Evidence map›Paper›PMID 27558002›Full record

Trial reportTrials2016

Evaluation of the vascular protective effects of new oral anticoagulants in high-risk patients with atrial fibrillation (PREFER-AF): study protocol for a randomized controlled trial.

Jin-Bae Kim, Hyun Jun Joung, Jung Myung Lee, Jong Shin Woo, Woo-Shik Kim, Kwon Sam Kim, Kyung Hye Lee, Weon Kim

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02544932 (Prospective Randomized Study for Evaluating Vascular Protective Effects of New Oral Anticoagulants in High Risk Patients With Atrial Fibrillation), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 21% 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.

NCT02544932 phase3unknown statusnot on this map

Prospective Randomized Study for Evaluating Vascular Protective Effects of New Oral Anticoagulants in High Risk Patients With Atrial Fibrillation

TypeinterventionalSponsorKyunghee University Medical CenterRan2015 to 2017Enrolled55ConditionsAtrial FibrillationArmsdabigatran, ribaroxaban, Warfarin
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Article
  6. Review
  7. 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 1 institution in 1 country.

Jin-Bae KimDivision of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul, Hoegi-dong 1, Dongdaemun-gu, Seoul, 130-701, Republic of Korea.
Hyun Jun JoungDivision of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul, Hoegi-dong 1, Dongdaemun-gu, Seoul, 130-701, Republic of Korea.
Jung Myung LeeDivision of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul, Hoegi-dong 1, Dongdaemun-gu, Seoul, 130-701, Republic of Korea.
Jong Shin WooDivision of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul, Hoegi-dong 1, Dongdaemun-gu, Seoul, 130-701, Republic of Korea.
Woo-Shik KimDivision of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul, Hoegi-dong 1, Dongdaemun-gu, Seoul, 130-701, Republic of Korea.
Kwon Sam KimDivision of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul, Hoegi-dong 1, Dongdaemun-gu, Seoul, 130-701, Republic of Korea.
Kyung Hye LeeDivision of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul, Hoegi-dong 1, Dongdaemun-gu, Seoul, 130-701, Republic of Korea.
Weon KimDivision of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul, Hoegi-dong 1, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. mylovekw@hanmail.net.
Kyung Hee University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAtrial fibrillation (AF) is known to be associated with several pathophysiological mechanisms including endothelial dysfunction of the heart and arterial vessels. Recent evidence suggests that new oral anticoagulant (NOAC) treatment may improve endothelial function and the inflammatory process involved in atherosclerosis in AF patients. This study is designed to determine the efficacy of NOAC therapy in the prevention of endothelial dysfunction and the progression of atherosclerosis of AF subjects. METHOD/

designAF patients with a CHA2DS2-VASc score >2 and no previous history of overt coronary disease, severe peripheral arterial disease (PAD) or major stroke will be registered and randomly assigned either to the NOAC group (dabigatran or rivaroxaban) or the warfarin group in this prospective, randomized, 2-year follow-up study. Reactive hyperemia peripheral arterial tonometry (RH-PAT) measurements reflecting endothelial function will be conducted using the Endo-PAT2000 device. Left and right carotid intima-media thickness (IMT) will be measured at baseline, 12 months, and 24 months. The primary endpoint is defined as change in Reactive Hyperemia Index (RHI) at 12 months. Secondary endpoints included changes in the right and left maximum IMT of the common carotid artery (CCA) and internal carotid artery (ICA), the mean IMT of the CCA and ICA at 24 months, and 24-month cardiovascular events including cardiac death, stroke, acute myocardial infarction (AMI), overall cause of death, withdrawal of drug, or bleeding events. DISCUSSION: This is the first study to evaluate the efficacy of NOAC therapy for the prevention of endothelial dysfunction and progression of atherosclerosis in AF subjects. These findings are expected to expand the knowledge of NOAC pleotropic action in AF patients.

trial registrationClinicalTrials.gov: NCT02544932 , registered on 7 September 2015.

Indexed as

Clinical ProtocolsAdministration, OralAdultAgedAged, 80 and overAnticoagulantsAtherosclerosisAtrial FibrillationHumansMiddle AgedProspective StudiesSample SizeAnticoagulantsAnticoagulantAtherosclerosisAtrial fibrillationEndothelium

Identifiers

PMID27558002
PMCPMC4997652
OpenAlexW2513597861

What OpenQuestion holds

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LicenceCC BY
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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.