EUCTR2017-005097-19-FI
Active, not recruiting
Phase 1
Cholesterol lowering with EVOLocumab to prevent cardiac allograft Vasculopathy in De-novo heart transplant recipients - EVOLVD
Oslo University Hospital0 sites130 target enrollmentFebruary 21, 2019
ConditionsCardiac allograft vasculopathy in de-novo heart transplant recipientsTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsRepatha
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cardiac allograft vasculopathy in de-novo heart transplant recipients
- Sponsor
- Oslo University Hospital
- Enrollment
- 130
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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