Evidence map›Paper›PMID 28765760›Full record

ArticleJournal of arrhythmia2017

Study design of GENERAL (general practitioners and embolism prevention in NVAF patients treated with rivaroxaban: Real-life evidence): A multicenter prospective cohort study in primary care physicians to investigate the effectiveness and safety of rivaroxaban in Japanese patients with NVAF.

Kengo Kusano, Masaharu Akao, Hikari Tsuji, Kunihiko Matsui, Shinya Hiramitsu, Yutaka Hatori, Hironori Odakura

Open access · goldAbstract read
In one paragraph

Article in Journal of arrhythmia, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 97% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Observational
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

7 authors at 4 institutions in 1 country.

Kengo KusanoDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Japan.
Masaharu AkaoDepartment of Cardiology, National Hospital Organization Kyoto Medical Center, Japan.
Hikari TsujiTsuji Clinic, Japan.
Kunihiko MatsuiKumamoto University Hospital, Japan.
Shinya HiramitsuHiramitsu Heart Clinic, Japan.
Yutaka HatoriHatori Clinic, Japan.
Hironori OdakuraDobashi Naika Clinic, Japan.
Kumamoto University Hospital · JPKyoto Medical Center · JPNational Cerebral and Cardiovascular Center · JPUji Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRivaroxaban, a direct oral anticoagulant (DOAC), has become available for stroke prevention in patients with non-valular atrial fibrillation (NVAF). However, little is known about its effectiveness and safety when prescribed by general practitioners in real-life settings.

methodsGENERAL is a multicenter, prospective, non-interventional observational study of patients receiving rivaroxaban for NVAF in daily clinical practice prescribed specifically by general practitioners. The target number of participating medical institutions is 500-700 clinics with fewer than 20 beds and the target number of participants is 5000. The baseline clinical data, including antidementia medication and frailty, and follow-up data including concomitant treatment and outcomes until September 2018 (maximum three years) will be collected. The primary efficacy endpoints will be stroke and/or systemic embolism and the secondary endpoints will be major bleeding meeting the ISTH guidelines, non-major and clinically relevant bleeding, onset of symptomatic stroke (ischemic/hemorrhagic), systemic embolism, deep vein thrombosis/pulmonary thromboembolism, myocardial infarction and/or cardiovascular death, and systemic embolism. Based on the provided information, the event assessment committee will investigate the endpoint-related events. The annual incidence and predictive factors for primary/secondary endpoint will be investigated based on underlying disease, age, renal function, and CHADS

resultsThe results of this study are currently under investigation.

conclusionThis study will provide important information regarding the effectiveness and safety of rivaroxaban treatment in Japanese patients with NVAF among general practitioners.

Indexed as

AnticoagulantsDOACGeneral practitionerNon-valvular atrial fibrillationStroke

Identifiers

PMID28765760
PMCPMC5529321
OpenAlexW2591625415

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.