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Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism) (MECCORT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Hospital, Toulouse
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01452100
First received: September 15, 2011
Last updated: July 30, 2014
Last verified: July 2014

September 15, 2011
July 30, 2014
June 2011
June 2015   (final data collection date for primary outcome measure)
1-year survival and 1-year renal survival (composite criteria) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01452100 on ClinicalTrials.gov Archive Site
  • Number and duration of hospitalization(s) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Number and duration of hospitalization(s)
  • course of renal function [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    stable, deterioration or improvement of serum creatinine - defined by changes > 20 % compared to base line
  • number of cardiovascular events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    acute coronary syndrome, stroke, heart failure, critical lower member ischemia, digestive ischemia
  • prednisone tolerance [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    as regard to de novo diabetes mellitus, and severe psychiatric or infectious episode (requiring hospitalization).
Same as current
Not Provided
Not Provided
 
Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism)
Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism)

Cholesterol cristal embolization (CCE) is an orphan multisystem vascular condition occurring in elderly with severe atherosclerosis.

In most patients, avoiding the precipitating factors and combination of statin and RAS inhibitor are recommended.

The lack of randomized controlled trial in CCE precludes significant advances. The investigators decided to assess whether prednisone started early, at mild dosage and for a short period prevents death and progression to end-stage renal failure in patients with severe CCE, as compared to placebo.

Erosion of atheromatous plaque results in release of cholesterol crystal embolism that ultimately occlude medium-sized arterioles and capillaries of the kidney, skin, gastrointestinal tract and central nervous system. The diagnosis relies on histopathological demonstration of cholesterol cristal embolism in any target organ, or can be assumed if the 3 following criteria are met (1) presence of one or more precipitating factors (2) renal function deterioration in atherosclerotic patients (3) ischemic changes of the extremities or demonstration of retinal CCE. Despite the dismal prognosis in multisystem CCE mortality the optimal treatment remains unknown.

In most patients, avoiding the precipitating factors and combination of statin and RAS inhibitor are recommended. The benefit of prednisone is uncertain, but its dramatic impact has been underlined in several short retrospective series, even with moderate daily dosage (0,2-0,5 mg/kg). However, adverse side effects of steroid therapy in uremic elderly with CCE have not been assessed. In addition, the optimal duration of the treatment has not been assessed. The lack of randomized controlled trial in CCE precludes significant advances. The investigators decided to assess whether prednisone started early, at mild dosage and for a short period prevents death and progression to end-stage renal failure in patients with severe CCE, as compared to placebo.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cholesterol Embolism Systemic
  • Drug: prednisone
    Patients enrolled into the study will be treated with prednisone, 20 mg/day (if body weight <70 kg ; or 25mg/d if body weight >70 kg) for 1 month, then tapered to 12.5 mg/d (month 2) and 7.5 mg/d (month 3) and stop. In both groups, patients will be treated according to expert advice including use of statins (according to French Health Agency recommendation), a RAS inhibitor and supportive treatment (including nutrition, treatment of heart failure, and dialysis).
    Other Name: Cortancyl
  • Other: placebo
    • Patients enrolled into the study will be treated with placebo, 20 mg/day (if body weight <70 kg ; or 25mg/d if body weight >70 kg) for 1 month, then tapered to 12.5 mg/d (month 2) and 7.5 mg/d (month 3) and stop. In both groups, patients will be treated according to expert advice including use of statins (according to French Health Agency recommendation), a RAS inhibitor and supportive treatment (including nutrition, treatment of heart failure, and dialysis).
  • Experimental: prednisone
    • Patients enrolled into the study will be treated with prednisone, 20 mg/day (if body weight <70 kg ; or 25mg/d if body weight >70 kg) for 1 month, then tapered to 12.5 mg/d (month 2) and 7.5 mg/d (month 3) and stop. In both groups, patients will be treated according to expert advice including use of statins (according to French Health Agency recommendation), a RAS inhibitor and supportive treatment (including nutrition, treatment of heart failure, and dialysis).
    Intervention: Drug: prednisone
  • Placebo Comparator: placebo
    Patients enrolled into the study will be treated with placebo, 20 mg/day (if body weight <70 kg ; or 25mg/d if body weight >70 kg) for 1 month, then tapered to 12.5 mg/d (month 2) and 7.5 mg/d (month 3) and stop. In both groups, patients will be treated according to expert advice including use of statins (according to French Health Agency recommendation), a RAS inhibitor and supportive treatment (including nutrition, treatment of heart failure, and dialysis).
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
June 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Dominique Chauveau, PhD 0561323283 ext 33 chauveau.d@chu-toulouse.fr
Contact: Antoine Huart, MD 0561323029 ext 33 huart.a@chu-toulouse.fr
France
 
NCT01452100
1003701, 2010-021467-33
Yes
University Hospital, Toulouse
University Hospital, Toulouse
Ministry of Health, France
Study Director: Dominique Chauveau, PhD University Hospital, Toulouse
Principal Investigator: Antoine Huart, MPD University Hospital, Toulouse
University Hospital, Toulouse
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP