Clinical Efficacy and SAfety of Intravenous Infusion of Nicorandil During Primary Percutaneous Coronary Intervention

Impact of Intravenous Administration of Nicorandil As Adjuncts to Reperfusion Treatment for Acute ST Segment Elevation Myocardial Infarction: a Multi-center Randomized Controlled Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04665648

Acronym

CLEAN

Enrollment

1500

Registered

2020-12-11

Start date

2021-06-01

Completion date

2024-12-31

Last updated

2025-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Percutaneous Coronary Intervention, ST Elevation Myocardial Infarction

Brief summary

The investigators evaluate the efficacy and safety of intravenous administration of nicorandil as adjuncts to reperfusion treatment in acute ST-segment elevation acute myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI).

Interventions

DRUGNicorandil

6 mg nicorandil iv. just before coronary intervention, 6mg/h ivgtt. up to 48h after coronary intervention

DRUGPlacebo

placebo iv. just before coronary intervention, ivgtt. up to 48h after coronary intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 18-80 years; * acute ST-segment elevation myocardial infarction within 12 hours of symptom onset;

Exclusion criteria

* systolic blood pressure\<100mmHg; * cardiac shock; * aortic dissection; * history of myocardial infarction or percutaneous coronary intervention or coronary artery bypass grafting (\<6 month); * history of the treatment of nicorandil (\<6 month); * history of intravenous nitrates before percutaneous coronary intervention; * contraindicated or intolerable to nicorandil; * pregnant or lactation period; * patients with an estimated survival time of less than 1 year.

Design outcomes

Primary

Measure	Time frame	Description
Major adverse cardiac events	12 month after primary PCI	cardiac death, myocardial reinfarction, target vessel revascularization, unplanned hospitalization for heart failure

Secondary

Measure	Time frame	Description
Rate of slow re-flow/no-reflow	3 minutes after primary PCI	final coronary flow in the culprit artery
Rate fo complete ST-segment resolution	2 hours after primary PCI	ST-segment resolution \>50% in ECG
Target vessel revascularization	12 months after primary PCI	Target vessel revascularization
Myocardial reinfarction	12 months after primary PCI	Myocardial reinfarction
Unplanned hospitalization for heart failure	12 months after primary PCI	Unplanned hospitalization for heart failure
Cardiac death	12 months after primary PCI	Cardiac death

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026