Inclisiran for Angioplasty

(V-INTERVENTION Trial)

Recruiting at 4 trial locations

Overseen By Jen Holt

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Duke University

Must be taking: Statins

Must not be taking: PCSK9 inhibitors

Disqualifiers: Liver disease, Neoplasm, Kidney disease, others

Stay on Your Current Meds You can continue your current medications while participating

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 36-45 months

6000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if inclisiran can prevent heart and limb problems in individuals who recently underwent a procedure to open blocked blood vessels. Inclisiran, already used to lower bad cholesterol (LDL-C), is administered as an injection twice a year. Participants will receive either inclisiran or a placebo (a harmless, inactive substance) to compare results. This trial may suit those who have had a successful angioplasty or similar procedure within the last two weeks for heart or leg artery issues. As a Phase 4 trial, inclisiran has FDA approval and proven effectiveness, and this research seeks to understand its benefits for more patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot use an open-label PCSK9 inhibitor during the study, and there may be other prohibited therapies listed in the trial protocol.

What is the safety track record for inclisiran?

Research has shown that inclisiran is generally safe for people. In studies, serious side effects occurred in 11% of those taking inclisiran, compared to 8% of those taking a placebo (a harmless pill). This indicates that most people did not experience serious side effects. Another study found inclisiran safe when administered soon after an acute coronary syndrome. Inclisiran also lowers LDL cholesterol in high-risk patients and has FDA approval for this purpose. Overall, it is well tolerated, with no major safety concerns identified in long-term studies. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Inclisiran is unique because it offers a new way to manage cholesterol levels in patients undergoing angioplasty. Unlike traditional treatments that require frequent dosing, Inclisiran uses a small interfering RNA (siRNA) mechanism to lower LDL cholesterol by targeting and degrading PCSK9 mRNA. This approach allows for less frequent dosing—just two injections per year—making it more convenient for patients. Researchers are excited because this could lead to more consistent cholesterol control with fewer interruptions to patients' lives.

What is the effectiveness track record for inclisiran in preventing cardiovascular and limb events?

Research has shown that inclisiran can lower LDL-C, often called "bad" cholesterol, by about 50% with just two injections a year. The FDA has approved it for this use. While inclisiran primarily manages cholesterol levels, less information exists on its direct impact on heart problems. In this trial, participants will receive either inclisiran sodium or a placebo to further investigate its effects. Previous studies demonstrated that patients using inclisiran after other cholesterol treatments achieved better results than those relying solely on standard methods. Although it effectively lowers cholesterol, its full effects on heart and limb health remain under study. ^{1 6 7 8 9}

Who Is on the Research Team?

Schuyler Jones, MD

Principal Investigator

Duke Clinical Research Institute

Marc Bonaca, MD

Principal Investigator

Colorado Prevention Center

Roxana Mehran, MD

Principal Investigator

Mt Sinai

Manesh Patel, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for patients who have recently undergone successful heart or leg artery procedures (PCI or PVI) to improve blood flow, and are at risk of major cardiovascular events. They must consent to participate and can only be randomized after any planned additional interventions.

Inclusion Criteria

I have signed the consent form to participate in this study.

I had a successful heart or leg artery procedure within the last 14 days.

I can join the trial after completing all planned treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive inclisiran or placebo subcutaneous injections on Day 1, Month 3, and every 6 months thereafter

36-45 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

27-36 months

What Are the Treatments Tested in This Trial?

Interventions

• Inclisiran

Trial Overview The study tests Inclisiran, a twice-yearly subcutaneous injection designed to lower LDL-C cholesterol levels as an adjunct with statins, against a placebo. It aims to see if Inclisiran can prevent serious heart and limb events post-angioplasty.

How Is the Trial Designed?

Group I: Inclisiran Sodium Active Control 1 Intervention

Inclisiran sodium 300 mg subcutaneous injection

Group II: Placebo Placebo Group 1 Intervention

Normal saline 1.5 ml subcutaneous injection

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Mount Sinai Hospital, New York

Collaborator

Trials

37

Recruited

892,000+

Novartis Pharmaceuticals

Industry Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Colorado Prevention Center

Collaborator

Trials

13

Recruited

22,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11868277/

Current usage of inclisiran for cardiovascular diseases Although the studies showed inclisiran to lower LDL-C effectively, the evidence is still limited with regards to cardiovascular outcomes data.

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.032031

Harnessing RNA Interference for Cholesterol Lowering Twice‐yearly maintenance subcutaneous inclisiran (following initial loading doses at Day 1 and Day 90) reduces circulating LDL‐C levels by ≈50% ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2529912325000129

Efficacy, benefit and safety of inclisiran In this trial, the percent change in LDL-C from baseline to day 510 was a 39.7% (95% CI: –43.7 to –35.7) reduction in the inclisiran group and an 8.2% (95% CI: ...

4. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2024/04/05/03/20/victorion-initiate

Comparison of an “Inclisiran First” Strategy With Usual ... VICTORION-INITIATE demonstrated that employing inclisiran directly after maximizing statin therapy was more effective than usual, real-world ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10233093/

New approaches to reduce recurrent PCI: to angioplasty ... EPA was effective in reducing PCI with a HR of 0.68 [95% CI: 0.59–0.79, P < 0.0001)] and also coronary artery bypass graft surgery, with a HR of 0.61 [95% CI: ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2667089525000264

Inclisiran for fast-track lipid-lowering treatment early after ... Inclisiran, taken within one month of ACS hospitalisation, was safe. •. This study suggests that inclisiran should be further studied as a valuable addition to ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa1615758

Inclisiran in Patients at High Cardiovascular Risk with ... Serious adverse events occurred in 11% of the patients who received inclisiran and in 8% of the patients who received placebo. Injection-site ...

8. tctmd.com tctmd.com/news/no-safety-concerns-seen-inclisiran-large-orion-analysis

No Safety Concerns Seen With Inclisiran in Large ORION ... Prolonged exposure to inclisiran (Leqvio; Novartis), the small-interfering RNA therapy (siRNA) that lowers LDL-cholesterol levels, is safe and ...

9. academic.oup.com academic.oup.com/eurjpc/advance-article/doi/10.1093/eurjpc/zwaf214/8115346

Efficacy and safety of inclisiran based on background lipid ... Inclisiran was overall well tolerated with all background LLT treatments, consistent with its established safety profile. Graphical Abstract. Open in new tab ...