Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-03-04 @ 4:58 AM
Study NCT ID:
NCT01452100
Status:
TERMINATED
Last Update Posted:
2016-05-09
First Post:
2011-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004617', 'term': 'Embolism'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'whyStopped': 'Inclusion default', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-06', 'studyFirstSubmitDate': '2011-09-15', 'studyFirstSubmitQcDate': '2011-10-13', 'lastUpdatePostDateStruct': {'date': '2016-05-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1-year survival and 1-year renal survival (composite criteria)', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Number and duration of hospitalization(s)', 'timeFrame': '1 year', 'description': 'Number and duration of hospitalization(s)'}, {'measure': 'course of renal function', 'timeFrame': '1 year', 'description': 'stable, deterioration or improvement of serum creatinine - defined by changes \\> 20 % compared to base line'}, {'measure': 'number of cardiovascular events', 'timeFrame': '1 year', 'description': 'acute coronary syndrome, stroke, heart failure, critical lower member ischemia, digestive ischemia'}, {'measure': 'prednisone tolerance', 'timeFrame': '1 year', 'description': 'as regard to de novo diabetes mellitus, and severe psychiatric or infectious episode (requiring hospitalization).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['embolism', 'cholesterol cristal', 'creatinine', 'renal insufficiency', 'prednisone', 'systemic atheroembolism'], 'conditions': ['Cholesterol Embolism Systemic']}, 'descriptionModule': {'briefSummary': 'Cholesterol cristal embolization (CCE) is an orphan multisystem vascular condition occurring in elderly with severe atherosclerosis.\n\nIn most patients, avoiding the precipitating factors and combination of statin and RAS inhibitor are recommended.\n\nThe 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.', 'detailedDescription': '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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* 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\n\nExclusion Criteria:\n\n* CCE unproven, or restricted to one organ, or non-active contraindication to prednisone.'}, 'identificationModule': {'nctId': 'NCT01452100', 'acronym': 'MECCORT', 'briefTitle': 'Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism)', 'orgStudyIdInfo': {'id': '1003701'}, 'secondaryIdInfos': [{'id': '2010-021467-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'prednisone', 'description': '• 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).', 'interventionNames': ['Drug: prednisone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': '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).', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'prednisone', 'type': 'DRUG', 'otherNames': ['Cortancyl'], 'description': '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).', 'armGroupLabels': ['prednisone']}, {'name': 'placebo', 'type': 'OTHER', 'description': '• 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).', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31052', 'city': 'Toulouse', 'state': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse service néphrologie', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Dominique Chauveau, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Toulouse'}, {'name': 'Antoine Huart, MPD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}