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Effect of impact of PCSK9 inhibitor on coronary microvascular dysfunction in patients with atherosclerotic cardiovascular disease needing coronarography.
EU CTIS ID: 2024-519012-14-00
What this study is testing
To compare coronary microvascular dysfunction (CMVD) 4-week after a single administration with evolocumab or without treatment, in patients with atherosclerotic cardiovascular disease proved by noninvasive imaging test and needing coronarography.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female patient, aged 40 to 85
- More than 50 kilograms
- LDL-C level ≥ 0.7 g / L (biological assessment of less than 6 months)
- For which coronarography is indicated according to European guidelines
- Affiliated with social security
- Signed informed consent form
You likely can't join if
- Clinical presentation of unstable angina
- Actual use of PCSK9 inhibitior (evolucumab or others)
- Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the ULN at screening
- LDL apheresis within 12 months prior to randomization
- Active infection or others active disease judge by investigator incompatible with the protocole completion
- Known sensitivity to evolocumab or their excipients to be administered during dosing or natural rubber / latex
See the full eligibility criteria
- Male or female patient, aged 40 to 85
- More than 50 kilograms
- LDL-C level ≥ 0.7 g / L (biological assessment of less than 6 months)
- For which coronarography is indicated according to European guidelines
- Affiliated with social security
- Signed informed consent form
- Clinical presentation of unstable angina
- Actual use of PCSK9 inhibitior (evolucumab or others)
- Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the ULN at screening
- LDL apheresis within 12 months prior to randomization
- Active infection or others active disease judge by investigator incompatible with the protocole completion
- Known sensitivity to evolocumab or their excipients to be administered during dosing or natural rubber / latex
- Patient likely to not be available to complete all protocol-required study visits or procedures.
- Patient in exclusion period of another study
- Woman able to procreate in the absence of highly effective contraception
- Persons referred to in Articles L1121-6 to L1121-8 of the French code of public health (this corresponds to all persons protected: pregnant or parturient women, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure)
- Patient whose state of physical or psychological health could compromise the obtaining of his informed consent and his compliance with the requirements of the protocol, with the study evaluation, procedures or completion.
- End stage disease (estimated survival of less than one year)
- Severe renal dysfunction, defined as an estimated creatinine clearance (MDRD) < 30 mL/min at screening
- Contra-indication to adenosin : hypersensitivity to active active substance or to any of the excipients, type II or III atrioventricular block or atrial disease (except for pacemaker users), long QT syndrome, severe arterial hypotension, acute heart failure, asthma and severe chronic obstructive pulmonary disease, unstable angina unstabilized by drug therapy, taking dipyridamole, aminophylline, theophylline or other xanthine base within 24 hours prior to adenosine administration
- Contra-indication to heparin: hypersensitivity to active substance or to any of the excipients, past heparin induced thrombopenia type II, haemorrhage.
- Prior CABG
- Prior myocardial infarction in the territory needing coronary microcirculation measurement
- NYHA class III or IV, or last known left ventricular ejection fraction < 30%
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.