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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Dyslipidemia
• Dyslipidemias
• High Risk Coronary Artery Disease
• Myocardial Ischemia

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