Stanford University
Stanford, California, 94305, United States
NCT Number: NCT03537742
The focus of this study is to test the safety and efficacy of the PCSK9 inhibitor, alirocumab when administered early after heart transplantation (HT).The main objective of this project is to test the safety and impact on cardiac allograft vasculopathy (CAV) of alirocumab when given early after HT.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Stanford, California, 94305, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
alirocumab 150mg Subcutaneous
Other names: Praluent
placebo to match alirocumab
Time frame: Baseline to one year
Coronary artery plaque volume (mm³) was assessed using intravascular ultrasound (IVUS) during coronary angiography. Measurements were obtained at baseline (prior to study drug randomization) and at 1 year following treatment. The outcome measure represents the change in plaque volume from baseline to 1 year.
Time frame: Baseline and one year
Low-density lipoprotein cholesterol (LDL-C) levels were assessed at baseline and at 1 year post-randomization to compare the lipid-lowering effectiveness of adding alirocumab to standard rosuvastatin therapy versus placebo. Results are reported as mean +/- standard deviation (SD).
Time frame: Baseline and 1 year
Apolipoprotein B was measured in mg/dL at baseline and 1 year to evaluate the impact of alirocumab versus placebo on overall atherogenic particle burden.
Time frame: Baseline and 1 year
Lipoprotein(a) was measured at baseline and 1 year to assess the efficacy of alirocumab in lowering this specific lipid parameter.
Time frame: Baseline and one year
Total cholesterol was measured to assess the efficacy of alirocumab versus placebo on overall impact for this specific lipid parameter.
Time frame: Baseline and one year
HDL cholesterol was measured to assess the efficacy of alirocumab versus placebo on overall impact for this specific lipid parameter.
Time frame: Baseline and one year
Triglycerides were measured to assess the efficacy of alirocumab versus placebo on overall impact for this specific lipid parameter.
Time frame: Baseline and one year
hs-CRP was measured to assess the efficacy of alirocumab versus placebo on overall impact for this specific lipid parameter
Time frame: baseline and one year
FFR measures the exact severity of blood flow restriction in a narrowed coronary artery. It is calculated as the mean distal pressure divided by the mean proximal pressure during maximal hyperemia.
Time frame: Baseline and 1 year
CFR is the ratio of maximal coronary blood flow to resting blood flow. It was calculated as the resting mean transit time divided by the hyperemic mean transit time.
Time frame: Baseline and 1 year
IMR is used to assess the function of the coronary microvasculature. It is calculated as the hyperemic distal coronary pressure multiplied by the hyperemic mean transit time.
Time frame: Baseline and 1 year
LCBI is a measure of the lipid content within the coronary artery wall. It is calculated as the fraction of valid pixels with a yellow (high lipid probability) signal >0.6, multiplied by 1000. Values range from 0 to 1000, where higher values indicate a greater lipid burden.
Time frame: Baseline and 1 year
The maxLCBI 4-mm represents the highest lipid core burden index (LCBI) value within any contiguous 4-mm segment of the scanned coronary region, indicating the most lipid-rich portion of the plaque. Scores range from 0 to 1000. Higher scores indicate greater lipid burden (worse outcome), while lower scores indicate less lipid-rich plaque (better outcome).
Time frame: Baseline and 1 year
Measured using intravascular ultrasound (IVUS), this represents the thickness of the innermost layer of the artery wall at its thickest point.
Stanford University
Other
PCSK9 Inhibition After Heart Transplantation
Acronym: CAVIAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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