Inclisiran for Cardiovascular Disease
(VICTORION-2P Trial)

Recruiting in Palo Alto (17 mi)

+1236 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novartis Pharmaceuticals

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing inclisiran, an injectable drug, on people with heart disease who are already on strong cholesterol-lowering medications. The goal is to see if inclisiran can further reduce the risk of heart attacks and strokes by lowering bad cholesterol levels. Participants will receive the injection periodically. Inclisiran works by significantly reducing bad cholesterol levels.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for people with a history of heart issues like heart attacks, strokes, or peripheral arterial disease. They should be on a stable cholesterol-lowering regimen but not taking PCSK9 inhibitors. Those with severe non-heart diseases, pregnant women, and individuals who've had recent cardiovascular events or used inclisiran before are excluded.

Inclusion Criteria

I have had a heart attack, stroke, or peripheral arterial disease.

I am not using nor planning to use PCSK9 inhibitors like Repatha or Praluent.

I am currently taking medication to lower my cholesterol.

Exclusion Criteria

I had a stroke more than 4 weeks ago.

I haven't taken inclisiran or similar PCSK9 drugs in the last 2 years.

You are currently pregnant or breastfeeding.

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Treatment Details

Interventions

Inclisiran (siRNA)

Trial OverviewThe study tests if Inclisiran can prevent major heart problems in those already diagnosed with heart disease compared to a placebo. Participants will randomly receive either Inclisiran sodium 300 mg or a placebo to see which is more effective at reducing cardiovascular events.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Inclisiran sodiumExperimental Treatment1 Intervention

Subcutaneous injection

Group II: PlaceboPlacebo Group1 Intervention

Subcutaneous injection

Inclisiran is already approved in China for the following indications: