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.: PACTR202202477162480 Date of Registration: 10/02/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy and safety of RivaroXaban and DAbigatran versus AcenocouMarol in Cerebral Venous Thrombosis
Official scientific title Efficacy and safety of RivaroXaban and DAbigatran versus AcenocouMarol in Cerebral Venous Thrombosis (EXAMinCVT)
Brief summary describing the background and objectives of the trial The use of New Oral Anticoagulants (NOACs) has been proposed and reported in retrospective studies for other situations where the neurologist is required to prescribe an AVK. Small series have been reported in Cerebral venous Thrombosis with promising results. Clinical trials are ongoing and compare one of the NOACs with Warfarin. It is proposed to carry out a similar study comparing NOACs (rivaroxaban, dabigatran) with acenocoumarol (the only VKA marketed in Morocco) in a Moroccan population with cerebral venous thrombosis.This study is designed to evaluate the efficacy and safety of dabigatran and rivaroxaban compared to INR 2 - 3 adjusted acenocoumarol.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EXAMinCVT
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/04/2019
Actual trial start date
Anticipated date of last follow up 31/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Recruiting
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
Control Group Acenocoumarol start at 1/2 cp (2 mg) and adjusted according to the INR (goal between 2 -3) 6 months Acenocoumarol start at 1/2 cp (2 mg) and adjusted according to the INR (goal between 2 -3) 20 Active-Treatment of Control Group
Experimental Group Dabigatran Dabigatran: 150 mg twice daily f 6 months after randomization. Experimental Medication (Arm 1): Dabigatran: 150 mg twice daily for 6 months after randomization. 20
Experimental Group rivaroxaban Rivaroxaban: 20 mg once a day 6 month after randomisation Experimental group (Arm 2): Rivaroxaban: (20 mg) once a day during 6 months 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Informed consent written in accordance with the rules of good clinical practice and laws in force in the country. 2. Confirmed diagnosis of venous or cerebral thrombosis (DVT), with or without intracranial hemorrhage (CT scan injected or brain MRI) 3. Curative dose anticoagulant (LMWH) therapy that has been administered from confirmation of diagnosis to randomization; 4. Eligibility for oral anticoagulant therapy. 1. Cerebral venous thrombosis (CVT) associated with central nervous system infection or head trauma. 2. Medical or surgical conditions associated with an increased risk of bleeding 3. History of symptomatic nontraumatic intracranial hemorrhage at high risk of recurrence 4. Treatment with an antithrombotic regimen for an indication other than CVT and requiring continuation of this treatment for the initial diagnosis without modification of the treatment regimen 5. Severe renal insufficiency 6. Active hepatopathy 7. Pregnancy ongoing or planned during the clinical trial 8. Any contraindications to VKA or NOAC. 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
No 07/02/2019 Hospital and university ethics committee of Fez
Ethics Committee Address
Street address City Postal code Country
faculty of medecine and pharmacy of Fez Fez 30050 Morocco
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mortality (any cause) in the year following randomization, major bleeding or new venous thrombotic event (VTE) After one year
Secondary Outcome Cerebral venous recanalization measured by change in the number of occluded cerebral veins and dural sinuses after 24 week. 24 weeks
Secondary Outcome Number of patients with clinically significant non-major bleeding events after 24 weeks 24 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Neurology department at university hospital of Fez hassan II university hospital of Fez, Sidi Harazem Street Fez 30050 Morocco
FUNDING SOURCES
Name of source Street address City Postal code Country
Research budget of university hospital Sidi HARAZEM street Fez 30000 Morocco
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hasan II University Hospital of Fez Hasan II University Hospital of Fez, sidi HARAZEM Street Fez 30050 Morocco Hospital
COLLABORATORS
Name Street address City Postal code Country
CHTAOU Naima Sidi Harazem Street Fez 30000 Morocco
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Faouzi Belahsen belahsenfaouzi@gmail.com +212670057237 Neurology department of Hassan II university Hospital, Sidi Harazem Street
City Postal code Country Position/Affiliation
Fez 30050 Morocco Head of Department
Role Name Email Phone Street address
Public Enquiries Naima Chtaou naimachtaou@gmail.com +212664838010 Neurology department of HASSAN II university hospital of Fez
City Postal code Country Position/Affiliation
Fez 30050 Morocco Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries Nabil Tachfouiti tachfoutinabil@yahoo.fr +212615293711 Epidemiology Department, Faculty of medecine and pharmacy of Fez
City Postal code Country Position/Affiliation
Fez 30050 Morocco Associate Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data will be available 6 months after study completion date, after deidentification Study Protocol 1 year (6 months after study completion date) open access type of data: individual partipant data that underlie the results reported in article (text, tables, figures and appendices)
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