Atherosclerotic Cardiovascular DiseasePhase 3V-INITIATENCT04929249
A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)
A Phase 3 study testing Inclisiran in people with Atherosclerotic Cardiovascular Disease, run by Novartis Pharmaceuticals at 43 sites in United States.
Trial summary
The purpose of this study was to assess the effectiveness of an "inclisiran first" implementation strategy (addition of inclisiran to maximally tolerated statin therapy immediately upon failure to achieve acceptable LDL-C with maximally tolerated statin therapy alone) compared to usual care in an atherosclerotic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- What is being tested?
- Inclisiran
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 43 sitesUnited States
- Study dates
- 25 Jun 2021to 15 Sep 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Participants meeting any of the following criteria are not eligible for inclusion in this study.
- Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study, and/or put the participant at significant risk (according to investigator's [or delegate] judgment) if he/she participates in the clinical study
- An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results
- New York Heart Association (NYHA) class III or IV heart failure or last known left ventricular ejection fraction <30%
- Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation at the time of screening
- Major adverse cardiovascular event within 6 months prior to randomization
Show all 28Show fewer
- Uncontrolled severe hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg prior to randomization despite antihypertensive therapy
- Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years
- History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the two years prior to randomization
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of investigational drug. Basic contraception methods include:
- Total abstinence (when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
- Male sterilization (at least 6 m prior to screening). For female participants in the study, the vasectomized male partner should be the sole partner for that participant
- Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps)
- Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking investigational drug.
- Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
- Known history of alcohol and/or drug abuse within the last 5 years (occasional casual users of illicit drugs in the opinion of the investigators are not excluded)
- Treatment with other investigational products or devices within 30 days or five half-lives of the screening visit, whichever is longer
- History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes
- Planned use of other investigational products or devices during the course of the study
- Any condition that according to the investigator could interfere with the conduct of the study, such as but not limited to:
- Participants who are unable to communicate or to cooperate with the investigator
- Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study (including participants whose cooperation is doubtful due to drug abuse or alcohol dependency)
- Unlikely to comply with the protocol requirements, instructions, and study-related restrictions (e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study - including potential participants who indicate that their participation is contingent on receiving inclisiran)
- Have any medical or surgical condition, which in the opinion of the investigator would put the participant at increased risk from participating in the study
- Persons directly involved in the conduct of the study
- Previous or current treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9 or ezetimibe
- Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or alanine aminotransferase (ALT) elevation >3x ULN, aspartate aminotransferase (AST) elevation >3x ULN, or total bilirubin elevation >2x ULN (except patients with Gilbert's syndrome) at screening confirmed by a repeat measurement at least one week apart
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Alexandria Cardiology Clinic .
Alexandria, Louisiana, 71301
Medstar Health Research Institute .
Baltimore, Maryland, 21218
MedStar Good Samaritan Hospital
Baltimore, Maryland, 21239
Cypress Heart and Vascular Center
Cypress, Texas, 77429
NW Houston Neuro Comp Sleep Med Ctr
Cypress, Texas, 77429
St Elizabeth Healthcare .
Edgewood, Kentucky, 41017
Inspira Health Network The Heart House
Elmer, New Jersey, 08318
New York Presbyterian Queens .
Flushing, New York, 11355
Integrative Research Associates Inc
Fort Lauderdale, Florida, 33312
d-b-a Greenwich Cardio Assoc CLCZ696BUS08
Greenwich, Connecticut, 06830
Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
Elite Cardiac Research Center .
Hialeah, Florida, 33012
Primecare Medical Group
Houston, Texas, 77024
Synergy Group Medical LLC .
Houston, Texas, 77061
Synergy Group Medical LLC
Houston, Texas, 77061
Northwest Houston Cardiology PA .
Houston, Texas, 77070
Indiana University Health
Indianapolis, Indiana, 46202
University of Florida Health Science Center .
Jacksonville, Florida, 32209
Jacksonville Ctr for Clin Rea Encore Research Group
Jacksonville, Florida, 32216
Gateway Cardiology PC CACZ885M2301_Younis
Jerseyville, Illinois, 62052
Internal Medicine and Cardiology
Kissimmee, Florida, 34741
Bryan LGH Heart Inst Intigrated Cardiology Group .
Lincoln, Nebraska, 68506
New Jersey Heart
Linden, New Jersey, 07036
ARcare Center for Clinical Research .
Little Rock, Arkansas, 72205
ARcare Center for Clinical Research
Little Rock, Arkansas, 72205
Keck Medical Center USC .
Los Angeles, California, 90033
Centra Health .
Lynchburg, Virginia, 24501
Marshfield Medical Clinic .
Marshfield, Wisconsin, 54449
Synergy Groups Medical LLC
Missouri City, Texas, 77459
Exemplar Research Inc .
Morgantown, West Virginia, 26501
Alliance for Multispecialty Res LLC
Nashville, Tennessee, 37203
New York Presbyterian Hospital .
New York, New York, 10021
Capital Area Research LLC Suite 330
Newport, Pennsylvania, 17074
Capital Area Research
Newport, Pennsylvania, 17074
Affinity Health Corp
Oak Brook, Illinois, 60523
National Clinical Research .
Richmond, Virginia, 23294
Cardiology Ass of Fairfield County .
Stamford, Connecticut, 06905
State Uni of NY at Stony Brook .
Stony Brook, New York, 11794-3362
Montefiore Hospital .
The Bronx, New York, 10467 2490
Bay Area Heart Ace Clinical Resh Gp .
Webster, Texas, 77598
Marshfield Clinic Health System
Weston, Wisconsin, 54476
Northwestern Medicine Northwestern University .
Winfield, Illinois, 60190
Cardiology Consultants of Philadelphia
Yardley, Pennsylvania, 19067
About this study
Official title: A Randomized, Multicenter, Open-label Trial Comparing the Effectiveness of an "Inclisiran First" Implementation Strategy to Usual Care on LDL Cholesterol (LDL-C) in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C (≥70 mg/dL) Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)
The purpose of this study was to assess the effectiveness of an "inclisiran first" implementation strategy (addition of inclisiran to maximally tolerated statin therapy immediately upon failure to achieve acceptable LDL-C with maximally tolerated statin therapy alone) compared to usual care in an atherosclerotic cardiovascular disease (ASCVD) population.
Read the detailed description
The study design was a randomized, two-arm, parallel-group, open-label, multicenter, clinical trial comparing an "inclisiran first" implementation strategy to usual care (1:1 randomization) with established ASCVD and elevated LDL-C (or non-HDL-C) despite treatment with maximally tolerated statin therapy.
Eligible patients had established ASCVD and elevated LDL-C levels ≥ 70 mg/dL (or non-HDL-C ≥ 100 mg/dL) despite treatment with maximally tolerated statin therapy.
In the "inclisiran first" implementation strategy group post-randomization, addition of other non-statin LDL-C lowering therapies (e.g., ezetimibe or bempedoic acid, excluding PCSK9 inhibiting monoclonal antibodies) were allowed to reach acceptable LDL-C levels. In the "inclisiran first" implementation strategy group, inclisiran was administered initially at randomization, 90 days later, and six months, thereafter.
- Conditions
- Atherosclerotic Cardiovascular Disease
- Being tested
- Inclisiran
- Keywords
- Hyperlipidemia, Secondary Cardiovascular Prevention, Atherosclerotic Cardiovascular Disease (ASCVD), Hypercholesterolemia, Lipid lowering therapies, Inclisiran
- Medical subject headings
- Atherosclerosis, Hyperlipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InclisiranDrug
Also called Inclisiran First
Inclisiran sodium 300 mg/1.5 ml (equivalent to 284 mg inclisiran liquid) in prefilled syringe (PFS).
| Study group | Role | What they receive |
|---|---|---|
| Inclisiran First | Experimental | Inclisiran sodium 300 mg 1.5 ml (equivalent to 284 mg of inclisiran) + usual care Receives: Drug: Inclisiran |
| Usual Care | No intervention | Treating physicians were recommended to treat patients in accordance with the 2018 ACC/AHA guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in LDL-C
Percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) of an "inclisiran first" implementation strategy compared to usual care at Day 330.
Measured: Baseline, Day 330
Percentage of Participants Who Discontinued Statin Therapy
Percentage of patients who discontinued statin therapy ≥ 30 days before the end-of-study visit of an "inclisiran first" implementation strategy compared to usual care, for patients in the FAS excluding those with a medical history of statin intolerance.
Measured: Day 330
Secondary outcomes (13)
Absolute Change From Baseline in LDL-C
Absolute change in Low-Density Lipoprotein Cholesterol (LDL-C) of an "inclisiran first" implementation strategy compared to usual care at Day 330
Measured: Baseline, Day 330
Average Percent Change From Baseline in LDL-C Levels Across Visits
Average percent change in Low-Density Lipoprotein Cholesterol (LDL-C) of an "inclisiran first" implementation strategy compared to usual care across visits.
Calculated by averaging the observed post-baseline values (percent change) for each participant across analysis visits.
Measured: Up to 330 Days
Average Absolute Change From Baseline in LDL-C Levels Across Visits
Average absolute change in Low-Density Lipoprotein Cholesterol (LDL-C) of an "inclisiran first" implementation strategy compared to usual care across visits.
Calculated by averaging the observed post-baseline values (absolute change) for each participant across analysis visits.
Measured: Up to 330 days
Percentage of Participants Achieving ≥ 50% Reduction From Baseline in LDL-C
Percentage of patients achieving a ≥ 50% reduction from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) levels of an "inclisiran first" implementation strategy compared to usual care at Day 330.
Missing data is imputed using "non-responder" (i.e., "negative" outcome) imputation.
Measured: Baseline, Day 330
Percentage of Participants Achieving LDL-C < 100 mg/dL.
Percentage of participants achieving Low-Density Lipoprotein Cholesterol (LDL-C) < 100 mg/dL (among the subset of participants with LDL-C >=100 mg/dL at baseline) of an "inclisiran first" implementation strategy compared to usual care at Day 330.
Missing data is imputed using "non-responder" (i.e., "negative" outcome) imputation.
Measured: Day 330
Percentage of Participants Achieving LDL-C < 70 mg/dL
Percentage of participants achieving Low-Density Lipoprotein Cholesterol (LDL-C) < 70 mg/dL of an "inclisiran first" implementation strategy compared to usual care at Day 330.
Missing data is imputed using "non-responder" (i.e., "negative" outcome) imputation.
Measured: Day 330
Percentage of Participants Achieving LDL-C < 55 mg/dL
Percentage of participants achieving Low-Density Lipoprotein Cholesterol (LDL-C) < 55 mg/dL of an "inclisiran first" implementation strategy compared to usual care at Day 330.
Missing data is imputed using "non-responder" (i.e., "negative" outcome) imputation.
Measured: Day 330
Percent Change in Lipids and Other Lipoproteins From Baseline
Percent change in plasma lipids, lipoproteins and triglycerides in participants receiving an "inclisiran first" implementation strategy compared to usual care at Day 330
Measured: Baseline, Day 330
Absolute Change in Lipids and Other Lipoproteins From Baseline
Absolute change in plasma lipids, lipoproteins and triglycerides in participants receiving an "inclisiran first" implementation strategy compared to usual care at Day 330
Measured: Baseline, Day 330
Percentage of Participants by Intensity of Lipid Lowering Therapy
Percentage of participants with decrease in dose, no change in dose or increase in dose to assess changes in background lipid-lowering therapy in participants receiving an "inclisiran first" implementation strategy compared to usual care at Day 330
Measured: Baseline, Day 330
Proportion of Days Covered by Medication
Proportion of days covered refers to the total number of days on either statin, ezetimibe, bempedoic acid or PCSK9 inhibiting monoclonal antibody therapies taken during the study divided by total number of study days, calculated for each participant; If a participant did not take any of the four medications then the total number of days will be assumed to be zero.
Measured: Up to 330 Days
LDL-C Measures of Variability - Standard Deviation
Visit-to-visit LDL-C variability from Day 90 until Day 330 of an "inclisiran first" implementation strategy compared to usual care. It was assessed using two measures of variability: standard deviation and coefficient of variation.
Measured: Day 90, Day 180, Day 270 and Day 330
LDL-C Measures of Variability - Coefficient of Variation
Visit-to-visit LDL-C variability from Day 90 until Day 330 of an "inclisiran first" implementation strategy compared to usual care. It was assessed using two measures of variability: standard deviation and coefficient of variation.
Measured: Day 90, Day 180, Day 270 and Day 330
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start25 Jun 2021
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, two-arm, parallel-group, open-label, multicenter clinical trial
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929249
- Sponsor's protocol ID
- CKJX839A1US02
- Acronym
- V-INITIATE
- Status last verified
- May 2025
- First submitted
- 11 Jun 2021
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Publications
Koren MJ, Rodriguez F, East C, Toth PP, Watwe V, Abbas CA, Sarwat S, Kleeman K, Kumar B, Ali Y, Jaffrani N. An "Inclisiran First" Strategy vs Usual Care in Patients With Atherosclerotic Cardiovascular Disease. J Am Coll Cardiol. 2024 May 21;83(20):1939-1952. doi: 10.1016/j.jacc.2024.03.382. Epub 2024 Apr 7.
PubMed 38593947
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Open-label Trial Comparing the Effectiveness of an "Inclisiran First" Implementation Strategy to Usual Care on LDL Cholesterol (LDL-C) in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C (≥70 mg/dL) Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)
- ClinicalTrials.gov ID
- NCT04929249
- Acronym / sponsor ID
- V-INITIATE / CKJX839A1US02
- Conditions
- Atherosclerotic Cardiovascular Disease
- Keywords
- Hyperlipidemia, Secondary Cardiovascular Prevention, Atherosclerotic Cardiovascular Disease (ASCVD), Hypercholesterolemia, Lipid lowering therapies, Inclisiran
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to assess the effectiveness of an "inclisiran first" implementation strategy (addition of inclisiran to maximally tolerated statin therapy immediately upon failure to achieve acceptable LDL-C with maximally tolerated statin therapy alone) compared to usual care in an atherosclerotic cardiovascular disease (ASCVD) population.
Detailed description
The study design was a randomized, two-arm, parallel-group, open-label, multicenter, clinical trial comparing an "inclisiran first" implementation strategy to usual care (1:1 randomization) with established ASCVD and elevated LDL-C (or non-HDL-C) despite treatment with maximally tolerated statin therapy.
Eligible patients had established ASCVD and elevated LDL-C levels ≥ 70 mg/dL (or non-HDL-C ≥ 100 mg/dL) despite treatment with maximally tolerated statin therapy.
In the "inclisiran first" implementation strategy group post-randomization, addition of other non-statin LDL-C lowering therapies (e.g., ezetimibe or bempedoic acid, excluding PCSK9 inhibiting monoclonal antibodies) were allowed to reach acceptable LDL-C levels. In the "inclisiran first" implementation strategy group, inclisiran was administered initially at randomization, 90 days later, and six months, thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, two-arm, parallel-group, open-label, multicenter clinical trial
| Arm | Type | Receives |
|---|---|---|
| Inclisiran First | Experimental | Drug: InclisiranInclisiran sodium 300 mg 1.5 ml (equivalent to 284 mg of inclisiran) + usual care |
| Usual Care | No intervention | –Treating physicians were recommended to treat patients in accordance with the 2018 ACC/AHA guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (28 listed)
- Participants meeting any of the following criteria are not eligible for inclusion in this study.
- Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study, and/or put the participant at significant risk (according to investigator's [or delegate] judgment) if he/she participates in the clinical study
- An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results
- New York Heart Association (NYHA) class III or IV heart failure or last known left ventricular ejection fraction <30%
- Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation at the time of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InclisiranAlso: Inclisiran FirstInclisiran sodium 300 mg/1.5 ml (equivalent to 284 mg inclisiran liquid) in prefilled syringe (PFS). | Drug | Inclisiran First |
Primary outcome
Percent Change From Baseline in LDL-C
Time frame: Baseline, Day 330
Percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) of an "inclisiran first" implementation strategy compared to usual care at Day 330.
Percentage of Participants Who Discontinued Statin Therapy
Time frame: Day 330
Percentage of patients who discontinued statin therapy ≥ 30 days before the end-of-study visit of an "inclisiran first" implementation strategy compared to usual care, for patients in the FAS excluding those with a medical history of statin intolerance.
13 secondary outcomes
Absolute Change From Baseline in LDL-C
Time frame: Baseline, Day 330
Average Percent Change From Baseline in LDL-C Levels Across Visits
Time frame: Up to 330 Days
Average Absolute Change From Baseline in LDL-C Levels Across Visits
Time frame: Up to 330 days
Percentage of Participants Achieving ≥ 50% Reduction From Baseline in LDL-C
Time frame: Baseline, Day 330
Percentage of Participants Achieving LDL-C < 100 mg/dL.
Time frame: Day 330
Percentage of Participants Achieving LDL-C < 70 mg/dL
Time frame: Day 330
Percentage of Participants Achieving LDL-C < 55 mg/dL
Time frame: Day 330
Percent Change in Lipids and Other Lipoproteins From Baseline
Time frame: Baseline, Day 330
Absolute Change in Lipids and Other Lipoproteins From Baseline
Time frame: Baseline, Day 330
Percentage of Participants by Intensity of Lipid Lowering Therapy
Time frame: Baseline, Day 330
Proportion of Days Covered by Medication
Time frame: Up to 330 Days
LDL-C Measures of Variability - Standard Deviation
Time frame: Day 90, Day 180, Day 270 and Day 330
LDL-C Measures of Variability - Coefficient of Variation
Time frame: Day 90, Day 180, Day 270 and Day 330
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38593947Koren MJ, Rodriguez F, East C, Toth PP, Watwe V, Abbas CA, Sarwat S, Kleeman K, Kumar B, Ali Y, Jaffrani N. An "Inclisiran First" Strategy vs Usual Care in Patients With Atherosclerotic Cardiovascular Disease. J Am Coll Cardiol. 2024 May 21;83(20):1939-1952. doi: 10.1016/j.jacc.2024.03.382. Epub 2024 Apr 7.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inclisiran in people with Atherosclerotic Cardiovascular Disease, run by Novartis Pharmaceuticals at 43 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in LDL-C (time frame: Baseline, Day 330). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04929249, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.