Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol
NCT ID: NCT03400800
Last Updated: 2020-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1617 participants
INTERVENTIONAL
2017-11-01
2019-08-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Inclisiran
Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 milliliters (mL) will be administered as a SC injection on Day 1, Day 90, and then every 6 months.
Inclisiran Sodium
Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
Saline Solution
Placebo (1.5 mL) will be administered as a SC injection of saline solution on Day 1, Day 90, and then every 6 months.
Placebo
Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).
Interventions
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Inclisiran Sodium
Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
Placebo
Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. History of ASCVD (coronary heart disease \[CHD\], cardiovascular disease \[CVD\], or peripheral arterial disease \[PAD\]).
3. Serum LDL-C ≥1.8 millimole (mmol)/liter (L) (≥70 mg/dL).
4. Fasting triglyceride \<4.52 mmol/L (\<400 mg/dL) at screening.
5. Calculated glomerular filtration rate \>30 mL/min by estimated glomerular filtration rate (eGFR) using standardized clinical methodology
6. Participants on statins should be receiving a maximally tolerated dose.
7. Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins.
8. Subjects on lipid-lower therapies (such as a statin and/or ezetimibe) should be on a stable dose for ≥30 days before screening with no planned medication or dose change during study participation.
9. Subjects were willing and able to give informed consent before initiation of any study-related procedures and willing to comply with all required study procedures
Exclusion Criteria
2. Uncontrolled cardiac arrhythmia.
3. Uncontrolled severe hypertension.
4. Active liver disease.
5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (for example, combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion:
1. Women \>2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age.
2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.
3. Women who are surgically sterilized at least 3 months prior to enrollment.
6. Males who are unwilling to use an acceptable method of birth control during the entire study period (such as condom with spermicide).
7. Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.
8. Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
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The Medicines Company
INDUSTRY
Responsible Party
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Principal Investigators
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Ray Kausik, MD
Role: PRINCIPAL_INVESTIGATOR
Imperial College of London
Locations
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Research Site 11420-002
Chomutov, , Czechia
Research Site 11420-003
Uherské Hradiště, , Czechia
Research Site 11049-006
Berlin, , Germany
Research Site 11049-002
Bochum, , Germany
Research Site 11049-003
Frankfurt, , Germany
Research Site 11049-007
Heidelberg, , Germany
Research Site 11049-001
Leipzig, , Germany
Research Site 11036-001
Budapest, , Hungary
Research Site 11036-004
Debrecen, , Hungary
Research Site 11036-002
Hatvan, , Hungary
Research Site 11036-003
Zalaegerszeg, , Hungary
Research Site 11048-018
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Research Site 11048-016
Brzozów, Podkarpackie Voivodeship, Poland
Research Site 11048-019
Ruda Śląska, Silesian Voivodeship, Poland
Research Site 11048-011
Bydgoszcz, , Poland
Research Site 11048-004
Gdansk, , Poland
Research Site 11048-017
Gdansk, , Poland
Research Site 11048-005
Gdynia, , Poland
Research Site 11048-007
Katowice, , Poland
Research Site 11048-012
Katowice, , Poland
Research Site 11048-014
Krakow, , Poland
Research Site 11048-003
Krakow, , Poland
Research Site 11048-008
Lublin, , Poland
Research Site 11048-001
Poznan, , Poland
Research Site 11048-013
Rzeszów, , Poland
Research Site 11048-015
Tarnów, , Poland
Research Site 11048-009
Warsaw, , Poland
Research Site 11048-006
Warszawice, , Poland
Research Site 11048-002
Wroclaw, , Poland
Research Site 11048-010
Wroclaw, , Poland
Research Site 11027-003
Bloemfontein, Free State, South Africa
Research Site 11027-005
Johannesburg, Gauteng, South Africa
Research Site 11027-001
Cape Town, Western Cape, South Africa
Research Site 11027-013
Cape Town, Western Cape, South Africa
Research Site 11027-007
Kuils River, Western Cape, South Africa
Research Site 11027-004
Somerset West, Western Cape, South Africa
Research Site 11027-006
Pretoria, , South Africa
Research Site 11027-011
Welkom, , South Africa
Research Site - 11380-005
Cherkasy, , Ukraine
Research Site - 11380-008
Kharkiv, , Ukraine
Research Site - 11380-004
Kiev, , Ukraine
Research Site - 11380-009
Kiev, , Ukraine
Research Site - 11380-001
Kyiv, , Ukraine
Research Site - 11380-002
Kyiv, , Ukraine
Research Site - 11380-003
Kyiv, , Ukraine
Research Site - 11380-007
Lviv, , Ukraine
Research Site - 11380-006
Uzhhorod, , Ukraine
Research Site - 11044-006
Edgbaston, Birmingham, United Kingdom
Research Site - 11044-022
Sale, Cheshire, United Kingdom
Research Site - 11044-023
Sale, Cheshire, United Kingdom
Research Site - 11044-021
Timperley, Cheshire, United Kingdom
Research Site - 11044-012
Liskeard, Cornwall, United Kingdom
Research Site - 11044-009
Exeter, Devon, United Kingdom
Research Site - 11044-019
Plymouth, Devon, United Kingdom
Research Site - 11044-014
Chorley, Lancashire, United Kingdom
Research Site - 11044-004
Waterloo, Liverpool, United Kingdom
Research Site - 11044-027
Davyhulme, Manchester, United Kingdom
Research Site - 11044-028
Bollington, , United Kingdom
Research Site - 11044-026
Bury, , United Kingdom
Research Site - 11044-007
Cardiff, , United Kingdom
Research Site - 11044-024
Cheadle Hulme, , United Kingdom
Research Site - 11044-010
Derby, , United Kingdom
Research Site - 11044-001
Glasgow, , United Kingdom
Research Site - 11044-008
Hexham, , United Kingdom
Research Site - 11044-020
Macclesfield, , United Kingdom
Research Site - 11044-025
Manchester, , United Kingdom
Research Site - 11044-005
Manchester, , United Kingdom
Research Site - 11044-029
Manchester, , United Kingdom
Research Site - 11044-003
Reading, , United Kingdom
Research Site - 11044-002
Stockton, , United Kingdom
Countries
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References
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Wright RS, Ray KK, Landmesser U, Koenig W, Raal FJ, Leiter LA, Conde LG, Han J, Schwartz GG. Effects of Inclisiran in Patients With Atherosclerotic Cardiovascular Disease: A Pooled Analysis of the ORION-10 and ORION-11 Randomized Trials. Mayo Clin Proc. 2024 Jul 5:S0025-6196(24)00167-8. doi: 10.1016/j.mayocp.2024.03.025. Online ahead of print.
Dutta S, Shah R, Singhal S, Singh S, Piparva K, Katoch CDS. A systematic review and meta-analysis of tolerability, cardiac safety and efficacy of inclisiran for the therapy of hyperlipidemic patients. Expert Opin Drug Saf. 2024 Feb;23(2):187-198. doi: 10.1080/14740338.2023.2293201. Epub 2023 Dec 19.
Ray KK, Wright RS. Plain language summary of results from ORION-10 and ORION-11: two studies to learn how well inclisiran works in people with high cholesterol. Future Cardiol. 2023 Mar;19(4):175-184. doi: 10.2217/fca-2022-0133. Epub 2023 Jun 6.
Ray KK, Wright RS, Kallend D, Koenig W, Leiter LA, Raal FJ, Bisch JA, Richardson T, Jaros M, Wijngaard PLJ, Kastelein JJP; ORION-10 and ORION-11 Investigators. Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol. N Engl J Med. 2020 Apr 16;382(16):1507-1519. doi: 10.1056/NEJMoa1912387. Epub 2020 Mar 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MDCO-PCS-17-08
Identifier Type: -
Identifier Source: org_study_id
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