Advancing Postmenopausal Preventive Therapy

Atherosclerosis Clinical Trial

— APPT  

Official title:

Atherosclerosis Intervention With Novel Tissue Selective Estrogen Complex Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04103476
• Other study ID #: R01AG058691
• Secondary ID: R01AG058691
• Status: Recruiting
• Phase: Phase 2
• Start date: April 13, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: University of Southern California
• Contact: Lora Maxwell, RN
• Phone: (323) 442-2257
• Email: APPT[@]usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Advancing Postmenopausal Preventive Therapy (APPT) is a randomized, double-blinded, placebo-controlled trial designed to determine the effects of tissue selective estrogen complex (TSEC) therapy on the progression of subclinical atherosclerosis and cognitive decline in 360 healthy postmenopausal women.

Description:

To conduct a double-blinded, placebo-controlled trial to determine the effects of TSEC therapy on the progression of subclinical atherosclerosis in healthy postmenopausal women. A total of 360 postmenopausal women with a uterus who are within 6 years of menopause and 45-59 years of age and without clinical cardiovascular disease and diabetes mellitus will be randomized to Bazedoxifene/Conjugated Equine Estrogen (BZA 20 mg/CE 0.45 mg) or placebo. Recruitment will occur over 3 years and the treatment period will be up to 3 years depending on when an individual is randomized. Rate of change in carotid artery intima-media thickness (CIMT) determined from the distal common carotid artery (CCA) far wall intima-media thickness (IMT) in computer image processed B mode ultrasonograms will be the primary trial endpoint. Arterial stiffness measured from the CCA (same location as CIMT) in computer image processed B mode ultrasonograms will be the secondary trial endpoint. Three composite cognitive measures will be used to test for randomized treatment group differences in cognition; each composite will be considered as co-endpoints.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2026
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 59 Years

Eligibility

Inclusion Criteria:

• Women with a serum estradiol level <30 pg/ml and cessation of regular menses >6 months who are <6 years postmenopausal and 45-59 years old.

Exclusion Criteria:

• Women with a hysterectomy
• Clinical signs, symptoms or personal history of cardiovascular disease
• Diabetes mellitus or fasting serum glucose >126 mg/dL
• Life threatening illness with prognosis <5 years
• Cirrhosis or liver disease
• History of deep vein thrombosis or pulmonary embolism
• History of breast cancer
• Current use of postmenopausal hormone replacement therapy (HRT) within 1 month of randomization
• Uncontrolled hypertension (>180/>110 mmHg)*
• Plasma triglyceride levels >500 mg/dL
• Serum creatinine >2.0 mg/dL

Related Conditions & MeSH terms

• Atherosclerosis
• Cognitive Decline
• Cognitive Dysfunction

Intervention

Combination Product:
• Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg
Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	University of Southern California Atherosclerosis Research Unit	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive decline	Three composite cognitive measures will be used to test for randomized treatment group differences in cognition; each composite will be considered as co-endpoints.	At baseline and 6 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after randomization
Primary	Carotid artery intima-media thickness	Rate of change in carotid artery intima-media thickness (CIMT) determined from the distal common carotid artery (CCA) far wall intima-media thickness (IMT) in computer image processed B mode ultrasonograms.	At baseline and 6 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after randomization
Secondary	CCA stiffness	Arterial stiffness measured from the CCA (same location as CIMT) in computer image processed B mode ultrasonograms.	At baseline and 6 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after randomization