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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 January 2013 |
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Main ID: |
NCT01452100 |
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Date of registration:
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15/09/2011 |
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Primary sponsor: |
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Public title:
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Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism)
MECCORT |
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Scientific title:
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Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism) |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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140 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01452100 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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France
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Contacts
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Name:
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Dominique Chauveau, PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Dominique Chauveau, PhD |
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Address:
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Telephone:
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0561323283 |
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Email:
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chauveau.d@chu-toulouse.fr |
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Affiliation:
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Name:
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Antoine Huart, MPD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Toulouse |
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Name:
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Dominique Chauveau, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Toulouse |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Biopsy-proven CCE or clinically diagnosed CCE as assessed on the 3 following criteria
: presence of one or more precipitating factors renal function deterioration in
atherosclerotic patients ischemic changes of the extremities or demonstration of
retinal embolism
- Severe CCE as defined by either acute renal failure (S creatinine > 125 micromol/l
and increase > 25 % of baseline), or severe abdominal changes (hemorrhage,
infarction, perforation or weight loss > 5 % of body weight) or severe central
nervous system neurological complication
Exclusion Criteria:
- CCE unproven, or restricted to one organ, or non-active contraindication to
prednisone.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cholesterol Embolism Systemic
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Intervention(s)
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Drug: prednisone
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Other: placebo
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Primary Outcome(s)
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1-year survival and 1-year renal survival (composite criteria)
[Time Frame: 1 year]
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Secondary Outcome(s)
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course of renal function
[Time Frame: 1 year]
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Number and duration of hospitalization(s)
[Time Frame: 1 year]
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number of cardiovascular events
[Time Frame: 1 year]
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prednisone tolerance
[Time Frame: 1 year]
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Secondary ID(s)
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1003701
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2010-021467-33
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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