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

• Conditions: High Risk Coronary Artery Disease; Dyslipidemia
• Interventions: Drug: Evolocumab

• Registration Number: NCT04087915
• Lead Sponsor: Beijing Anzhen Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-11
• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-11
• Study First Posted: 2019-09-12
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-01
• Last Update Posted: 2020-12-02
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High risk coronary artery disease	Evolocumab	Participants with high risk coronary artery disease.

Primary Outcome Measures

Name	Time	Method
Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE)	1 year	MACCE will include all-cause death, cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization

Secondary Outcome Measures

Name	Time	Method
Reduction in LDL-C	up to 12 months	Reduction in LDL-C reduction in LDL-C after 1 month, 3 months, 6 months and 12 months of therapy

Trial Locations

Locations (1)

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China