Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
ZS-CLEAN
Description
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).
Trial arms
Trial start
2021-06-01
Estimated PCD
2024-08-30
Trial end
2024-12-31
Status
Recruiting
Phase
Early phase I
Treatment
Nicorandil
6 mg nicorandil iv. just before coronary intervention, 6mg/h ivgtt. up to 48h after coronary intervention
Arms:
Treatment arm
Other names:
intraveous nicorandil
Placebo
placebo iv. just before coronary intervention, ivgtt. up to 48h after coronary intervention
Arms:
Placebo arm
Other names:
intraveous palcebo
Size
1500
Primary endpoint
Major adverse cardiac events
12 month after primary PCI
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1500, 'type': 'ESTIMATED'}}
Updated at
2023-09-14

1 organization

1 product

1 drug

2 indications

Organization
Fudan University
Product
Nicorandil
Indication
ST Elevation Myocardial Infarction
Indication
Angioplasty
Drug
Varlilumab