Cholesterol lowering in heart transplant recipients

Phase 1

• Conditions: De novo heart transplantation; MedDRA version: 20.0 Level: LLT Classification code 10066521 Term: Coronary artery disease progression System Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-16
• Last Update Posted: 10 December 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
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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 (2) 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