Completed PHASE3 INTERVENTIONAL 2-arm NCT04929249

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) (V-INITIATE)

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)

Sponsor: Novartis Pharmaceuticals

Conditions Atherosclerotic Cardiovascular Disease

Interventions Inclisiran

Updated 19 times since 2021 Last updated: May 14, 2025 Started: Jun 25, 2021 Primary completion: Sep 15, 2023 Completion: Sep 15, 2023

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Atherosclerotic Cardiovascular Disease and is currently completed. Novartis Pharmaceuticals leads this study, which shows 19 recorded versions since 2021 — indicating substantial longitudinal coverage. Heart and vascular conditions benefit from the kind of long-term tracking this trial provides.

Status Flow

Change History

19 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Jun 2025 — Sep 2025 [monthly]

Completed PHASE3
Oct 2024 — Jun 2025 [monthly]

Completed PHASE3
Sep 2024 — Oct 2024 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3

▶ Show 14 earlier versions

Jan 2024 — Jul 2024 [monthly]

Completed PHASE3

Status: Active Not Recruiting → Completed
Aug 2023 — Jan 2024 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Feb 2023 — Aug 2023 [monthly]

Recruiting PHASE3

Status: Active Not Recruiting → Recruiting
Dec 2022 — Feb 2023 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Nov 2022 — Dec 2022 [monthly]

Recruiting PHASE3
Sep 2022 — Nov 2022 [monthly]

Recruiting PHASE3
Jul 2022 — Sep 2022 [monthly]

Recruiting PHASE3
May 2022 — Jul 2022 [monthly]

Recruiting PHASE3
Apr 2022 — May 2022 [monthly]

Recruiting PHASE3
Mar 2022 — Apr 2022 [monthly]

Recruiting PHASE3
Dec 2021 — Mar 2022 [monthly]

Recruiting PHASE3
Nov 2021 — Dec 2021 [monthly]

Recruiting PHASE3
Oct 2021 — Nov 2021 [monthly]

Recruiting PHASE3
Sep 2021 — Oct 2021 [monthly]

Recruiting PHASE3

First recorded

Jun 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Novartis Pharmaceuticals

Data source: Novartis

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Alexandria, United States , Baltimore, United States , Cypress, United States , Edgewood, United States , Elmer, United States , Flushing, United States , Fort Lauderdale, United States , Greenwich, United States , Hershey, United States , Hialeah, United States and 25 more locations