Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202110707328144 Date of Approval: 25/10/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of ATOrvastatin REload on the Prevention of Contrast-INduced Nephropathy in patients on Chronic Statin Therapy: A prospective randomized trial (ATORE-CIN)
Official scientific title Impact of Atorvastatin Reload on the Prevention of Contrast-Induced Nephropathy
Brief summary describing the background and objectives of the trial A high dose of atorvastatin before coronary procedures reduce the risk of Contrast-Induced Nephropathy in statin naive patients. This trial aimed to assess the efficacy of Atorvastatin reload on the prevention of Contrast-Induced Nephropathy in patients pre-treated with this statin and undergoing coronary catheterization.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ATORECIN
Disease(s) or condition(s) being studied renal diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/06/2020
Actual trial start date 30/09/2020
Anticipated date of last follow up 15/10/2020
Actual Last follow-up date 15/10/2020
Anticipated target sample size (number of participants) 102
Actual target sample size (number of participants) 110
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Reload patients on chronic statin therapy with high dose of atorvastatin 80 mg of atorvastatin one day before contrast injection and three days after Reload patients on chronic statin therapy with high dose of atorvastatin 55
Control Group no relaod statin nothing nothing contrast injection without statin reloading 55 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
This is a prospective, randomized, single-blind, controlled trial, implemented in all consecutive patients (older than 18 years), undergoing coronary angiography or percutaneous coronary intervention in our department between June 2020 and September 2020 and who had already been receiving atorvastatin for at least one week, before admission. *patients admitted because of an acute coronary syndrome in whom a loading dose is recommended according to guidelines, *statin-naïve patients, *patients who received a statin other than atorvastatin before the procedure, *patients already receiving 80 mg atorvastatin, patients requiring dialysis and those with eGFR less than 15 ml/min/ 1.73 m2, *patients who were exposed to a contrast medium within 7 days, patients with an allergy to contrast media, *patients with cardiogenic shock or severe cardiac insufficiency (left ventricular ejection fraction LVEF <20%), *patients with severe liver damage, malignant tumor, infectious disease, or fever, *and those who refused to consent. * patients who didn't return to get control laboratory tests 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/04/2020 CPP sud
Ethics Committee Address
Street address City Postal code Country
hedi chaker hospital sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the incidence of Cys-based CIN defined as an increase in serum CyC concentration by 10% above the baseline value 24 hours after contrast media administration (17) and the incidence of SCr-based CIN defined as the increase in SCr the concentration of 44.2 mmol/L or 25% above baseline within 72 hours after exposure to contrast media. 24 hours and 72 hours
Secondary Outcome The secondary end-point was to detect any acute kidney injury by a significant rise in cystatin C level between baseline and 24 hours in the two groups ( AR and NR groups). We assessed the risk of CIN before the procedure using the Mehran score (20). The risk of CIN was considered low if Mehran’s score =0-5, moderate if Mehran’s score=6-10, High if Mehran’s score>10. 24 h and 72 h
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
cardiology departement of sfax service de cardiologie sfax 3029 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
hedi chaker hospital hedi chaker hospital sfax 3029 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor hedi chaker hospital hedi chaker hospital sfax 3029 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Omar masmoudi hedi chaker hospital sfax 3029 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Rania Hammami raniahammami@yahoo.fr 0021624056985 heddi chaker hospital
City Postal code Country Position/Affiliation
sfax 3029 Tunisia professor
Role Name Email Phone Street address
Principal Investigator omar masmoudi masmoudiomar@hotmail.com 0021626823843 heddi chaker hospital
City Postal code Country Position/Affiliation
sfax 3029 Tunisia fellow
Role Name Email Phone Street address
Public Enquiries rania hammami raniahammami@yahoo.fr 0021624056985 hedi chaker hospital
City Postal code Country Position/Affiliation
sfax 3029 Tunisia professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Will individual participant data be available (including data dictionaries)? Yes What data, in particular, will be shared? all of the individual participant data collected during the trial, after identification What other documents will be available? Study Protocol, Informed Consent form Study Protocol When will data be available (start and end date)? Beginning 9 months and ending 36 months following article publication open all types of data analysis With who? Researchers, who provide a methodologically sound proposal For what types of analyses? To achieve aims in the approved proposal By what mechanism will date be made available: The proposal should be directed to raniahammami@yahoo.fr To gain access, data requestors will need to sign a data access agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information