Cholesterol lowering with the drug evolocumab to prevent coronary artery disease in new heart transplants

Phase 1

• Conditions: Cardiac allograft vasculopathy in de-novo heart transplant recipients; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-005097-19-FI
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-21
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 130

Inclusion Criteria

•Heart transplant recipient within the last 4 – 8 weeks.
•Age between 18 and 70 years.
•Informed consent obtained and documented according to Good Clinical Practice (GCP), and national/regional regulations.
•No contraindications to coronary angiography with intravascular ultrasound
•Estimated glomerular filtration rate > 20 ml/min/1.73 m2 as assessed by the MDRD formula.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•Decompensated liver disease (Child-Pugh class C)
•Severe renal failure, i.e. eGFR < 20 ml/min/1.73 m2 or on renal replacement therapy
•Ongoing rejections or infections
•Known sensitivity or intolerance to evolocumab or any of the excipients of Repatha®
•Prior use of PCSK9 inhibition treatment
•Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake
•Participation in another clinical trial involving an investigational drug and/or follow-up within 30 days prior to enrolment.
•Pregnancy.
•Female subject who has either (1) not used at least one highly effective method of birth control for at least 1 month prior to screening or is not willing to use such a method during treatment and for an additional 15 weeks after the end of treatment, unless the subject is sterilised or postmenopausal

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified