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.: PACTR202110633346282 Date of Approval: 27/10/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title RIVARAD study
Official scientific title Prevention of Radial Artery Occlusion by Rivaroxaban prescription after Trans-radial access for coronary procedures: a multicentric randomized trial
Brief summary describing the background and objectives of the trial This is an interventional, multicentric trial. the aim is to assess the possibility to prevent radial artery occlusion after a coronary procedure performed by a radial approach by a prophylactic dose of rivaroxaban, prescribed for 7 days after the procedure.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RIVARAD
Disease(s) or condition(s) being studied Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/11/2021
Actual trial start date 01/10/2021
Anticipated date of last follow up 31/03/2022
Actual Last follow-up date 30/04/2022
Anticipated target sample size (number of participants) 512
Actual target sample size (number of participants) 521
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group no intervention we use the strandard treatment no no medication 256 Active-Treatment of Control Group
Experimental Group Rivaroxaban group Rivaroxaban , 10 mg daily , once a day for 7 days medication patients will receive a prophylactic dose of rivaroxaban ( 10mg/day) for 10 days 256
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Willing and able to provide written informed consent 2. Age ≥ 18 years and <80 years 3. Diagnostic coronary angiography or percutaneous coronary intervention via the transradial approach Presence of a palpable hematoma or clinical concern of hemostasis at the transradial access site 2. Access or attempted access at a second site - including contralateral radial artery, brachial, or femoral artery or vein 3. Planned staged procedure, CABG or noncardiac surgery within 30 days 4. Contraindication or high risk of bleeding with anticoagulation a. bleeding requiring medical attention in the previous 6 months b. thrombocytopenia (platelets<50 x 109/L) c. prior intracranial hemorrhage d. use of IIb/IIIa during percutaneous coronary intervention e. administration of thrombolytic therapy in the preceding 24 hours f. use of non-steroidal anti-inflammatory medications g. ischemic stroke or transient ischemic attack diagnosed in the last 3 months 5. Cardiogenic shock 6. Liver dysfunction (Child-Pugh class B or C) 8. Unexplained anemia with a Hemoglobin below 100 g/L 9. History of medication noncompliance or risk factor for noncompliance 10. Active malignancy 11. Allergy to Rivaroxaban 12. Another indication for curative anticoagulation (atrial fibrillation thromboembolic events, intra-cardiac thrombus) 13. CYP3A4 and P-glycoprotein inhibitor use (ex: Ticagrelor) 14. Life expectancy <30 days 15. Women capable of pregnancy not on birth control 16. Chronic kidney disease with creatinine clearance of less than 30mL/min ( calculated with cockroft formula) 17. History of anti-phosphopholipid antibody syndrome 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 30/09/2021 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
Secondary Outcome The secondary endpoints were the following criteria: local complications on the puncture point (aneurysm, hematoma, arterial veinous fistula) BARC bleeding criteria at 30 days. 30 days
Primary Outcome The primary efficacy outcome consists of the rate of radial artery occlusion at 30 days. This event will be assessed by a Doppler ultrasound assessment of the participant's radial artery in the wrist, at 30 days. The primary safety outcome according to consist of the incidence during 30 days of hemorrhagic events defined according to the Bleeding Academic Research Consortium (BARC) criteria and classification. 30 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
hedi chaker hospital road al ain sfax 3029 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
the 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 road elain sfax 3029 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
slim abid farhat hached hospital sousse Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Slim Abid slim.abid@medecinesfax.org 0021624056985 farhat hached hospital
City Postal code Country Position/Affiliation
sousse 3029 Tunisia dr
Role Name Email Phone Street address
Principal Investigator Rania Hammami raniahamammi@yahoo.fr 0021624056985 hedi cheker hospital
City Postal code Country Position/Affiliation
sfax 3029 Tunisia professor
Role Name Email Phone Street address
Scientific 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, Informed Consent Form,Study Protocol not yet available 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 : 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