Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05360446
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Inclisiran sodium 300 mg — DRUG
    Subcutaneously administered on Days 1, Month 3 (Day 90), and every 6 months thereafter.
  • Placebo — DRUG
    Subcutaneously administered on Day 1, Month 3 (Day 90), and every 6 months thereafter.

Study Details

CKJX839D12303 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo taken in addition to statin medication can effectively reduce the total amount of plaque formed in the heart's vessels as measured by coronary computed tomography angiography (CCTA) from baseline to month 24. This study is being conducted in eligible participants with a diagnosis of non-obstructive coronary artery disease (NOCAD), where the coronary arteries are blocked less than 50%, and with no previous cardiovascular events.

Key Dates

Start date
Jul 8, 2022
Status verified
May 2026
Primary completion
Oct 26, 2026
Completion
Oct 26, 2026

Study Design

Enrollment
608 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Subcutaneous injection
  • Experimental: Inclisiran sodium
    Subcutaneous injection

Primary Outcome Measure

Percentage change in total coronary atheroma volume [ Time Frame: From baseline to month 24 ]

Locations (27)

FacilityCityStateZIPSite coordinators
Heart Center Research LlcHuntsvilleAlabama35801-
Alaska Heart and VascularAnchorageAlaska99508-
Cardiovascular Res FoundBeverly HillsCalifornia90210-
UC San Diego HealthLa JollaCalifornia92037-
Stanford Health CareStanfordCalifornia94305-
Lundquist Inst BioMed at HarborTorranceCalifornia90509-2910-
Bridgeport HospitalBridgeportConnecticut06610-
George Washington Univ Medical CtrWashington D.C.District of Columbia20037-
Inpatient Research Clinical LLCMiami LakesFlorida33014-
NorthShore University Health SystemEvanstonIllinois60201-
Reid Physician AssociatesRichmondIndiana47374-
Midwest Heart and Vascular SpecOverland ParkKansas66211-
Anderson Medical ResearchFt. WashingtonMaryland20744-
Minneapolis Heart InstituteMinneapolisMinnesota55407-
R Ins For Heart And Vascular HealthRenoNevada89502-
Cardio Metabolic InstituteSomersetNew Jersey08873-
Icahn School of Med at Mt SinaiNew YorkNew York10029-
State Uni of NY at Stony BrookStony BrookNew York11794-3362-
Westchester Medical CenterValhallaNew York10595-
Aultman HospitalCantonOhio44710-
Oregon Health Sciences UniversityPortlandOregon97239-
Soltero Cardiovascular Research CenterDallasTexas75226-
Orion MedicalHoustonTexas77034-
Inova Fairfax HospitalFalls ChurchVirginia22042-
Virginia HeartFalls ChurchVirginia22042-
Swedish Medical Center-Cardiovascular ResearchSeattleWashington98122-
Univ of Washington Medical CenterSeattleWashington98195-

Find similar trials in Huntsville, AL

By research site
Heart Center Research Llc· Huntsville, ALAlaska Heart and Vascular· Anchorage, AKCardiovascular Res Found· Beverly Hills, CAUC San Diego Health· La Jolla, CAStanford Health Care· Stanford, CALundquist Inst BioMed at Harbor· Torrance, CA

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