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NCT04087915 Clinical Trial

Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With High Risk Coronary Artery Disease (FORWARD)

Dyslipidemia Clinical Trial

— FORWARD  

Official title:
A Perspective, Cohort 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 High Risk Cardiovascular Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04087915
Other study ID # FORWARD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 11, 2019
Est. completion date December 31, 2021

Study information
Verified date December 2020
Source Beijing Anzhen Hospital
Contact Yujie Zhou, PhD,MD
Phone 8613901330652
Email azzyj12@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 revascularization, whichever occurs first, in patients with high risk coronary artery disease.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Evolocumab
Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference

Locations
Country Name City State
China Beijing Anzhen Hospital, Capital Medical University Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE) MACCE will include all-cause death, cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization 1 year
Secondary Reduction in LDL-C Reduction in LDL-C reduction in LDL-C after 1 month, 3 months, 6 months and 12 months of therapy up to 12 months
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