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

NCT04087915 | Unknown DMC

• 1 other identifier: FORWARD
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemia; High Risk Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reduction in LDL-C

  up to 12 months

Study Arms (1)

High risk coronary artery disease

Participants with high risk coronary artery disease.

Drug: Evolocumab

Interventions

Evolocumab DRUG

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

High risk coronary artery disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with high risk coronary artery disease

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Dyslipidemias; Hypercholesterolemia

Interventions

evolocumab

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias

Study Officials

• Yujie Zhou, PhD,MD

  Beijing Anzhen Hospital

  STUDY CHAIR

Central Study Contacts

Yujie Zhou, PhD,MD

CONTACT

8613901330652; azzyj12@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD,MD

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 12, 2019
• Study Start: September 11, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 2, 2020

Record last verified: 2020-12

Locations

CN (1)