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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04087915

Acronym

FORWARD

Enrollment

1000

Registered

2019-09-12

Start date

2019-09-11

Completion date

2021-12-31

Last updated

2020-12-02

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

Conditions

Dyslipidemia, High Risk Coronary Artery Disease

Keywords

High cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia

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.

Interventions

DRUGEvolocumab

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactYujie Zhou, PhD,MD

azzyj12@163.com8613901330652

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026