THIS TRIAL IS NOW CLOSED
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER)
Investigator: Michael N Harris, MD
Status: Recruiting
Phase: 3
Sponsor: Amgen
Contact: Ama Haynes, 541-706-6595 or ahaynes@bmctotalcare.com
Location: Bend, Oregon (Central Oregon)
Purpose: The primary hypothesis is that additional LDL-C lowering with Evolocumab (AMG 145) when used in addition to other treatment for dyslipidemia is well tolerated and decreases the risk of cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization in subjects with clinically evident cardiovascular disease.
Inclusion Criteria:
- Male or female ≥ 40 to ≤ 85 years of age
- History of clinically evident cardiovascular disease as evidenced by ANY of the following:
- diagnosis of myocardial infarction
- diagnosis of non-hemorrhagic stroke
- symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI)<0.85, or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease
- Fasting LDL-C ≥ 70 mg/dL (≥ 1.8 mmol/L) ) or non-HDL-C ≥ 100 mg/dL (> 2.6 mmol/L)
- Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
Exclusion Criteria:
- NYHA class III or IV, or last known left ventricular ejection fraction < 30%
- Uncontrolled hypertension
- Uncontrolled or recurrent ventricular tachycardia
- Untreated hyperthyroidism or hypothyroidism
- Homozygous familial hypercholesterolemia
- LDL or plasma apheresis
See this trial at ClinicalTrials.gov
For general inquiries, please contact the BMC Research Department at research@bmctotalcare.com or 877-692-8338.
