Functional Improvement of Coronary Artery Narrowing by Cholesterol Reduction With a PCSK9 Antibody

• Status: Active, not recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

In a large number of patients who had a heart attack, multiple narrowings of the coronary arteries are identified. It is common practice to treat the narrowing that is the cause of the heart attack with a stent. It is not yet clearly known if the other narrowings in the other coronary arteries have to be treated immediately with a stent as well.

"Bad" cholesterol (LDL-cholesterol) can speed up the formation of these coronary artery narrowings, and can thus make the risk of a second heart attack bigger.

The investigators want to investigate if treating patients with the new cholesterol-lowering drug Evolocumab on top of the normal cholesterol lowering therapy (statins) ameliorates blood flow through coronary artery narrowings. Better blood flow through these narrowings could prevent the need for stenting or surgery in the future.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborator: Amgen
• Treatments: Antibodies; Antibodies, Monoclonal; Evolocumab

Criteria

Inclusion Criteria (all):

• ACS with PCI of infarct related artery

• MVD

• FFR of non-IRA lesion 0.67 - 0.80

• Subjects must have an eligible LDL-C level via local lab assessment based on statin use at screening:

• No statin use: 130 mg/dL (3.3 mmol/l)

• Non-intensive statin use: 80 mg/dL (2.0 mmol/l)

• Intensive statin use 60mg/dL (1.6 mmol/l)

• 18 years old at screening

Exclusion Criteria (any):

• Refusal or inability to provide informed consent

• Prior coronary artery bypass graft

• Known left ventricular ejection fraction (LVEF)<30%

• Left main stem stenosis >50%

• Contra-indication for dual antiplatelet therapy

• Chronic total occlusion of a non-IRA

• Non-IRA stenosis not amenable for PCI treatment (operators decision)

• Complicated infarct related artery (IRA) treatment, with one or more of the following:

• Extravasation

• Permanent no re-flow after IRA treatment (TIMI flow 0-1)

• Inability to implant a stent

• Known severe cardiac valve dysfunction that will require surgery in the follow-up period.

• Severe kidney disease defined as an estimated glomerular filtration rate (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.

• 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.