A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compar… (NCT04929249) | Clinical Trial Compass
CompletedPhase 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)
United States450 participantsStarted 2021-06-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed informed consent must be obtained prior to participation in the study
✓. Males and females ≥18 years of age
✓. History of ASCVD, documented by hospital records, claims data and/or prior laboratory/imaging assessments a Coronary heart disease (CHD):
✓. Serum LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL
✓. Fasting triglyceride \<5.65 mmol/L (\<500 mg/dL) at screening
✓. Calculated glomerular filtration rate \>30 mL/min by estimated glomerular filtration rate (eGFR) using standardized local clinical methodology
✓. Participants should be on maximally tolerated statin therapy, as determined by the investigator, with no immediate plans to modify lipid lowering therapies. Statin intolerant patients are eligible if they had documented side effects on at least 2 different statins, including one at the lowest standard dose
✓. Participants must be 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
✕. Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study, and/or put the participant at significant risk (according to investigator's \[or delegate\] judgment) if he/she participates in the clinical study
✕. An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results
What they're measuring
1
Percent Change From Baseline in LDL-C
Timeframe: Baseline, Day 330
2
Percentage of Participants Who Discontinued Statin Therapy
✕. New York Heart Association (NYHA) class III or IV heart failure or last known left ventricular ejection fraction \<30%
✕. Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation at the time of screening
✕. Major adverse cardiovascular event within 6 months prior to randomization
✕. Uncontrolled severe hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg prior to randomization despite antihypertensive therapy
✕. Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years
✕. History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the two years prior to randomization