Multislice Computed Tomography Assessment of PCSK9 Inhibition on Coronary Perfusion
NCT ID: NCT03851263
Last Updated: 2019-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2019-08-30
2023-02-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Evolocumab
All subjects are treated with evolocumab 140mg every 2 weeks (q2w) starting on day 1 and ending on day 1071 (week 153).
Evolocumab
Subcutaneous injection, using a pre-filled auto-injector pen. Each pen contains 1.0 ml fluid (containing 140 mg evolocumab) which is injected in the abdomen, thigh or outer area of upper arm every 2 weeks (q2w).
Interventions
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Evolocumab
Subcutaneous injection, using a pre-filled auto-injector pen. Each pen contains 1.0 ml fluid (containing 140 mg evolocumab) which is injected in the abdomen, thigh or outer area of upper arm every 2 weeks (q2w).
Eligibility Criteria
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Inclusion Criteria
2. At least two of the evaluable vessels with subclinical coronary artery disease as defined non-invasively by CCTA with encroachment of the vessel and either: a. Lesion with visual diameter stenosis (DS) \< 50% or, b. Lesion with visual DS ≥ 50% and FFRCT \> 0.80;
3. No planned coronary revascularization (during the course of the study) at the time of enrollment;
4. Most recent, taken within 30 days prior to informed consent form (ICF) signature, fasting LDL-C ≥ 80 mg/dL (≥ 2.07 mmol/L) and on stable statin therapy for at least 30 days at the time of blood sampling, or statin-intolerant or for whom a statin is contraindicated.
5. Subject signed informed consent form
Exclusion Criteria
2. New York Heart Association (NYHA) class III or IV heart failure
3. Last known left ventricular ejection fraction \<30%
4. Active liver disease or hepatic dysfunction, either known or defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times the upper limit of normal (ULN)
5. Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2
6. Active malignancy except for adequately treated non-melanoma skin cancer or other non-invasive or in situ neoplasm (e.g. successfully treated cervical cancer in situ or non-active prostate cancer) Imaging CCTA-related
7. Absence of baseline CCTA obtained in the context of standard clinical care
8. Baseline CCTA not meeting Core Lab quality standards
9. Any contraindication for repeat CCTA such as known anaphylactic allergy to iodinated contrast
Concomitant and study medication
11. LDL or plasma apheresis within 12 months of screening
12. Subject \< 18 years of age
13. Legally incompetent to provide written informed consent;
14. Known pregnancy or breast-feeding at time of screening
15. Female subject of childbearing potential, i.e. who are not surgically sterile or post-menopausal (defined as no menses for 2 years without an alternative cause)
16. Male subject with female partner of childbearing potential who is not using highly effective birth control
17. Currently participating in another trial
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
GE Healthcare
INDUSTRY
HeartFlow, Inc.
INDUSTRY
ECRI bv
INDUSTRY
Responsible Party
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Principal Investigators
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Patrick W Serruys, Prof. dr.
Role: STUDY_CHAIR
NHLI Imperial College, London
Other Identifiers
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ECRI-11
Identifier Type: -
Identifier Source: org_study_id