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)
Public ClinicalTrials.gov record NCT04929249. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04929249
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 450 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 25, 2021 (Actual)
- Primary completion
- Sep 15, 2023 (Actual)
- Completion
- Sep 15, 2023 (Actual)
- Last update posted
- May 16, 2025
2021 – 2023
United States locations
- U.S. sites
- 43
- U.S. states
- 18
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 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 | — |
| d-b-a Greenwich Cardio Assoc CLCZ696BUS08 | Greenwich | Connecticut | 06830 | — |
| Cardiology Ass of Fairfield County . | Stamford | Connecticut | 06905 | — |
| Integrative Research Associates Inc | Fort Lauderdale | Florida | 33312 | — |
| Elite Cardiac Research Center . | Hialeah | Florida | 33012 | — |
| University of Florida Health Science Center . | Jacksonville | Florida | 32209 | — |
| Jacksonville Ctr for Clin Rea Encore Research Group | Jacksonville | Florida | 32216 | — |
| Internal Medicine and Cardiology | Kissimmee | Florida | 34741 | — |
| Gateway Cardiology PC CACZ885M2301_Younis | Jerseyville | Illinois | 62052 | — |
| Affinity Health Corp | Oak Brook | Illinois | 60523 | — |
| Northwestern Medicine Northwestern University . | Winfield | Illinois | 60190 | — |
| Indiana University Health | Indianapolis | Indiana | 46202 | — |
| St Elizabeth Healthcare . | Edgewood | Kentucky | 41017 | — |
| Alexandria Cardiology Clinic . | Alexandria | Louisiana | 71301 | — |
| Medstar Health Research Institute . | Baltimore | Maryland | 21218 | — |
| MedStar Good Samaritan Hospital | Baltimore | Maryland | 21239 | — |
| Bryan LGH Heart Inst Intigrated Cardiology Group . | Lincoln | Nebraska | 68506 | — |
| Inspira Health Network The Heart House | Elmer | New Jersey | 08318 | — |
| New Jersey Heart | Linden | New Jersey | 07036 | — |
| New York Presbyterian Queens . | Flushing | New York | 11355 | — |
| New York Presbyterian Hospital . | New York | New York | 10021 | — |
| State Uni of NY at Stony Brook . | Stony Brook | New York | 11794-3362 | — |
| Montefiore Hospital . | The Bronx | New York | 10467 2490 | — |
| Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Capital Area Research LLC Suite 330 | Newport | Pennsylvania | 17074 | — |
| Capital Area Research | Newport | Pennsylvania | 17074 | — |
| Cardiology Consultants of Philadelphia | Yardley | Pennsylvania | 19067 | — |
| Alliance for Multispecialty Res LLC | Nashville | Tennessee | 37203 | — |
| Cypress Heart and Vascular Center | Cypress | Texas | 77429 | — |
| NW Houston Neuro Comp Sleep Med Ctr | Cypress | Texas | 77429 | — |
| 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 | — |
| Synergy Groups Medical LLC | Missouri City | Texas | 77459 | — |
| Bay Area Heart Ace Clinical Resh Gp . | Webster | Texas | 77598 | — |
| Centra Health . | Lynchburg | Virginia | 24501 | — |
| National Clinical Research . | Richmond | Virginia | 23294 | — |
| Exemplar Research Inc . | Morgantown | West Virginia | 26501 | — |
| Marshfield Medical Clinic . | Marshfield | Wisconsin | 54449 | — |
| Marshfield Clinic Health System | Weston | Wisconsin | 54476 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04929249, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 16, 2025 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04929249 live on ClinicalTrials.gov.