Amarin Corp Plc (AMRN)

[sts66]

Here's what the trial design paper says about "established CVD" and prior events - I'll let you docs discuss whether this means "you've had an event" or not, but appears to me answer is yes - note the patient must have two or more conditions to be in risk stratum 1 (secondary prevention):

General inclusion criteria
1. Men or women age ≥45?years with established CVD (CV Risk Stratum 1; see below) OR age ≥50?years with DM in combination with 1 additional risk factor for CVD (CV Risk Stratum 2; see below)

CV Risk Stratum 1 inclusion criteria (men and women age ≥45?years with ≥1 of the following):

1. Documented CAD (≥1 of the following primary criteria must be satisfied):
a. Documented multivessel CAD (≥50% stenosis in ≥2 major epicardial coronary arteries, with or without antecedent revascularization)
b. Documented prior MI
c. Hospitalization for high-risk NSTE-ACS (with objective evidence of ischemia: ST-segment deviation or biomarker positivity)

2. Documented cerebrovascular or carotid disease (1 of the following primary criteria must be satisfied):
a. Documented prior ischemic stroke
b. Symptomatic carotid artery disease with ≥50% carotid arterial stenosis
c. Asymptomatic carotid artery disease with ≥70% carotid arterial stenosis per angiography or duplex ultrasound
d. History of carotid revascularization (catheter-based or surgical)

3. Documented PAD (≥1 of the following primary criteria must be satisfied):
a. ABI <0.9 with symptoms of intermittent claudication
b. History of aortoiliac or peripheral arterial intervention (catheter-based or surgical)

Inclusion criteria for the primary prevention group, risk stratum 2 - note no CVE's are listed:

CV Risk Stratum 2 inclusion criteria (patients with the following):

1. DM (type 1 or type 2) requiring treatment with medication AND

2. Men and women age ≥50?years AND

3. One of the following at Visit 1 (additional risk factor for CVD):
a. Men ≥55?years of age and women ≥65?years of age
b. Cigarette smoker or stopped smoking within 3 months before Visit 1
c. HTN (BP ≥140?mm Hg systolic OR ≥90?mm Hg diastolic) or on antihypertensive medication
d. HDL-C ≤40?mg/dL for men or ≤50?mg/dL for women
e. hsCRP >3.00?mg/L (0.3?mg/dL)
f. Renal dysfunction: CrCl >30 and <60?mL/min
g. Retinopathy, defined as any of the following: nonproliferative retinopathy, preproliferative retinopathy, proliferative retinopathy, maculopathy, advanced diabetic eye disease, or a history of photocoagulation
h. Micro- or macroalbuminuria. Microalbuminuria is defined as either a positive micral or other strip test (may be obtained from medical records), an albumin/Cr ratio ≥2.5?mg/mmol, or an albumin excretion rate on timed collection ≥20?mg/min all on ≥2 successive occasions. Macroalbuminuria is defined as Albustix or other dipstick evidence of gross proteinuria, an albumin/Cr ratio ≥25?mg/mmol, or an albumin excretion rate on timed collection ≥200?mg/min all on ≥2 successive occasions.
i. ABI <0.9 without symptoms of intermittent claudication (patients with ABI <0.9 with symptoms of intermittent claudication are counted under CV Risk Stratum 1)