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

NCT01452100 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2016-05-09

No results posted yet for this study

Summary

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.

Conditions

  • Cholesterol Embolism Systemic

Interventions

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

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).

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Dominique Chauveau, PhD · University Hospital, Toulouse

  • Antoine Huart, MPD · University Hospital, Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2015-09-30
Completion
2015-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01452100 on ClinicalTrials.gov