drugset
drugset / Trial / NCT03734211

Cholesterol Lowering With EVOLocumab to Prevent Cardiac Allograft Vasculopathy in De-novo Heart Transplant Recipients

NCT03734211 ↗

Phase 3 Completed 130 enrolled Lars Gullestad Aarhus University Hospital · collabHelsinki University Central Hospital · collabRigshospitalet, Denmark · collabSahlgrenska University Hospital · collabSkane University Hospital · collab
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The main goal of this study is to evaluate the effect of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab on cardiac allograft vasculopathy in de novo heart transplant recipients. Secondary objectives are to assess the impact of treatment on: i) cholesterol levels, ii) renal function, iii) inflammation, iv) quality of life, v) cardiac function as assessed by biomarkers and echocardiography, vi) the number of rejections, and (vii) safety and tolerability. As an exploratory outcome, the investigators will asses the effect of treatment on clinical events (death, myocardial infarction, cerebral stroke, cancer, end stage renal disease).

Timeline

Start
2019-06-10
Primary completion
2023-05-20
Completion
2023-05-20

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Evolocumab Monoclonal antibody 420 mg Subcutaneous

Indications

No indication recorded.