deltatrials
Completed PHASE3 INTERVENTIONAL 3-arm NCT04807400

Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support (SPIRIT)

A Phase IIIb, Multicentre, Randomised Controlled Study to Evaluate the Implementation, Preference and Utility for Administration of Inclisiran Sodium in Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD-risk Equivalents and Elevated Low Density Lipoprotein Cholesterol (LDL-C) Using a Primary Care Models in the NHS.

Sponsor: Novartis Pharmaceuticals

Conditions Atherosclerotic Cardiovascular Disease Atherosclerotic Cardiovascular Disease Risk Equivelents Elevated Low Density Lipoprotein Cholesterol
Interventions Background lipid lowering therapy Behavioural Support Inclisiran
Updated 13 times since 2021 Last updated: Oct 7, 2024 Started: Jul 7, 2021 Primary completion: Jan 13, 2023 Completion: Jan 13, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04807400, this PHASE3 trial focuses on Atherosclerotic Cardiovascular Disease and Atherosclerotic Cardiovascular Disease Risk Equivelents and remains completed. Sponsored by Novartis Pharmaceuticals, it has been updated 13 times since 2021, reflecting substantial change activity. This study contributes longitudinal data to the cardiovascular research landscape.

Status Flow

~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~Jan 2022 · 4 months · monthly snapshot~Jan 2022 – ~Jul 2022 · 6 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Feb 2023 · 5 months · monthly snapshot~Feb 2023 – ~Apr 2023 · 59 days · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Apr 2024 · 11 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – present · 20 months · monthly snapshot

Change History

13 versions recorded

  1. Nov 2024 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Nov 2024 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Apr 2024 — Jul 2024 [monthly]

    Completed PHASE3

  5. May 2023 — Apr 2024 [monthly]

    Completed PHASE3

▶ Show 8 earlier versions

  1. Apr 2023 — May 2023 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  2. Feb 2023 — Apr 2023 [monthly]

    Active Not Recruiting PHASE3

  3. Sep 2022 — Feb 2023 [monthly]

    Active Not Recruiting PHASE3

  4. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  5. Jan 2022 — Jul 2022 [monthly]

    Recruiting PHASE3

  6. Sep 2021 — Jan 2022 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  7. May 2021 — Sep 2021 [monthly]

    Not Yet Recruiting PHASE3

  8. Apr 2021 — May 2021 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

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

Altrincham, United Kingdom , Chadderton, United Kingdom , Cheadle Hulme, United Kingdom , Davyhulme, United Kingdom , Didsbury, United Kingdom , Greater Manchester, United Kingdom , Lancashire, United Kingdom , Manchester, United Kingdom , Northenden, United Kingdom , Sale, United Kingdom and 2 more locations