Evidence map›Paper›PMID 32321551›Full record

ArticleTrials2020

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.

Taek-Geun Kwon, Albert Youngwoo Jang, Sang Wook Kim, Young Joon Hong, Jang-Ho Bae, Sung Yun Lee, Sang-Hyun Kim, Seung Hwan Han

Registry-linked trialOpen access · goldFull text readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02232360. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02232360 phase4unknown status

The Comparative Analysis of the Effects on Plaque Volume and Tissue Characteristics Between Combined Therapy With STAatin Plus FENOfibrate and Statin Alone in Mild to Moderate, Non- Intervened Coronary Artery Stenosis (STAFENO Trial)

Ran2014Enrolled106Registered outcomes8Posted comparisons0ConditionsCoronary Artery DiseaseArmsRosuvastatin alone, Rosuvastatin and fenofibrate
Open the trial in the graph
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 1 country.

Taek-Geun KwonDivision of Cardiology, Department of Internal Medicine, College of Medicine, Konyang University Hospital, Daejeon, Republic of Korea.
Albert Youngwoo JangDivision of Cardiology, Department of Internal Medicine, Gachon University College of Medicine, Gil Hospital, Incheon, Republic of Korea.
Sang Wook KimDivision of Cardiology, Department of Internal Medicine, Cardiovascular-Arrhythmia Center, Chung-Ang University Hospital, Seoul, Republic of Korea.
Young Joon HongDivision of Cardiology, Department of Internal Medicine, Chonnam National University Hospital, Gwangju, Republic of Korea.
Jang-Ho BaeDivision of Cardiology, Department of Internal Medicine, College of Medicine, Konyang University Hospital, Daejeon, Republic of Korea.
Sung Yun LeeDivision of Cardiology, Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Republic of Korea.
Sang-Hyun KimDivision of Cardiology, Department of Internal Medicine, Cardiovascular Center, Seoul National University College of Medicine Boramae Medical Center, Seoul, Republic of Korea.
Seung Hwan HanDivision of Cardiology, Department of Internal Medicine, Gachon University College of Medicine, Gil Hospital, Incheon, Republic of Korea. shhan@gilhospital.com.
Deleted InstitutionKonyang University Hospital · KRChonnam National University Hospital · KRInje University Ilsan Paik Hospital · KRSeoul National University · KRSNUH SMG-SNU Boramae Medical Center · KR

Funding

Daewoong Pharmaceutical Company Daewoong 19-329
6 · The paper itself

Abstract

backgroundDespite 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/

designThe 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 registrationClinicalTrials.gov, NCT02232360. Registered 9 February 2014. https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0004ULE&selectaction=Edit&uid=U00023SZ&ts=2&cx=juppd2.

Indexed as

AdultAgedAged, 80 and overCoronary Artery DiseaseDrug Therapy, CombinationDyslipidemiasFemaleFenofibrateFollow-Up StudiesHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMiddle AgedMulticenter Studies as TopicPlaque, AtheroscleroticProspective StudiesFenofibrateHydroxymethylglutaryl-CoA Reductase InhibitorsRosuvastatin CalciumCombination therapyFenofibrateRandomized control trialResidual cardiovascular riskStatinVirtual histology intravascular ultrasound

Identifiers

PMID32321551
PMCPMC7178941
OpenAlexW3019468964

What OpenQuestion holds

Textfull text, public
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.