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siRNA
Inclisiran for Cardiovascular Disease (V-INITIATE Trial)
Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 90, day 180, day 270 and day 330
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing whether adding inclisiran to statin therapy helps adults with heart disease and high cholesterol better than usual care. Inclisiran helps lower bad cholesterol by aiding the liver in removing it from the blood.
Eligible Conditions
- Atherosclerotic Cardiovascular Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 90, day 180, day 270 and day 330
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 90, day 180, day 270 and day 330
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent Change From Baseline in LDL-C
Percentage of Participants Who Discontinued Statin Therapy
Secondary study objectives
Absolute Change From Baseline in LDL-C
Absolute Change in Lipids and Other Lipoproteins From Baseline
Average Absolute Change From Baseline in LDL-C Levels Across Visits
+10 moreSide effects data
From 2019 Phase 3 trial • 482 Patients • NCT0339712112%
Nasopharyngitis
9%
Injection site reaction
7%
Upper respiratory tract infection
7%
Back pain
5%
Influenza
1%
Acute myocardial infarction
1%
Aortic valve stenosis
100%
80%
60%
40%
20%
0%
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: Inclisiran FirstExperimental Treatment1 Intervention
Inclisiran sodium 300 mg 1.5 ml (equivalent to 284 mg of inclisiran) + usual care
Group II: Usual CareActive Control1 Intervention
Treating physicians were recommended to treat patients in accordance with the 2018 ACC/AHA guidelines
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inclisiran
2021
Completed Phase 3
~2820
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,905 Previous Clinical Trials
4,207,665 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a bad reaction or allergy to any of the study treatments or their ingredients, or to similar drugs in the past.You have a history of heavy alcohol or drug abuse within the past 5 years. However, if you only use drugs occasionally and not in a problematic way, you are still eligible to participate.You have experienced a serious heart rhythm problem within the past 3 months that is not controlled by medication or treatment.You have a serious illness that is not related to the heart and may shorten your life expectancy to less than 2 years.You had cancer and needed surgery, radiation therapy, or medication for it within the past two years.
Research Study Groups:
This trial has the following groups:- Group 1: Inclisiran First
- Group 2: Usual Care
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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