Impact of PCSK9 Inhibitors on Coronary Microvascular Dysfunction in Patients With Atherosclerotic Cardiovascular Disease Proved by Myocardial Ischemia and Needing Coronarography (MICROPROTECT)

  • days left to enroll
  • participants needed
  • sponsor
    University Hospital, Grenoble
Updated on 6 June 2022


Proprotein convertase subtilisin/kexin type 9 inhibitor monoclonal antibodies (anti-PCSK9) significantly reduce the serum LDL-C level, leading to a regression of the coronary epicardial plaque demonstrated by intracoronary ultrasonography (IVUS), as well as cardiovascular events (CV) in patients with atherosclerotic CV disease treated with statin. The impact of PCSK9 inhibition on coronary microcirculation has never been assessed. However, microvascular coronary dysfunction (CMVD) is a powerful prognostic marker, irrespective of conventional CV risk factors, but also of the severity of the epicardial coronary involvement detected during coronary angiography. The investigators hypothesized that anti-PCSK9 would decrease CMVD, measured by the microcirculatory resistance index (MRI) during coronary angioplasty (Percutaneous coronary intervention, PCI) in patients with myocardial ischemia proved in myocardial scintigraphy.

Condition Atherosclerotic Cardiovascular Disease
Treatment Evolocumab 140 MG/ML [Repatha]
Clinical Study IdentifierNCT04338165
SponsorUniversity Hospital, Grenoble
Last Modified on6 June 2022


Yes No Not Sure

Inclusion Criteria

Male or female patient, aged 40 to 85
More than 50 kilograms
Defined at high cardiovascular risk according to European guidelines
LDL-C level ≥ 0.7 g / L (biological assessment of less than 6 months)
Having benefited from myocardial scintigraphy
For which coronarography is indicated according to European guidelines
Affiliated with social security
Signed informed consent form

Exclusion Criteria

Clinical presentation of unstable angina
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 Coronary Artery Bypass Graft Surgery (CABG)
Prior myocardial infarction in the territory of ischemia
New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction < 30%
Known hemorrhagic stroke at any time
Uncontrolled or recurrent ventricular tachycardia
Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) > 180 mmHg or diastolic BP (DBP) > 110 mmHg
Actual use of PCSK9 inhibitor (evolocumab or others)
Untreated or inadequately treated hyperthyroidism or hypothyroidism, controlled by biological assessment if needed, defined by thyroid stimulating hormone (TSH) < lower limit of normal (LLN) or > 1.5 times the upper limit of normal (ULN), respectively, and free thyroxine (T4) levels that are outside normal range at screening
Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the ULN at screening
Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow, renal)
Personal or family history of hereditary muscular disorders
LDL apheresis within 12 months prior to randomization
Creatinine Phosphokinase (CPK) > 5 ULN at screening
Active infection or others active disease judge by investigator incompatible with the protocol completion
Main known active infection including positive viral serology (Human Immunodeficiency Virus, Hepatitis B Virus and Hepatitis C Virus)
Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 10 years
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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note