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OpenTrials
Completed

NCT Number: NCT04665648

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

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).

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Key information

Conditions

ST Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Percutaneous Coronary Intervention Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nicorandil

Drug

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

Other names: intraveous nicorandil

Placebo

Drug

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

Other names: intraveous palcebo

Primary outcomes

  1. Major adverse cardiac events

    Time frame: 12 month after primary PCI

    cardiac death, myocardial reinfarction, target vessel revascularization, unplanned hospitalization for heart failure

Secondary outcomes

  1. Rate of slow re-flow/no-reflow

    Time frame: 3 minutes after primary PCI

    final coronary flow in the culprit artery

  2. Rate fo complete ST-segment resolution

    Time frame: 2 hours after primary PCI

    ST-segment resolution >50% in ECG

  3. Cardiac death

    Time frame: 12 months after primary PCI

    Cardiac death

  4. Myocardial reinfarction

    Time frame: 12 months after primary PCI

    Myocardial reinfarction

  5. Target vessel revascularization

    Time frame: 12 months after primary PCI

    Target vessel revascularization

  6. Unplanned hospitalization for heart failure

    Time frame: 12 months after primary PCI

    Unplanned hospitalization for heart failure

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Acronym: CLEAN

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 11, 2020
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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