First-in-Human Abdominal Aortic Aneurysms trial with Tricaprin (F-HAAAT)

JRCT ID: jRCTs051240036

Registered date:17/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Abdominal Aortic Aneurysm
• Date of first enrollment: 21/06/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Administer Caprin HI 800 mg (2 tablets), containing 500 mg of tricaprin, three times a day after each meal (total 6 tablets/day) for two weeks. After confirming that no unpredictable intolerance symptoms have occurred by a medical examination, the dosage will be increased to Caprin HI 1600 mg (4 tablets), containing 1000 mg of tricaprin, three times a day after each meal (total 12 tablets/day) for 50 weeks (a total of 52 weeks on oral administration of Caprin HI). If a dose is missed, take two doses at the next scheduled administration time. If all doses (morning, noon, and evening) are missed, take two doses before bedtime.

Outcome(s)

Primary Outcome

Frequency of adverse events

Also, the additional analysis for (1) - (3) below will be performed.
(1) Major adverse cardiovascular events (cardiovascular deaths, non-fatal myocardial infarction, non-fatal cerebrovascular stroke)
(2) Serious abdominal aortic aneurysm-related events (persistent non-fatal acute abdominal or back pain with proven rupture, persistent non-fatal acute abdominal or back pain with unproven rupture, sudden color change in extremities with severe pain or lower extremity edema, abrupt demand for the surgical treatment, etc.)
(3) Other (investigational treatment-related adverse events that cannot be classified into (1) to (2))

Secondary Outcome

The following items related to efficacy indicators will be explored:

(1) Changes in maximum minor short-axis diameter and aneurysm volume of abdominal aortic aneurysm
(2) Analysis of the intra-aneurysmal aortic wall CT values
(3) Agatston score of abdominal aortic aneurysm (measured within the same range of the aneurysm volume measurement)

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: <= 85age 11month 4weeks old
• Gender: Both

Include criteria

(1) 50 - 85 years old patients at the time of consent
(2) Patients diagnosed with AAA whose diameter is 30 - 45mm (rounding to the nearest integer) by enhanced computed tomography
(3) Written informed consent directly by the patient

Exclude criteria

(1) History of AAA surgical repair, including endovascular treatment
(2) Patients scheduled for surgical treatment for AAA within a year
(3) Symptomatic AAA
(4) AAA location excluding the infrarenal abdominal aorta
(5) Sac-type AAA
(6) Infected AAA, or evidence of active aortitis
(7) Dissective AAA
(8) Severely calcified AAA
(9) Heart failure symptoms of New York Heart Association classification III-IV
(10) Prognosis of less than 2 years
(11) Estimated glomerular filtration rate 30 ml/min or less
(12) Bronchial asthma on treatment or diagnosed with NSAIDs-exacerbated respiratory disorder (NERD)
(13) A history of contrast agent allergy
(14) AAA associated with connective tissue diseases (Ehlers-Danlos syndrome, Marfan syndrome, Loeys-Dietz syndrome)
(15) Individuals who have been continuously consuming foods (including food oil) containing medium-chain fatty acids for more than two months and are unable to discontinue their use by the day before the initiation of Caprin HI
(16) Individuals who are unable to express their own will and manage the investigational substances on their own (e.g. dementia)
(17) Diagnosed with familial hypercholesterolemia
(18) Other patients deemed ineligible for participation by the principal investigator or co-investigator.

Related Information

• Primary Sponsor: Kamba Takahito
• Secondary Sponsor: Hirano Ken-ichi