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

NCT ID: NCT04087915

Last Updated: 2020-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-11

Study Completion Date

2021-12-31

Brief Summary

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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

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Conditions

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Dyslipidemia High Risk Coronary Artery Disease

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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High risk coronary artery disease

Participants with high risk coronary artery disease.

Evolocumab

Intervention Type DRUG

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

Interventions

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Evolocumab

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yujie Zhou

PhD,MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yujie Zhou, PhD,MD

Role: STUDY_CHAIR

Beijing Anzhen Hospital

Locations

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Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yujie Zhou, PhD,MD

Role: CONTACT

Phone: 8613901330652

Email: [email protected]

Facility Contacts

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Yujie Zhou, PhD,MD

Role: primary

Other Identifiers

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FORWARD

Identifier Type: -

Identifier Source: org_study_id