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NCT04929249 · ClinicalTrials.gov registry record · Phase 3
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, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
NCT04929249: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT04929249 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 450 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04929249, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
Study 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 cardiovascular disease (ASCVD) population.
Primary Outcome
Percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) of an "inclisiran first" implementation strategy compared to usual care at Day 330.
Interventions
- DRUG Inclisiran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2021-06-25 |
| Est. Completion | 2023-09-15 |
| Phase | Phase 3 |
What the finished NCT04929249 record still lists
NCT04929249 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 1 intervention - of which Inclisiran is the first listed.
NCT04929249 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04929249 about?
NCT04929249 is a clinical study titled "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)". 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 at...
What is the current status of trial NCT04929249?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2021-06-25. Estimated completion is 2023-09-15.
What interventions are being tested in trial NCT04929249?
The interventions under investigation include: Inclisiran (DRUG).
Who is sponsoring clinical trial NCT04929249?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04929249's enrollment target sits among peer trials
450 837th of 2000 higher than 1,137 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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