NCT03051360

PCSK9 Inhibitors in the Progression of Aortic Stenosis

Proprotein Convertase Subtilisin Kexin Type 9 Inhibitor in Aortic Stenosis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Investigators plan evaluate whether PCSK9 inhibitors, a medication that can lower lipoprotein(a) and control dyslipidemia, can inhibit the progression of aortic stenosis, through a randomized controlled trial.

Detailed description

Aortic valve disease is the most common form of heart valve disease and is a major burden to society. Aortic valve disease is also expected to become more prevalent with the aging. Among aortic diseases, 'aortic stenosis (AS)', which is a narrowing of the aortic valve, and leads to symptoms of heart failure and sometimes death. For treatment of AS, the valve in replaced in a surgical to percutaneous method. Regardless of the method, valve replacement has its potential costs and complications that is an important issue that needs to be solved. Therefore, controlling the progression of AS and increasing the efficacy of medical therapy before valvular replacement is needed, is an important medico-social problem. Regarding the pathophysiology of AS, an elevation of lipoprotein(a) and dyslipidemia have been reported to be associated with the progression of cardiovascular calcification. PCSK9 inhibitors, which is a medication that can control both lipoprotein(a) and dyslipidemia may be a effective medication to control the progression of AS. Therefore, investigators will perform a randomized control trial, to compare the effect of PCSK9 inhibitors vs. placebo in its influence to AS progression.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DRUG	PCSK9 Inhibitor [EPC]	Patients will receive PCSK9 inhibitor by a biweekly injection
DRUG	Placebos	Patients will receive Placebo by a biweekly injection

Timeline

• Start date: 2017-06-01
• Primary completion: 2019-12-31
• Completion: 2020-01-01
• First posted: 2017-02-13
• Last updated: 2017-02-13

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study