Apolipoprotein CIII Reduction Via Colchicine

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this trial will be to determine an effect-size for the administration of chronic low-dose colchicine in the reduction of serum levels of triglycerides (TG), very-low density lipoproteins (VLDL), and apolipoprotein CIII (apoCIII) in human subjects over a period of 4-6 weeks.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Scripps Translational Science Institute
• Treatments: Colchicine

Criteria

Inclusion Criteria:

• Acute new-onset pericarditis or recurrent pericarditis (≥2 following criteria)

• Sharp and pleuritic chest pain improved or relieved by sitting up and leaning forward

• A pericardial friction rub

• Electrocardiogram (EKG) findings of diffuse ST-segment elevations or PR depression

• New or worsening pericardial effusion visualized on echocardiogram.

OR

•Acute gouty arthritis (according to the ACR; ≥1 of following criteria:

• Joint fluid containing urate crystals

• Tophus proved to contain urate crystals by chemical means

• Polarized light microscopy

• Presence of six of the following in the absence of crystal identification:

• >1 attack of acute arthritis

• Maximum inflammation developed in 1 day

• Monoarthritis attack

• Redness observed over joints

• 1st metatarsal joint painful or swollen

• Unilateral 1st metatarsal joint attack

• Unilateral tarsal joint attack

• Tophus (suspected)

• Hyperuricemia

• Asymmetric swelling within a joint visible on physical examination or radiography

• Subcortical cysts without erosions visible on radiography

• Monosodium urate monohydrate microcrystals in joint fluid during attack

• Joint fluid culture negative for organisms during attack.

If N < 10 after 3 weeks of trial initiation, then employ enrollment strategy #2

Enrollment strategy #2:

• History of hypertriglyceridemia (TG ≥ 150 mg/dL) AND

• Age ≥ 18 years old

• Capable of providing informed consent

• Capable of taking Colchicine 0.6-1.2 mg/day orally for 6 weeks

• Capable of providing a blood sample

Exclusion Criteria:

• Colchicine use < 8 weeks from baseline VAP panel

• Pregnant or female of child bearing age

• On corticosteroid therapy or corticosteroid use < 4 weeks from baseline VAP panel

• History of statin myopathy or hepatotoxicity

• History of colchicine intolerance or hypersensitivity

• Severe end-stage renal disease (eGFR ≤ 20 mL/min/1.73 m2) or requiring dialysis

• Hepatic Impairment (Child-Pugh class B or C)

• Myopericarditis (If TnI is elevated on presentation of acute pericarditis)

• Inflammatory Bowel Disease

• Tuberculous, neoplastic, or purulent pericarditis