Evidence map›Paper›PMID 42291052›Full record

ArticleAmerican journal of preventive cardiology2026

Enhancing representation in cardiovascular trials: Lessons from Lp(a)FRONTIERS EXPANSION in United States Black and Hispanic patients with elevated lipoprotein(a) and established atherosclerotic cardiovascular disease.

Keith C Ferdinand, Fatima Rodriguez, Alok R Amraotkar, Subha Venkataraman, Imran Ayaz, Oliver Antequera, Hui Cao, Wenyue Zhu, Jing Wang, Michael D Shapiro

Registry-linked trialAbstract read
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In one paragraph

Article in American journal of preventive 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 NCT06267560 (A Randomized Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Pelacarsen), 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.

NCT06267560 phase3completednot on this map

A Randomized Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Pelacarsen (TQJ230) in US Black/African American & Hispanic Patient Populations With Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease

TypeinterventionalSponsorNovartis PharmaceuticalsRan2024 to 2026Enrolled422ConditionsElevated Lp(a) and Established Atherosclerotic Cardiovascular DiseaseArmsTQJ230, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

10 authors.

Keith C FerdinandTulane University School of Medicine, John W Deming Department of Medicine, Section of Cardiology, New Orleans, LA, USA.
Fatima RodriguezStanford University School of Medicine, Cardiovascular Medicine and the Center for Digital Health, Stanford, CA, USA.
Alok R AmraotkarNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Subha VenkataramanNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Imran AyazNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Oliver AntequeraNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Hui CaoNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Wenyue ZhuNovartis Pharmaceuticals UK Ltd, London, United Kingdom.
Jing WangNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Michael D ShapiroWake Forest University School of Medicine, Center for Prevention of Cardiovascular Disease, Department of Cardiovascular Medicine, Winston-Salem, NC, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Black and Hispanic individuals are disproportionately impacted by elevated levels of lipoprotein(a) [Lp(a)] and atherosclerotic cardiovascular disease (ASCVD). Despite this, these populations are underrepresented in cardiovascular clinical trials. Herein, the strategies aimed to improve minority representation during the study design and recruitment phase of the Lp(a)FRONTIERS EXPANSION trial are described. Baseline characteristics and study attrition to date are also presented. Methods: Lp(a)FRONTIERS EXPANSION (NCT06267560) is a randomized, double-blind, phase 3b, placebo-controlled trial evaluating pelacarsen in United States (US) Black/African American and/or Hispanic individuals with elevated Lp(a) (≥125 nmol/L) and established ASCVD. Eligible individuals were randomized 2:1 to receive monthly subcutaneous injections of either pelacarsen 80 mg or placebo, for 12 months. Various design and operational strategies were employed to improve enrollment and retention under four key themes: study design, site selection and engagement, enrollment support, and barrier removal. Results: Overall, 422 patients were randomized to receive pelacarsen or placebo, with enrollment completed 1 year ahead of schedule. Patients were randomized from 103 sites across 21 US states/territories (including Puerto Rico); 8 sites recruited ≥10 patients. At data cut-off (7 October 2025), 64 patients had completed the trial. The mean±standard deviation age was 63.2 ± 9.1 years, 50.7% (214/422) of patients were male, and 68.0% (287/422) identified as Black/African American. Median (Q1, Q3) Lp(a) levels were 110.3 (79.4, 143.7) mg/dL (226.6 [165.8, 299.7] nmol/L). Conclusion: The Lp(a)FRONTIERS EXPANSION trial suggests that deliberate, culturally tailored design and operational strategies may improve cardiovascular trial participation by US minority populations. Results from Lp(a)FRONTIERS EXPANSION will provide critical insights into the efficacy and safety profile of pelacarsen in treating elevated Lp(a).

Indexed as

ASCVDLipoprotein(a)pelacarsenTQJ230Underrepresented diverse patients

Identifiers

PMID42291052
PMCPMC13261181

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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.