Trial DesignsIntravenous nicorandil during primary percutaneous coronary intervention in patients with ST-Elevation myocardial infarction: Rationale and design of the Clinical Efficacy and Safety of Intravenous Nicorandil (CLEAN) trial
Section snippets
Trial Design
The CLEAN trial is an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of intravenous nicorandil as adjuncts to reperfusion therapy during primary PCI in patients with STEMI, which will recruit 1,500 patients in 40 sites across China. Recruitment was competitive with no maximum limit for patients from each center.
Eligibility
Male and female patients, aged ≥18 years and <80 years, with STEMI within 12 hours of symptom onset, were
Funding and Trial Oversight
This is an investigator-initiated study with financial support from the National Key Research and Development Program of China (grant number: 2016YFC1301203), funded by the Ministry of Science and Technology of the People's Republic of China. Sihuan Kebao Pharmaceutical (Beijing, China) provided the study drugs and placebos. The sponsor's role includes study design, overseeing, logistic support, and reviewing the reports of the study. The study protocol and other associated documents were
Ethics and Dissemination
The study fully adheres to the ethical principles of the Declaration of Helsinki, the specifications of the International Conference of Harmonization and Good Clinical Practice. The study protocol was approved by an independent ethics committee or institutional review board at each site.
Informed consent and detailed information about the study will be provided to all the patients before randomization. All the data in this trial are encrypted and stored in an online database accessible only to
Discussion
Nicorandil can not only effectively induce the dilatation of small vessels (<100 um) and increase coronary blood flow, but also prevents reperfusion injury and protects the heart against ischemic injury. Recent clinical trials have reported that nicorandil has beneficial effects as an adjunctive therapy for patients with ischemic heart disease, including microvascular angina and reperfusion-induced damage following coronary angioplasty. Kawai et al6 reported that the intravenous administration
Conclusion
CLEAN is a multicenter, randomized, double-blind, placebo-controlled trial comparing the intravenous administration of nicorandil and placebo as an adjunct to reperfusion therapy for acute STEMI. The trial is designed to provide a definitive report on the efficacy and safety of the intravenous infusion of nicorandil during PCI in patients with STEMI. The results of this trial will inform clinical practice and international guidelines.
Trial Status
Recruitment began in January 2021 and is estimated to complete in December 2023.
Funding
This study was supported by the National Key Research and Development Program of China (No. 2016YFC1301203), National Natural Science Foundation (No. 82170458) and Key Clinical Research Projects of National Clinical Research Center for Interventional Medicine (No. 2021-003).
Conflict of Interests
None reported.
Acknowledgments
The authors express their gratitude to all the clinical centers, hospitals and researchers participating in the CLEAN trial.
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Cited by (0)
Dong Huang and Hongxian Wu contributed equally to this work.