Apolipoprotein CIII Reduction Via Colchicine

Gout Clinical Trial

Official title:

A Translational Study to Understand the Mechanism of Apolipoprotein CIII Reduction Via Colchicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083510
• Other study ID #: 13-6293
• Secondary ID: 1UL1TR001114-01
• Status: Completed
• Phase: Phase 0
• First received: March 5, 2014
• Last updated: May 28, 2014
• Start date: February 2014
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Scripps Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

The aim of this proposal will be to show, in a translational fashion, a relationship between colchicine and reduction of factors affecting triglyceride metabolism, especially apoCIII and VLDL levels. We envision colchicine as playing a role in identifying and elucidating a new mechanism for lowering TG levels, which may have a great impact on targeting patients who have not met non-HDL goals according to Adult Treatment Panel III (ATPIII guidelines) or at risk for hypertriglyceridemia-induced pancreatitis [11]. We will accomplish this by conducting a prospective cohort clinical trial of low-dose colchicine in hypertriglyceridemic patients to assess percent (%) reduction of apoCIII, VLDL, and TG. Secondary endpoints will be to observe the effects of colchicine on apoA, apoB, HDL, low-density lipoprotein (LDL), and total cholesterol (TC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Gout
• Hypertriglyceridemia
• Pericarditis

Intervention

Drug:
• Colchicine

Locations

Country	Name	City	State
United States	Scripps Translational Science Institute	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in ApoCIII levels		6 weeks	No
Primary	Reduction of triglycerides and very low density lipoprotein (VLDL) levels		6 weeks	No
Secondary	Measurement of Apolipoprotein A and Apolipoprotein B via Vertical Auto Profile (VAP)		6 weeks	No