Evidence mapPaperPMID 42201706Full record

Trial reportJAMA cardiology2026

Bempedoic Acid and Venous Thromboembolism Risk Among Statin-Intolerant Patients: A Post Hoc Analysis of the CLEAR Outcomes Randomized Clinical Trial.

Bernardo F Spiazzi, Danielle Brennan, Carolina P Zingano, Heather A Powell, Stephen J Nicholls, Steven E Nissen, Luke J Laffin

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in JAMA cardiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02993406 (A Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of Bempedoic Acid), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT02993406 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of Bempedoic Acid (ETC-1002) on the Occurrence of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant

TypeinterventionalSponsorEsperion Therapeutics, Inc.Ran2016 to 2022Enrolled13,970ConditionsCardiovascular Diseases, Statin Adverse ReactionArmsBempedoic acid 180 mg tablet, Matching placebo tablet
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Bernardo F SpiazziDepartment of Internal Medicine, Cleveland Clinic, Cleveland, Ohio.
Danielle BrennanCleveland Clinic Coordinating Center for Clinical Research, Cleveland, Ohio.
Carolina P ZinganoDepartment of Internal Medicine, Cleveland Clinic, Cleveland, Ohio.
Heather A PowellEsperion Therapeutics Inc, Ann Arbor, Michigan.
Stephen J NichollsVictorian Heart Institute, Monash University, Melbourne, Victoria, Australia.
Steven E NissenCleveland Clinic Coordinating Center for Clinical Research, Cleveland, Ohio.
Luke J LaffinCleveland Clinic Coordinating Center for Clinical Research, Cleveland, Ohio.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Importance: Venous thromboembolism (VTE), which encompasses deep vein thrombosis and pulmonary embolism, is a frequent condition that can lead to significant morbidity and mortality; statins, monoclonal antibody proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors, and their combination are associated with a reduced risk of VTE. The effect of bempedoic acid on VTE risk is unknown. Objective: To determine whether bempedoic acid is associated with a reduced risk of VTE. Design, Setting, and Participants: CLEAR Outcomes was a randomized, double-blind, placebo-controlled, cardiovascular outcomes clinical trial. Statin-intolerant individuals at high risk for or with established atherosclerotic cardiovascular disease who were aged 18 to 85 years were enrolled between December 22, 2016, and August 14, 2019, in 1250 centers across 32 countries. The statistical analysis for the present study was conducted between March 10, 2025, and February 19, 2026. Interventions: Participants were randomized to oral bempedoic acid, 180 mg, or placebo daily. Main Outcomes and Measures: The main outcome for this analysis was the time to first occurrence of VTE (composite of deep vein thrombosis or pulmonary embolism). The occurrences of deep vein thrombosis and pulmonary embolism were also assessed. Results: A total of 13 970 participants (mean [SD] age, 65.5 [9.0] years; 6740 [48.2%] female) were randomized, 6992 to bempedoic acid and 6978 to placebo. At the time of randomization, 275 participants (2.0%) had a history of VTE, and 1219 (8.7%) were receiving systemic anticoagulation. The participants were followed up for a median (IQR) of 40.6 (37.1-46.2) months. A total of 106 VTE events occurred (39 in the bempedoic acid group and 67 in the placebo group; hazard ratio [HR], 0.58; 95% CI, 0.39-0.86; P = .006). Findings were consistent for deep vein thrombosis (HR, 0.56; 95% CI, 0.31-0.996; P = .045) and pulmonary embolism (HR, 0.61; 95% CI, 0.37-0.996; P = .046). Conclusions and Relevance: Treatment with bempedoic acid among participants with statin intolerance at high risk for or with established cardiovascular disease was associated with a reduced risk of VTE. Trial Registration: ClinicalTrials.gov Identifier: NCT02993406.

Indexed as

Dicarboxylic AcidsFatty AcidsHydroxymethylglutaryl-CoA Reductase InhibitorsVenous ThromboembolismAdultAgedAged, 80 and overDouble-Blind MethodFemaleHumansMaleMiddle AgedPulmonary Embolism8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acidDicarboxylic AcidsFatty AcidsHydroxymethylglutaryl-CoA Reductase Inhibitors

Identifiers

PMID42201706
PMCPMC13217233

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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 Socratic graph.