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Apolipoprotein CIII Reduction Via Colchicine

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ClinicalTrials.gov Identifier: NCT02083510
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : May 30, 2014
Sponsor:
Information provided by (Responsible Party):
Peter G. Schultz, PhD, The Scripps Research Institute

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.

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Gout Pericarditis Drug: Colchicine Early Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Translational Study to Understand the Mechanism of Apolipoprotein CIII Reduction Via Colchicine
Study Start Date : February 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Triglycerides
Drug Information available for: Colchicine

Arm Intervention/treatment
Experimental: 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.
Drug: Colchicine
Other Name: Colcrys




Primary Outcome Measures :
  1. Reduction in ApoCIII levels [ Time Frame: 6 weeks ]
  2. Reduction of triglycerides and very low density lipoprotein (VLDL) levels [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Measurement of Apolipoprotein A and Apolipoprotein B via Vertical Auto Profile (VAP) [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083510


Locations
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United States, California
Scripps Translational Science Institute
La Jolla, California, United States, 92037
Sponsors and Collaborators
Scripps Translational Science Institute
Investigators
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Principal Investigator: Peter Schultz, PhD Scripps Translational Science Institute
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Responsible Party: Peter G. Schultz, PhD, Prinicpal Investigator, The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT02083510    
Other Study ID Numbers: 13-6293
1UL1TR001114-01 ( U.S. NIH Grant/Contract )
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: May 30, 2014
Last Verified: May 2014
Keywords provided by Peter G. Schultz, PhD, The Scripps Research Institute:
Colchicine
Hypertriglyceridemia
Apolipoprotein CIII
Additional relevant MeSH terms:
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Pericarditis
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Heart Diseases
Cardiovascular Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents