Apolipoprotein CIII Reduction Via Colchicine

NCT ID: NCT02083510

Last Updated: 2014-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-05-31

Brief 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.

Detailed 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).

Conditions

Hypertriglyceridemia; Gout; Pericarditis

Keywords

Colchicine; Hypertriglyceridemia; Apolipoprotein CIII

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Colchicine

Patients will be enrolled with either gout/pericarditis or hypertriglyceridemia, have VAP and Apolipoprotein CIII levels at baseline, administer Colchicine for 6 weeks with reassessment of Apolipoprotein CIII and VAP.

Group Type: EXPERIMENTAL

Colchicine

Intervention Type: DRUG

Interventions

Colchicine

Intervention Type: DRUG

Other Intervention Names

Colcrys

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Scripps Translational Science Institute

OTHER

Sponsor Role: lead

Responsible Party

Peter G. Schultz, PhD

Prinicpal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Schultz, PhD

Role: PRINCIPAL_INVESTIGATOR

Scripps Translational Science Institute

Locations

Scripps Translational Science Institute

La Jolla, California, United States

Countries

United States

Other Identifiers

1UL1TR001114-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-6293

Identifier Type: -

Identifier Source: org_study_id