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

Fudan University

Status and phase: Completed; Phase 4

Conditions: ST Elevation Myocardial Infarction; Percutaneous Coronary Intervention

Treatments: Drug: Nicorandil; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04665648

ZS-CLEAN

Details and patient eligibility

About

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).

Enrollment: 1,500 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,500 participants in 2 patient groups, including a placebo group

Treatment arm

Experimental group

Description:

Patients who received intravenous nicorandil before and after reperfusion with primary percutaneous coronary intervention

Treatment:

Drug: Nicorandil

Placebo arm

Placebo Comparator group

Description:

Patients who received intravenous placebo before and after reperfusion with primary primary percutaneous coronary intervention

Treatment:

Drug: Placebo