Coronary Atherosclerosis Progression with Testosterone InterVEntion (CAPTIVE)

Phase 3

• Conditions: Coronary atheroma; Coronary atherosclerosis; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12620000100998
• Lead Sponsor: The University of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-05
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 558

Inclusion Criteria

Men aged 50-74 years
Waist circumference greater than or equal to 95 cm
No known reproductive pathology or CVD
Baseline testosterone less than or equal to 14 nmol/L
Able and willing to meet protocol requirements, read and understand the Participant Information and Consent Form and provide informed consent

Exclusion Criteria

Age greater than or equal to 75 years (to exclude older men more likely to be frail or have limited mobility)
Presence of hypothalamic, pituitary or testicular disease
Use of androgens or anti-androgen therapy within past 12 months
Known CVD (established angina, MI, heart failure, stroke, transient ischaemic attack or coronary or carotid artery revascularisation)
Previous unprovoked deep vein thrombosis or pulmonary embolism
Current anticoagulation (relative contraindication for deep intramuscular injections: use of aspirin in low-moderate dose, or fish oil, are not exclusions)
Any malignancy apart from non-melanoma skin cancer
Untreated hyper- or hypothyroidism
Diabetes mellitus requiring the use of insulin
Ongoing episode of major depression or other significant psychiatric disorder
Excessive alcohol intake (greater than or equal to 14 standard drinks/week)
Use of medications known to affect the production or action of testosterone (e.g. GnRH agonists, spironolactone, or regular opioids) or sex hormone binding globulin (e.g. insulin, growth hormone, antiepileptics, thyroid hormone)
Major systemic illnesses (e.g. HIV infection, chronic viral hepatitis)
Previous (within past 5 years) or planned bariatric surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in volume of non-calcified coronary atheromatous plaque from baseline to end of intervention period as measured by Computed Tomography Coronary Angiography (CTCA) [Two years from first study injection]

Secondary Outcome Measures

Name	Time	Method
ow attenuation plaque (<30 Hounsfield Units) assessed using CTCA[Two years from first study injection];Spotty calcification (<3mm in size) assessed using CTCA[Two years from first study injection];Napkin ring sign assessed using CTCA[Two years from first study injection];Plaque Remodelling Index (PRI) >1.10 assessed using CTCA[Two years from first study injection];Pericoronary adipose tissue attenuation assessed using CTCA[Two years from first study injection]