Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention

PHASE4RecruitingINTERVENTIONAL
Enrollment

6,000

Participants

Timeline

Start Date

July 23, 2025

Primary Completion Date

October 31, 2029

Study Completion Date

December 31, 2029

Conditions
Percutaneous Coronary InterventionPeripheral Endovascular Intervention
Interventions
DRUG

Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL

300 mg (equivalent to 284 mg inclisiran) in 1.5 mL subcutaneous injection at Day 0; Day 90; \& every 6 months thereafter

DRUG

Normal Saline (Placebo)

Normal saline placebo subcutaneous injection given at Day 0, Day 90; \& every 6 months thereafter

Trial Locations (5)

27560

RECRUITING

Duke Cardiology, Morrisville

79106

RECRUITING

PharmaTex Research, Amarillo

90211

RECRUITING

Pacific Oaks Medical Group, Beverly Hills

92663

RECRUITING

Radin Cardiovascular Medical Group, Inc, Newport Beach

08807

RECRUITING

Advanced Heart Care LLC, Bridgewater

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

collaborator

Colorado Prevention Center

OTHER

collaborator

Mount Sinai Hospital, New York

OTHER

lead

Duke University

OTHER