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New treatment option for Stable Coronary Disease
Official title The Impact of Pcsk-9 Inhibition on PET CFR in Patients at High CV Risk
ClinicalTrials.gov ID: NCT05152888
What this study is testing
What is Evolocumab?
Evolocumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for stable coronary disease.
Also referred to as Repatha.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study protocol is a single-arm, open label pilot study designed to evaluate the impact of PCSK-9 inhibition on coronary blood flow in patients with stable coronary artery disease. Patients with stable coronary artery disease will be recruited from the BWH Cardiovascular Medicine clinic and/or from the BWH Nuclear Cardiology Laboratory.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 90
You may be able to join if
- Intervention Group:
- Age: ≥ 50 (men) or ≥ 55 (women)
- Low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL
- Stable coronary artery disease (without plan to undergo revascularization before randomization) defined as one or more of the following:
- Abnormal nuclear perfusion imaging
You likely can't join if
- History of myocardial infarction or stroke
- CABG \< 3 months prior to screening
- Homozygous familial hypercholesterolemia
- History of cardiac transplantation
- LV ejection fraction \< 40% or New York Heart Failure Association (NYHA) class III-IV for angina and/or dyspnea.
- History of infiltrative or hypertrophic cardiomyopathy
See the full eligibility criteria
- Intervention Group:
- Age: ≥ 50 (men) or ≥ 55 (women)
- Low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL
- Stable coronary artery disease (without plan to undergo revascularization before randomization) defined as one or more of the following:
- Abnormal nuclear perfusion imaging
- At least moderate ischemia involving \>10% of the LV myocardium or
- Global coronary flow reserve (CFR) \<1.8 or
- Stress myocardial blood flow (MBF) \<1.8
- Abnormal coronary angiography (invasive coronary angiography or coronary computed tomography)
- ≥ 50% stenosis in ≥ 2 coronary vessels or
- Diffuse atherosclerosis in a 3-vessel distribution
- Elevated coronary calcium score
- CAC \>100 + \>1 ASCVD risk factor
- CAC \>300
- If the patient is on a statin they must be on a stable dose for at least 3 months prior to enrollment.
- History of myocardial infarction or stroke
- CABG \< 3 months prior to screening
- Homozygous familial hypercholesterolemia
- History of cardiac transplantation
- LV ejection fraction \< 40% or New York Heart Failure Association (NYHA) class III-IV for angina and/or dyspnea.
- History of infiltrative or hypertrophic cardiomyopathy
- Severe valvular disease
- Uncontrolled or recurrent ventricular tachycardia
- Fasting triglycerides \> 500 mg/dL
- GFR ˂ 30 mL/min/1.73 m²
- Current use of a PCSK-9 inhibitor
- Currently pregnant or breastfeeding
- Contraindication to receive vasodilator agent
- Latex allergy Parallel Control Group: Patients will be invited to participate in the parallel control group if they meet study criteria, but 1) have a latex allergy and cannot use the Evolocumab autoinjector 2) LDL-C is...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
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, 50 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.