At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 450 enrolled
Drug / intervention
Inclisirandrug
Likely dose
Inclisiran 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Inclisiran for Atherosclerotic Cardiovascular Disease. Completed, enrolled 450 participants across 43 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtherosclerotic Cardiovascular Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedJun 2021
Enrollment StartJun 2021
Primary CompletionSep 2023
TodayJul 2026
First PostedJun 18, 2021
Enrollment StartJun 25, 2021
Primary CompletionSep 15, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.0 years ago
Interventions
Inclisirandrug
Inclisiran sodium 300 mg/1.5 ml (equivalent to 284 mg inclisiran liquid) in prefilled syringe (PFS).