Evidence map›Paper›PMID 36945020›Full record

ArticleTrials2023

Efficacy and safety of rivaroxaban plus clopidogrel versus aspirin plus clopidogrel in patients with coronary atherosclerotic heart disease and gastrointestinal disease undergoing percutaneous coronary intervention: study protocol for a non-inferiority randomized controlled trial.

Tienan Zhou, Yinghui Gong, Jingyuan Li, Yasong Wang, Xiaozeng Wang

Open access · goldFull text readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. 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
0.7field-weighted citation impact, top 29% 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. 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

5 authors at 1 institution in 1 country.

Tienan Zhou *Department of Cardiology, General Hospital of Northern Theater Command, No. 83 Wenhua Rd, Shenyang, 110016, Liaoning, China.
Yinghui Gong *Department of Cardiology, General Hospital of Northern Theater Command, No. 83 Wenhua Rd, Shenyang, 110016, Liaoning, China.
Jingyuan LiDepartment of Cardiology, General Hospital of Northern Theater Command, No. 83 Wenhua Rd, Shenyang, 110016, Liaoning, China.
Yasong WangDepartment of Cardiology, General Hospital of Northern Theater Command, No. 83 Wenhua Rd, Shenyang, 110016, Liaoning, China.
Xiaozeng WangDepartment of Cardiology, General Hospital of Northern Theater Command, No. 83 Wenhua Rd, Shenyang, 110016, Liaoning, China. wxiaozeng@163.com.ORCID http://orcid.org/0000-0003-1979-0287
General Hospital of Shenyang Military Region · CN

Funding

Natural Science Foundation of Liaoning Province 2021-MS-045
6 · The paper itself

Abstract

backgroundDual antiplatelet therapy (DAPT) with aspirin and a P2Y

methodThe study is a prospective, single-center, randomized controlled trial. A total of 1020 patients with CHD and GID undergoing PCI will be enrolled. Patients are randomized (1:1) to receive either rivaroxaban 10 mg plus clopidogrel 75 mg daily or aspirin 100 mg plus clopidogrel 75 mg daily; both treatments will last 6 months. The primary endpoint is Bleeding Academic Research Consortium (BARC) type 2-5 bleeding requiring medical intervention. The secondary endpoint is a composite of major adverse cardiovascular and cerebrovascular events (MACCE), including all-cause death, cardiac death, nonfatal myocardial infarction, stent thrombosis, ischemia-driven target vessel revascularization, and stroke. DISCUSSION: The objective of this study is to evaluate the efficacy and safety of rivaroxaban plus clopidogrel versus aspirin plus clopidogrel in patients with CHD and GID undergoing PCI. We aim to explore an optimized antithrombotic strategy, which achieves the same anti-ischemic effect as standard DAPT without increasing the risk of GIB, for patients with CHD and GID undergoing PCI.

trial registrationThis protocol is registered at the Chinese Clinical Trial Registry under the number ChiCTR2100044319. And this publication is based on version 1.4 of the trial protocol dated Sep 6, 2021.

Indexed as

AspirinClopidogrelCoronary Artery DiseaseGastrointestinal DiseasesMyocardial InfarctionPercutaneous Coronary InterventionRivaroxabanDrug Therapy, CombinationEquivalence Trials as TopicHemorrhageHumansPlatelet Aggregation InhibitorsProspective StudiesRandomized Controlled Trials as TopicTreatment OutcomeAspirinClopidogrelPlatelet Aggregation InhibitorsRivaroxabanDual antiplatelet therapyGastrointestinal diseasePercutaneous coronary interventionProtocolRivaroxaban

Identifiers

PMID36945020
PMCPMC10031942
OpenAlexW4328051257

What OpenQuestion holds

Textfull text, public
LicenceCC BY
reference markers read6
measurements read54
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.