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NCT06996223

A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy of PCSK-9 Inhibitors in Delaying the Progression of Calcified Aortic Valve Disease

Not yet recruiting EARLY_PHASE1 Last updated 30 May 2025
What this trial tests

EARLY_PHASE1 trial testing The Group A received PCSK9 inhibitor plus statin therapy in Aortic Stenosis in 316 participants. Not yet recruiting.

Timeline
1 June 2025
Primary endpoint
1 June 2027
30 December 2027

Quick facts

Lead sponsorNanfang Hospital, Southern Medical University
PhaseEARLY_PHASE1
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment316
Start date1 June 2025
Primary completion1 June 2027
Estimated completion30 December 2027

Drugs / interventions tested

Conditions studied

Sponsor

Nanfang Hospital, Southern Medical University

Who can join

18 and older, any sex, with Aortic Stenosis or PCSK9 Inhibitor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this clinical trial is to understand whether the drug PCSK9 inhibitor can slow the progression of calcific aortic valve disease and to understand the safety of the drug. The primary objective of the study was to evaluate whether PCSK9 inhibitors could delay the progression of aortic stenosis in patients with aortic stenosis. Secondary objectives: 1) To evaluate whether PCSK9 inhibitors can delay the progression of valve calcification in patients with aortic stenosis;2) To evaluate whether PCSK9 inhibitors can reduce long-term adverse events in patients with aortic stenosis;3) To evaluate the effect of PCSK9 inhibitors on circulating Lp(a) levels in patients with aortic stenosis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Aortic Stenosis

Currently open trials in the same condition.

Other Nanfang Hospital, Southern Medical University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06996223.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing