculation of patients. This study is aimed to investigate the effects of nicorandil on microvascular dysfunction as evaluated by AMR in patients with STEMI.
Trial Details
NCT Number NCT06787430
Lead Sponsor China National Center for Cardiovascular Diseases
Conditions STEMI - ST-segment Elevation Myocardial Infarction
Enrollment 170 participants
Start Date 2026-03-01
Primary Completion 2026-12-01 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-12