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Design and rationale of a randomized control trial testing the effectiveness of combined therapy with STAtin plus FENOfibrate and statin alone in non-diabetic, combined dyslipidemia patients with non-intervened intermediate coronary artery disease - STAFENO study

DC Field Value Language
dc.contributor.authorKwon, Taek-Geun-
dc.contributor.authorJang, Albert Y-
dc.contributor.authorKim, Sang Wook-
dc.contributor.authorHong, Young Joon-
dc.contributor.authorBae, Jang-Ho-
dc.contributor.authorLee, Sung Yun-
dc.contributor.authorKim, Sang-Hyun-
dc.contributor.authorHan, Seung Hyun-
dc.date.accessioned2020-09-02T05:14:16Z-
dc.date.available2020-09-02T14:15:55Z-
dc.date.issued2020-04-22-
dc.identifier.citationTrials. 2020 Apr 22;21(1):353ko_KR
dc.identifier.issn1745-6215-
dc.identifier.urihttps://hdl.handle.net/10371/168784-
dc.description.abstractBackground
Despite the chronicled success of low-density lipoprotein cholesterol (LDLc)-lowering statin therapy, substantial residual cardiovascular (CV) disease risk remains a problem worldwide, highlighting the need to for combination therapies targeting non-LDLc factors, such as with fenofibrate.

Methods/design
The STAFENO trial is a prospective, randomized, open-label, multi-center trial to compare the effect of statin plus fenofibrate with statin alone on the reduction and stabilization of plaque in non-diabetic, combined dyslipidemia patients with non-intervened, intermediate coronary artery disease (CAD) using virtual histology-intravascular ultrasound at 12 months. A total of 106 eligible patients are planned to be randomized to receive either a combination therapy (rosuvastatin 10 mg plus fenofibrate 160 mg/day) or monotherapy (rosuvastatin 10 mg/day) for 12 months. The primary endpoint of this study is the percentage change in the necrotic core volume. Secondary endpoints include changes in tissue characteristics and 1-year major CV events, including all-cause mortality, CV mortality, nonfatal myocardial infarction, stroke, and revascularization of the intervened and non-intervened lesions.

Discussion
The STAFENO trial will address whether combination treatment of statin and fenofibrate has an additive beneficial effect compared to statin alone on the reduction and stabilization of plaque and CV events in non-diabetic, combined dyslipidemia patients with non-intervened intermediate CAD.

Trial registration
ClinicalTrials.gov, NCT02232360. Registered 9 February 2014.

https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0004ULE&selectaction=Edit&uid=U00023SZ&ts=2&cx=juppd2
ko_KR
dc.description.sponsorshipThis is an investigator-initiated clinical trial with grant support from Daewoong Pharmaceutical Co. Ltd (Seoul, Korea). The sponsor has no role in the development of study protocols or study processes, including site selection, management, and data collection and analysis. The authors are solely responsible for the design and editing of this paper and its final content.ko_KR
dc.language.isoenko_KR
dc.publisherBMCko_KR
dc.titleDesign and rationale of a randomized control trial testing the effectiveness of combined therapy with STAtin plus FENOfibrate and statin alone in non-diabetic, combined dyslipidemia patients with non-intervened intermediate coronary artery disease - STAFENO studyko_KR
dc.typeArticleko_KR
dc.contributor.AlternativeAuthor권택근-
dc.contributor.AlternativeAuthor김상욱-
dc.contributor.AlternativeAuthor홍영준-
dc.contributor.AlternativeAuthor배장호-
dc.contributor.AlternativeAuthor이성윤-
dc.contributor.AlternativeAuthor김상현-
dc.contributor.AlternativeAuthor한승현-
dc.identifier.doidoi.org/10.1186/s13063-020-04291-5-
dc.citation.journaltitleTrialsko_KR
dc.language.rfc3066en-
dc.rights.holderThe Author(s)-
dc.date.updated2020-06-17T13:16:01Z-
dc.citation.number1ko_KR
dc.citation.startpage353ko_KR
dc.citation.volume21ko_KR
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