CompletedNot Applicable

In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Disease

France204,691 participantsStarted 2023-11-03

Plain-language summary

Study CKJX839B1FR01 in an In silico trial to predict the efficacy of Inclisiran therapy on major adverse cardiovascular events (MACE) and cardiovascular (CV) death in virtual patients with atherosclerotic cardiovascular disease (ASCVD) and elevated LDL-C.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. Patients with atherosclerotic CV disease, defined as any of the following
✓. Fasting LDL-C ≥ 70 mg/dL
✓. Under stable (≥ 4 weeks) well-tolerated high-intensity statin with or without ezetimibe.

What they're measuring

Time to the first occurrence between trial start and end of follow-up of any component of 3P-MACE (composite of CV death, non-fatal MI or non-fatal ischemic stroke)

Timeframe: 5 years of follow-up

Time to the first occurrence between trial start and end of follow-up of CV death

Timeframe: 5 years of follow-up

Trial details

NCT IDNCT05974345

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-12-15

View on ClinicalTrials.gov More Atherosclerotic Cardiovascular Disease trials