NCT04141579Completed
Functional Improvement of Coronary Artery Narrowing by Cholesterol Reduction With a PCSK9 Antibody
Functional Improvement of Non-infarcT relaTed Coronary Artery Stenosis by Extensive LDL-C Reduction With a PCSK9 Antibody
Source: ClinicalTrials.gov · Last updated 18 Jul 2024
Brief summary (registry, in English)
In a large number of patients who experienced an acute coronary syndrome, multiple narrowings of the coronary arteries are identified. Mechanical treatment of the infarct related artery is indisputable, yet mechanical treatment of other bystander lesions in non-infarct related arteries is controversial. Low-density lipoprotein cholesterol can speed up the formation of these coronary artery narrowings, and can increase the risk of a second event. The investigators want to investigate if treating patients with the new cholesterol-lowering drug evolocumab in addition to statin therapy ameliorates blood flow and reduces atherosclerotic plaque size compared with placebo. Improved blood flow and a reduction of plaque size could prevent the need for additional stenting or surgery.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 150 (actual)
- First submitted
- 22 Oct 2019
- Start date
- 10 Nov 2020
- Primary completion date
- 9 Nov 2023
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT04141579
What you commit to
- Study type: Interventional
- Participants enrolled: 150
- From 10 Nov 2020 to the primary completion date, 9 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior coronary artery bypass graft
- Contra-indication for antithrombotic therapy according to ESC guidelines
- Inability to implant a stent
- Female subjects of childbearing potential unwilling to use 1 acceptable method of effective contraception during treatment and for an additional 15 weeks after the last dose of investigational product.
- Female subject who has not used an acceptable method(s) of birth control for at least 1 month prior to screening, unless the female subject is sterilized or postmenopausal.
Other illness
- Known severe cardiac valve dysfunction that will require surgery in the follow-up period.
- Known severe liver disease defined as Child-Pugh score of 10-15.
Lab values
- Known left ventricular ejection fraction (LVEF) \< 30%
- Severe kidney disease defined as an eGFR \< 30 ml/min.
- Female subject is pregnant, breastfeeding or planning to become pregnant or planning to breastfeed during treatment and for an additional 15 weeks after the last dose of investigational product. Females of childbearing potential should only be included in the study after a confirmed menstrual period and a negative highly sensitive serum pregnancy test.
Other
- Refusal or inability to provide informed consent
- Untreated functional left main stem stenosis (FFR ≤ 0.80)
- Non-IRA stenosis not amenable for PCI treatment (operator's decision)
- Complicated IRA treatment, with one or more of the following:
- Extravasation
- Permanent no re-flow after IRA treatment (TIMI flow 0-1)
Who the study is looking for
- ACS with PCI of infarct related artery
- MVD
- FFR of non-IRA lesion 0.67 - 0.85
- 18 years old at screening
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.