American heart journal plus : cardiology research and practice · 2026
Public availability of trial-design and clinical-context information in contemporary lipoprotein(a)-targeted cardiovascular trials: A cross-sectional meta-research study.
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Tan Samuel, Gu Joyce, Yow Daniel, Zheng Lucy
Аннотация
BACKGROUND: Direct lipoprotein(a) [Lp(a)]-lowering therapies are advancing toward cardiovascular outcomes testing, but the amount of publicly available trial-design and clinical-context information varies across development stages.
OBJECTIVE: To characterize contemporary patient-enrolling direct Lp(a)-targeted pharmacologic trials and describe fixed-date public availability of predefined trial information.
METHODS: We conducted a cross-sectional meta-research study anchored in ClinicalTrials.gov with linked public protocols, statistical analysis plans, design/baseline reports, supplements, and peer-reviewed manuscripts available through May 2, 2026. Contemporary trials started on or after January 1, 2017. Two reviewers independently abstracted 12 prespecified public-information elements. Elements were classified as publicly identified or not publicly identified; no composite score or trial ranking was used.
RESULTS: Fourteen trials met inclusion criteria, representing 5 agents, 3 therapeutic platforms, and 56,983 planned or reported participants. Seven trials had Lp(a) biomarker primary endpoints, 5 had clinical cardiovascular outcomes, 1 assessed apheresis burden, and 1 assessed calcific aortic valve stenosis progression. Seven trials were published/protocol-supported and 7 registry-only. Cardiovascular/risk phenotype, prevention or special-population setting, and geographic scope were identified in all trials. Other elements were identifiable less consistently: Lp(a) unit (13/14), background lipid-lowering therapy (9/14), numeric Lp(a) threshold (8/14), PCSK9/inclisiran handling (8/14), demographic information (8/14), CKD/eGFR criteria (6/14), heart failure criteria (6/14), diabetes criteria (5/14), and LDL-C context (3/14).
CONCLUSIONS: Public availability varied across contemporary Lp(a)-targeted trials at the data lock, particularly for registry-only programs. These findings describe fixed-date public retrievability and should not be interpreted as protocol deficiency, registry noncompliance, trial quality, efficacy, safety, or regulatory readiness.
OBJECTIVE: To characterize contemporary patient-enrolling direct Lp(a)-targeted pharmacologic trials and describe fixed-date public availability of predefined trial information.
METHODS: We conducted a cross-sectional meta-research study anchored in ClinicalTrials.gov with linked public protocols, statistical analysis plans, design/baseline reports, supplements, and peer-reviewed manuscripts available through May 2, 2026. Contemporary trials started on or after January 1, 2017. Two reviewers independently abstracted 12 prespecified public-information elements. Elements were classified as publicly identified or not publicly identified; no composite score or trial ranking was used.
RESULTS: Fourteen trials met inclusion criteria, representing 5 agents, 3 therapeutic platforms, and 56,983 planned or reported participants. Seven trials had Lp(a) biomarker primary endpoints, 5 had clinical cardiovascular outcomes, 1 assessed apheresis burden, and 1 assessed calcific aortic valve stenosis progression. Seven trials were published/protocol-supported and 7 registry-only. Cardiovascular/risk phenotype, prevention or special-population setting, and geographic scope were identified in all trials. Other elements were identifiable less consistently: Lp(a) unit (13/14), background lipid-lowering therapy (9/14), numeric Lp(a) threshold (8/14), PCSK9/inclisiran handling (8/14), demographic information (8/14), CKD/eGFR criteria (6/14), heart failure criteria (6/14), diabetes criteria (5/14), and LDL-C context (3/14).
CONCLUSIONS: Public availability varied across contemporary Lp(a)-targeted trials at the data lock, particularly for registry-only programs. These findings describe fixed-date public retrievability and should not be interpreted as protocol deficiency, registry noncompliance, trial quality, efficacy, safety, or regulatory readiness.