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siRNA

Inclisiran for Acute Coronary Syndrome (V-INCEPTION Trial)

Phase 3

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Calculated glomerular filtration rate >20 mL/min by estimated glomerular filtration rate (eGFR)

Must not have

New York Heart Association (NYHA) class IIIb or IV heart failure or last known left ventricular ejection fraction <25%.

Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation at the time of screening.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, after day 90 up to day 330

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will study whether inclisiran, a new cholesterol-lowering drug, is effective in reducing LDL-cholesterol in patients who have recently experienced an ACS and are already taking a statin drug.

Who is the study for?

This trial is for adults who've had a recent heart-related emergency (Acute Coronary Syndrome) and have high bad cholesterol levels despite taking statins. They should not be on other experimental treatments, have severe heart failure or life-threatening diseases, or plan to undergo heart procedures soon.

What is being tested?

The study tests if adding Inclisiran to usual care lowers bad cholesterol more effectively than usual care alone in patients with recent Acute Coronary Syndrome. It aims to establish a systematic LDL-cholesterol management pathway.

What are the potential side effects?

Inclisiran may cause side effects like injection site reactions, allergic responses, common cold symptoms, and potential liver enzyme elevations. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function, measured by eGFR, is above 20 mL/min.

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My kidney function, measured by eGFR, is above 20 mL/min.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My heart's pumping ability is severely reduced.

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I have had serious heart rhythm problems in the last 3 months that are not controlled by medication or procedures.

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I have a serious illness besides heart disease that may shorten my life to under 2 years.

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I haven't used any experimental drugs or devices in the last 30 days or longer.

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I had a heart problem again less than 2 weeks ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, after day 90 up to day 330

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, after day 90 up to day 330

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after day 90 up to day 330 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body Weight Changes

Percentage (%) change in low-density lipoprotein cholesterol (LDL-C)

Secondary study objectives

Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C)

Absolute change in apolipoprotein B, very low density lipoprotein, high density lipoprotein cholesterol, lipoprotein (a), non-high density lipoprotein cholesterol, and total cholesterol

Achieving ≥ 50% reduction from baseline in low-density lipoprotein cholesterol (LDL-C) (yes, no)

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