Inclisiran for Cardiovascular Disease

(V-INCLUSION Trial)

Recruiting in Palo Alto (17 mi)

+29 other locations

Overseen by Neha Pagidipati, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Duke University

Must be taking: Statins

Must not be taking: PCSK9 antibodies, Inclisiran

Disqualifiers: Pregnancy, Heart failure, Arrhythmia, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

VictORION-INCLUSION (V-INCLUSION) seeks to evaluate the effectiveness of inclisiran as an innovative therapy with the potential to help bridge care gaps in historically understudied and undertreated populations by leveraging electronic health records (EHR) in multiple US Healthcare Systems (HCS) to systematically identify those at high risk for and already diagnosed with ASCVD for more expeditious achievement of LDL-C targets.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on statin therapy or have documented statin intolerance to participate.

How is the drug Inclisiran unique for treating cardiovascular disease?

Inclisiran is unique because it works by targeting a specific protein involved in cholesterol production, which helps lower LDL cholesterol levels. It is administered as an injection only twice a year, making it more convenient compared to other treatments that require more frequent dosing.

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Eligibility Criteria

The VictORION-INCLUSION trial is for adults over 18 with cardiovascular disease or at high risk, as noted in their health records. Participants must have LDL cholesterol above certain levels despite being on statins or having a documented intolerance to them. The study focuses on including underrepresented groups such as women, ethnic minorities, and rural residents.

Inclusion Criteria

I meet all the required conditions for the study.

I am 18 years old or older.

I am willing and able to follow the study's procedures after giving informed consent.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Randomized, controlled, multicenter, open-label trial comparing inclisiran and usual care versus usual care alone

52 weeks

Visits at Day 90, Day 270, and Day 360

Treatment Part 2

Single arm trial with usual care participants initiating inclisiran at Day 360, with additional doses on Day 450 and Day 630

36 weeks

Doses on Day 360, Day 450, and Day 630

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Participant Groups

This trial tests Inclisiran's ability to manage cholesterol in heart disease patients. It uses electronic health records from US Healthcare Systems to quickly identify and treat those at high risk or with diagnosed atherosclerotic cardiovascular disease (ASCVD) to lower LDL-C levels faster.

Group I: Inclisiran Experimental Treatment 1 Intervention

Inclisiran + Usual Care

Group II: Usual Care Active Control 1 Intervention

Usual Care

Inclisiran is already approved in European Union, United States, China for the following indications:

🇪🇺 Approved in European Union as Leqvio for:

• Primary hypercholesterolemia (heterozygous familial and non-familial)
• Mixed dyslipidemia

🇺🇸 Approved in United States as Leqvio for:

• Heterozygous familial hypercholesterolemia (HeFH)
• Clinical atherosclerotic cardiovascular disease (ASCVD)
• Primary hypercholesterolemia

🇨🇳 Approved in China as Leqvio for:

• Primary hypercholesterolemia (heterozygous familial and non-familial)
• Mixed dyslipidemia

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Wellstar Paulding Hiram, GA

Houston Methodist Houston, TX

University of Utah Salt Lake City, UT

Medical College of Wisconsin Milwaukee, WI

More Trial Locations

Who Is Running the Clinical Trial?

Duke University Lead Sponsor

Novartis Pharmaceuticals Industry Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

The PRESTO (Prevention of restenosis with tranilast and its outcomes) protocol: a double-blind, placebo-controlled trial. [2019] Tranilast is a unique drug in clinical development for the prevention of restenosis after percutaneous transluminal coronary revascularization (PTCR). Tranilast interferes with proliferation and migration of vascular medial smooth muscle cells induced by platelet-derived growth factor and transforming growth factor beta1. Collagen synthesis in vascular medial smooth muscle cells is inhibited by tranilast, which also inhibits the release or production of cyclooxygenase-2 and restores cytokine-induced nitric oxide production. These mechanisms may contribute to the reduction of angiographic restenosis after coronary intervention previously reported in clinical studies.

2. United States pubmed.ncbi.nlm.nih.gov

Performance of the XLIMUS Sirolimus-Eluting Coronary Stent in Very Complex Lesions. [2022] Stent delivery failure may occur especially when treating complex coronary artery stenosis. XLIMUS (CARDIONOVUM GmbH, Bonn, Germany) is a new sirolimus-eluting stent (SES) with the following features: 1) cobalt chromium stent platform, with low (73 μm) strut thickness, (2) biodegradable polymer, and 3) potent antiproliferative drug (Sirolimus). Preliminary data suggest that XLIMUS SES may be ideal for the treatment of complex lesions.

3. Netherlands pubmed.ncbi.nlm.nih.gov

Preventive effect of an antiallergic drug, pemirolast potassium, on restenosis after stent placement: quantitative coronary angiography and intravascular ultrasound studies. [2016] The preventive effect of pemirolast against restenosis after coronary stent placement was evaluated.

4. United States pubmed.ncbi.nlm.nih.gov

Intravascular ultrasound results from the NEVO ResElution-I trial: a randomized, blinded comparison of sirolimus-eluting NEVO stents with paclitaxel-eluting TAXUS Liberté stents in de novo native coronary artery lesions. [2016] The NEVO sirolimus-eluting stent (NEVO SES) is a novel cobalt-chromium stent combining sirolimus release from reservoirs with bioabsorbable polymer to reduce spatial and temporal polymer exposure. The aim of this study was to assess the arterial response to the NEVO SES in a randomized, blinded comparison versus the surface-coated TAXUS Liberte paclitaxel-eluting stent (TAXUS Liberté PES) in human native coronary lesions using intravascular ultrasound (IVUS).

5. China pubmed.ncbi.nlm.nih.gov

Four-year clinical follow-up of the first-in-man randomized comparison of a novel sirolimus eluting stent with abluminal biodegradable polymer and ultra-thin strut cobalt-chromium alloy: the INSPIRON-I trial. [2020] The Inspiron™ sirolimus-eluting stent (SES) is a low-dose, ultra-thin-strut cobalt-chromium stent abluminally coated with biodegradable polymers (BP). Previous results from the INSPIRON-I trial, a first-in-man study, have proven the efficacy of the novel stent in reducing neointimal proliferation. The present report aims at evaluating the long-term clinical outcomes of patients enrolled into the INSPIRON-I trial (Clinical Trials Gov. identifier: NCT01093391).