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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


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
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