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Efficacy and safety of alirocumab to prevent early cardiac allograft vasculopathy in recent heart transplant recipients
EU CTIS ID: 2024-514023-42-00
What this study is testing
To assess the efficacy of alirocumab/placebo in lowering LDL-cholesterol in recent heart transplant recipients as an adjunct to standard background lipid lowering therapy with atorvastatin 10 mg daily. Furthermore, the impact of alirocumab on other parameters of lipid profile [total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), apolipoprotein A1 (ApoA1), apolipoprotein B (ApoB), lipoprotein a (Lp [a]), triglyceride (TG) levels] will be evaluated. The effect will be assessed in the time period between 1 and 12 months after heart transplantation.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- New cardiac transplant recipient ≥ 18 years of age willing to participate in the study.
- Ability to understand study procedures and to comply with them for the entire length of the study.
- Written informed consent obtained from subject or subject’s legal representative.
- Heart transplantation surgery performed 3-8 weeks before the baseline visit.
You likely can't join if
- Known hypersensitivity/allergy reaction to study medication.
- Complicated post-transplant outcome with poor neurological status, multiorgan failure or graft dysfunction.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Lipoprotein apheresis is planned or performed.
- Level of LDL-C ≥ 8 mmol/L at screening.
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
See the full eligibility criteria
- New cardiac transplant recipient ≥ 18 years of age willing to participate in the study.
- Ability to understand study procedures and to comply with them for the entire length of the study.
- Written informed consent obtained from subject or subject’s legal representative.
- Heart transplantation surgery performed 3-8 weeks before the baseline visit.
- Known hypersensitivity/allergy reaction to study medication.
- Complicated post-transplant outcome with poor neurological status, multiorgan failure or graft dysfunction.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Lipoprotein apheresis is planned or performed.
- Level of LDL-C ≥ 8 mmol/L at screening.
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Participation in any other interventional study.
- Known hypersensitivity/allergy to contrast agent or severe renal insufficiency (eGFR ˂ 30 ml/min/1.75 m2) exclude patient from OCT imaging only, not the whole study.
- Women with child-bearing potential will not be excluded from the trial but will be advised to use reliable contraception – which is the standard for post-transplant care.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.