Study assessing impact of additional reduction of bad cholesterol on heart related diseases with AMG 145 when used in combination with cholesterol lowering medications

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When evolocumab is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease - FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/01/004324

Enrollment

27500

Registered

2014-01-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Dyslipidemia Health Condition 2: I519- Heart disease, unspecified

Interventions

Intervention1: Evolocumab (AMG 145) and Effective statin therapy: Experimental: Arm 1 Evolocumab (AMG 145) will be administered at 1 of 2 regimens: Q2W (1 prefilled AI/Pen injection) or QM (3 prefille

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female >= 40 to 2. History of clinically evident cardiovascular disease at high risk for a recurrent event 3. Fasting LDL-C >= 70 mg/dL (>= 1.8 mmol/L) ) or non-HDL-C >= 100 mg/dL ( > 2.6 mmol/L) 4. Fasting triglycerides

Exclusion criteria

Exclusion criteria: 1. NYHA class III or IV, or last known left ventricular ejection fraction less than 30% 2. Uncontrolled hypertension 3. Uncontrolled or recurrent ventricular tachycardia 4. Untreated hyperthyroidism or hypothyroidism 5. Homozygous familial hypercholesterolemia 6. LDL or plasma apheresis

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization, whichever occurs first. (Note: The primary endpoint includes all adjudicated strokes, ischemic and hemorrhagic.)Timepoint: The study is event driven and will conclude when at least 1630 subjects have experienced an event adjudicated as qualifying for the key secondary endpoint	—

Measure

Time frame

The primary endpoint is the time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization, whichever occurs first. (Note: The primary endpoint includes all adjudicated strokes, ischemic and hemorrhagic.)Timepoint: The study is event driven and will conclude when at least 1630 subjects have experienced an event adjudicated as qualifying for the key secondary endpoint

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Secondary

Measure	Time frame
â?¢ time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first Other secondary endpoints are: â?¢ time to cardiovascular death â?¢ time to death by any cause â?¢ time to first myocardial infarction â?¢ time to first stroke â?¢ time to first coronary revascularization â?¢ time to cardiovascular death or first hospitalization for worsening heart failure, whichever occurs first â?¢ time to ischemic fatal or non-fatal stroke or TIA, whichever occurs firstTimepoint: The study is event driven and will conclude when at least 1630 subjects have experienced an event adjudicated as qualifying for the key secondary endpoint	—

Measure

Time frame

â?¢ time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first Other secondary endpoints are: â?¢ time to cardiovascular death â?¢ time to death by any cause â?¢ time to first myocardial infarction â?¢ time to first stroke â?¢ time to first coronary revascularization â?¢ time to cardiovascular death or first hospitalization for worsening heart failure, whichever occurs first â?¢ time to ischemic fatal or non-fatal stroke or TIA, whichever occurs firstTimepoint: The study is event driven and will conclude when at least 1630 subjects have experienced an event adjudicated as qualifying for the key secondary endpoint

—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Democratic People's Republic of Korea, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States of America

Contacts

Public ContactDr Veena Jaguste

Amgen Technology Pvt Ltd

psagar@amgen.com91-22-67869351

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026