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Anti-metabolites

Inclisiran for Coronary Artery Disease (PRECAD Trial)

Phase 3

Recruiting

Led By Valentin Fuster, MD, PhD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

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

Must have

Male or female subjects between 30 to 50 years of age

No prior history of coronary artery disease, cerebrovascular disease or peripheral artery disease

Must not have

Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 5 years

Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least two methods of highly effective contraception for the entire duration of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 5 years after randomization

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to study whether controlling cardiovascular risk factors in young adults without known heart disease can reduce the progression of atherosclerosis. The study will enroll 1,600 healthy young adults and randomize

Who is the study for?

This trial is for healthy young adults aged 30-50 without known cardiovascular disease. It aims to see if strict control of heart risk factors can slow down the buildup of plaque in arteries, which could lead to heart problems later on.

What is being tested?

The study tests Inclisiran, a medication that may help manage cholesterol levels. Participants will be randomly assigned to either receive Inclisiran or usual care based on current medical guidelines.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with cholesterol-lowering medications like Inclisiran include injection site reactions, muscle pain, and possibly liver-related issues.

Eligibility Criteria

Inclusion Criteria

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

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I am between 30 and 50 years old.

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I have never had heart, brain, or blood vessel diseases.

Exclusion Criteria

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

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I have a serious illness besides heart disease that may shorten my life to under 5 years.

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I am not pregnant or nursing and willing to use two effective birth control methods during the study.

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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 have a liver condition or my liver tests are significantly abnormal.

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I cannot take cholesterol-lowering medications due to health reasons.

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I can follow the study's requirements and have no health issues that would increase my risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2.5 years and 5 years after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2.5 years and 5 years after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2.5 years and 5 years after randomization for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in atherosclerotic plaque burden from baseline

Secondary study objectives

Change in Number of participants with Cardiovascular Disease (CVD)

Side effects data

From 2019 Phase 3 trial • 482 Patients • NCT03397121

12%

Nasopharyngitis

Injection site reaction

Upper respiratory tract infection

Back pain

Influenza

Acute myocardial infarction

Aortic valve stenosis

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Inclisiran

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InclisiranExperimental Treatment1 Intervention

Participants in this arm will receive the study drug (inclisiran, for 5 years). Specific measures will be implemented to achieve the following goals: LDL-C \<55 mg/dl; blood pressure \<130/80 mmHg; and HbA1c \<6.5%. Diet and lifestyle recommendations will be recommended to all patients as a first step. Follow-up will occur every 2 months until goals are achieved. If the goal is not achieved, the subsequent recommendation will be implemented. Pharmacologic treatment may be implemented as early as the first visit at the discretion of the physician. * Product Name: inclisiran * Active ingredient: inclisiran sodium * Dosage Form: Solution for Injection * Unit Dose Inclisiran sodium 300 mg/1.5 mL vial (equivalent to 284 mg inclisiran) * Route of Administration: SC use * Physical Description: Clear, colorless to pale yellow solution essentially free of particulates

Group II: Control GroupActive Control1 Intervention

Participants in this group will receive guideline directed medical treatment, according to American Heart Association/American College of Cardiology guidelines. These recommendations will be provided to the primary care physicians to be followed, according to standards of care. Follow-up visits will occur every 6 months, although patients might be seen more often according to their provider´s criteria.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Inclisiran

2021

Completed Phase 3

~2820

0 / 8Eligibility criteria met