Table 1 CARMELINA® inclusion criteria
High risk of vascular events (I and/or II) | ||
I. | Albuminuria (UACR ≥ 30 mg/g or ≥ 30 μg albumin/min or ≥ 30 mg albumin/24 h in two out of three unrelated spot urine or timed samples in the 24 months prior to randomization) and previous macrovascular disease, defined as one or more of the following | |
(a) | Confirmed history of myocardial infarction (> 2 months prior to screening) | |
(b) | Advanced coronary artery disease, defined by any one of the following | |
≥ 50% narrowing of the luminal diameter in 2 or more major coronary arteries (left anterior descending, circumflex, right coronary artery) by coronary angiography, MRI angiography or CT angiography | ||
Left main stem coronary artery with ≥ 50% narrowing of the luminal diameter by coronary angiography, MRI angiography or CT angiography | ||
Prior percutaneous or surgical revascularization of ≥ 2 major coronary arteries ≥ 2 months prior to screening | ||
The combination of prior percutaneous or surgical revascularization of 1 major coronary artery ≥ 2 months prior to screening, and ≥ 50% narrowing of the luminal diameter by coronary angiography, MRI angiography or CT angiography of at least 1 additional major coronary artery | ||
(c) | High-risk single-vessel coronary artery disease, defined as the presence of ≥ 50% narrowing of the luminal diameter of one major coronary artery by coronary angiography, MRI angiography or CT angiography in patients not revascularized and at least one of the following | |
A positive non-invasive stress test, confirmed by either | ||
A positive ECG exercise tolerance test in patients without left bundle branch block, Wolff–Parkinson–White syndrome, left ventricular hypertrophy with repolarization abnormality, or paced ventricular rhythm, atrial fibrillation in case of abnormal ST-T segments | ||
A positive stress echocardiogram showing induced regional systolic wall motion abnormalities | ||
A positive nuclear myocardial perfusion imaging stress test showing stress-induced reversible perfusion abnormality | ||
A positive cardiac stress perfusion MRI showing a stress-induced perfusion defect | ||
Patient discharged from hospital with a documented diagnosis of unstable angina pectoris between 2 and 12 months prior to screening | ||
(d) | History of ischemic or hemorrhagic stroke (> 3 months prior to screening) | |
(e) | Presence of carotid artery disease (symptomatic or not) documented by either | |
Imaging techniques with at least one lesion estimated to be ≥ 50% narrowing of the luminal diameter | ||
Prior percutaneous or surgical carotid revascularization | ||
(f) | Presence of peripheral artery disease documented by either | |
Previous limb angioplasty, stenting or bypass surgery | ||
Previous limb or foot amputation due to macrocirculatory insufficiency | ||
Angiographic evidence of peripheral artery stenosis ≥ 50% narrowing of the luminal diameter in at least one limb (definition of peripheral artery: common iliac artery, internal iliac artery, external iliac artery, femoral artery, popliteal artery) | ||
II | Impaired renal function with/without CV comorbidities | |
eGFR (MDRD) of 15 to < 45 mL/min/1.73 m2 at screening | ||
eGFR (MDRD) ≥ 45 to 75 mL/min/1.73 m2 at screening with UACR > 200 mg/g or > 200 μg albumin/min or > 200 mg albumin/24 h in two out of three unrelated spot urine or timed samples in the 24 months prior to randomization | ||