Cardiovascular Clinical Research Study for Elevated Lipoprotein(a)

Who’s eligible?

Patients* aged 50 years or older.
Lp(a) ≥ 200 nmol/L during Lp(a) screening by a central laboratory using an investigational IVD test.

>> At least 4 weeks of stable and optimized lipid-lowering therapy consistent with regional/local clinical practice guidelines or according to investigators’ judgment before Lp(a) screening.

Participants meeting at least one of the following categories (A or B):

A. Multiple risk factors for atherosclerotic disease:

1.) Presence of ≥ 4 of any of the following ASCVD risk factors:
a. Age ≥ 65 years men or women
b. History of hypertension requiring pharmacotherapy
c. Current cigarette tobacco smoking
d. Diabetes mellitus (Type 1 or Type 2) requiring pharmacotherapy
e. Screening high-sensitivity C-reactive protein (hs-CRP) ≥ 2.0 mg/L by central laboratory
f. Screening estimated glomerular filtration rate (eGFR) 30 to< 60 ml/min/1.73 m2 by central laboratory
g. Familial hypercholesterolemia or family history of premature ASCVD (1st degree relative before age 55 years for males, and/or 1st degree relative before age 65 years for females)

AND/OR

B. History of atherosclerosis evidenced by:

1.) Coronary Artery Disease-Reporting and Data System (CAD-RADS) P3, and/or
2.) Coronary artery calcium (CAC) > 300, and/or
3.) Atherosclerosis defined by at least one of the following AND ≥ 2 additional risk factors listed in A:
a. Coronary atherosclerosis as evidenced by a stenosis ≥ 50% in at least one artery
b. Coronary atherosclerosis as evidenced by a stenosis ≥ 25% ( or reported as at least mild) in at least 2 arteries detected on invasive or noninvasive imaging
c. Coronary atherosclerosis as evidenced by a CAC score > 100 and/or CAD-RADS ≥ P2
d. Carotid atherosclerosis as evidenced by an internal carotid stenosis ≥ 50%
e. Peripheral atherosclerosis as evidenced by ≥ 50% stenosis of limb artery and/or ankle brachial index < 0.9

No history of heart attack, stroke, transit ischemic attack, or acute limb ischemia.
No history of arterial revascularization surgery.
No major bleeding disorders.
No active cancer diagnosis. Must be in remission for at least 5 years (excluding non-melanoma skin cancers).
At least 5.5 years of commitment with regular office visits every 3 months.
Patient reimbursed for time and participation.

If you are eligible and enroll, you will receive all study-related care at no cost. You will also receive monitoring by a research doctor.

*WWMG patients are welcome to apply. Patients seen outside of WWMG are accepted, however we will need medical records from your treating physician.

For additional details or if you have questions, please call (425) 225-2780 or email clinicalresearch@wwmedgroup.com.