Status:
UNKNOWN
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With High Risk Coronary Artery Disease (FORWARD)
Lead Sponsor:
Beijing Anzhen Hospital
Conditions:
Dyslipidemia
High Risk Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective was to evaluate the effect of treatment with evolocumab on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary reva...
Eligibility Criteria
Inclusion
- Male or female ≥ 18 years of age
- Coronary artery disease at high risk (Syntax Score ≥ 33)
- Patients had to have a fasting LDL cholesterol level of 1.4 mmol per liter while they had been taken an optimized regimen of lipid-lowering therapy for at least 4 weeks, which was defined as preferably a high intensity statin but must have been at least atorvastatin at a dose of 20 mg daily or its equivalent, with or without ezetimibe.
Exclusion
- New York Heart Association (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
Key Trial Info
Start Date :
September 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04087915
Start Date
September 11 2019
End Date
December 31 2021
Last Update
December 2 2020
Active Locations (1)
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1
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100029