Evidence map›Paper›PMID 39539664›Full record

ArticleFrontiers in neurology2024

Optimal antithrombotic therapy in ischemic stroke patients with non-valvular atrial fibrillation and atherothrombosis: study protocol for a randomized controlled trial.

Shuhei Okazaki, Haruko Yamamoto, Koko Asakura, Katsuhiro Omae, Hirotada Maeda, Kanta Tanaka, Shiro Yamamoto, Teruyuki Hirano, Yasuyuki Iguchi, Manabu Sakaguchi and 6 more

Registry-linked trialAbstract read
In one paragraph

Article in Frontiers in neurology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03062319 (Optimal Antithrombotic Therapy in Ischemic Stroke Patients with Non-Valvular Atrial Fibrillation and Atherothrombosis), which is not on this 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
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.

NCT03062319 phase4terminatednot on this map

Optimal Antithrombotic Therapy in Ischemic Stroke Patients with Non-Valvular Atrial Fibrillation and Atherothrombosis

TypeinterventionalSponsorNational Hospital Organization Osaka National HospitalRan2017 to 2023Enrolled321ConditionsIschemic Stroke, Atrial Fibrillation, AtherothrombosisArmsOral Anticoagulant, Antiplatelet Drug
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
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

16 authors.

Shuhei OkazakiDepartment of Neurology, NHO Osaka National Hospital, Osaka, Japan.
Haruko YamamotoDepartment of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.
Koko AsakuraDepartment of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.
Katsuhiro OmaeDepartment of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.
Hirotada MaedaDepartment of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.
Kanta TanakaDepartment of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.
Shiro YamamotoDepartment of Neurology, NHO Osaka National Hospital, Osaka, Japan.
Teruyuki HiranoDepartment of Stroke and Cerebrovascular Medicine, Kyorin University School of Medicine, Tokyo, Japan.
Yasuyuki IguchiDepartment of Neurology, The Jikei University School of Medicine, Tokyo, Japan.
Manabu SakaguchiDepartment of Neurology, Osaka General Medical Center, Osaka, Japan.
Masatoshi KogaDepartment of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.
Masafumi IharaDepartment of Neurology, National Cerebral and Cardiovascular Center, Osaka, Japan.
Kazunori ToyodaDepartment of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.
Teruo NoguchiDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.
Nobuyuki SakaiDepartment of Neurosurgery, Seijinkai Shimizu Hospital, Kyoto, Japan.
Hiroshi YamagamiDepartment of Neurology, NHO Osaka National Hospital, Osaka, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The addition of antiplatelet therapy to anticoagulant therapy in patients with stroke with non-valvular atrial fibrillation (NVAF) and atherothrombotic disease may increase bleeding risk without reducing recurrent stroke risk. Aims: To evaluate the clinical benefits of anticoagulant monotherapy compared to combination therapy with anticoagulants and antiplatelet agents. Methods and design: This is an investigator-initiated prospective multicenter, randomized, open-label, parallel-group clinical trial. Patients with NVAF and atherothrombotic disease who have had a recent ischemic stroke or transient ischemic attack will be eligible to participate in this trial. Study outcomes: The primary outcome is a composite of ischemic cardiovascular events, including cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, ischemic events requiring urgent revascularization, and major bleeding events within 2 years after randomization. Sample size estimates: This study will enroll 400 patients, 200 receiving anticoagulant monotherapy and 200 receiving combination therapy. This sample size will provide 90% power (one-sided Discussion: This will be the first study to assess the net clinical benefit of oral anticoagulant monotherapy in ischemic stroke patients with NVAF and atherothrombosis. Clinical trial registration: https://clinicaltrials.gov/study/NCT03062319, NCT03062319; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000029222, UMIN000025392; https://jrct.niph.go.jp/latest-detail/jRCTs051180202, jRCTs051180202.

Indexed as

anticoagulantantiplateletatherothrombosisischemic strokenonvalvular atrial fibrillation (NVAF)randomized controlled trial

Identifiers

PMID39539664
PMCPMC11558694

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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.