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.: PACTR202301861240705 Date of Approval: 31/01/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A prospective clinical and radiological study of incidental cerebral small vessel disease: Aspirin versus Cilostazol (PACCS)
Official scientific title A prospective clinical and radiological study of incidental cerebral small vessel disease: Aspirin versus Cilostazol (PACCS)
Brief summary describing the background and objectives of the trial Background: Cerebral small vessel disease is a disorder of the brain’s small perforating arterioles, capillaries, and probably venules, that causes various lesions that are seen on pathological examination or brain imaging with MRI or CT (wardlaw 2019). These lesions might be clinically silent individually, and many affected people do not have symptoms, but increasing numbers of individual lesion types and combinations of lesion types are associated with cognitive impairment, dementia, depression, mobility problems, increased risk of stroke, and worse outcome after stroke. Since White Matter Hyperintensities (WMH) progression is associated with clinical consequences, WMH progression may be used as a surrogate marker in preventive trials. Several longitudinal studies with serial MRI investigated the risk factors for WML progression (Mok and Kim, 2015). The proposed study is a longitudinal, single-blind, randomized clinical trial in which 220 patients with incidental cerebral small vessel disease will be recruited over the course of one year. Patients will be divided into two groups, the first receiving aspirin 150 mg/day and the second receiving cilostazol 200 mg/day. At baseline there will be clinical assessment using cognitive scales (MoCA, BMET, BDI), motor scales (10 MW test, Time up and Go, Berg Balance Scale), urinary assessment using ICIQ, and radiological assessment MRI brain done for all patients Follow-up with patients will be done after one year to compare clinical and radiological progression between the two groups. Objectives of the trial: The primary aim of this study is to compare the outcome of cognitive performance, gait function, and sphincteric affection in SVD patients between the patient group receiving aspirin and the group receiving cilostazol. The secondary aim of this study is to compare the progression of the white matter intensities, lacunes, microbleeds, and brain atrophy in the studied groups.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 01/02/2023
Actual trial start date
Anticipated date of last follow up 01/02/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 220
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 Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Aspirin Arm 1 Year Follow Up Patients with SVD randomly and equally allocated into 2 groups First group receiving Aspirin 110 Active-Treatment of Control Group
Experimental Group Cilostazol Arm one year follow up Patients with SVD randomly and equally allocated into 2 groups Second group receiving Cilostazol 110
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patient aged 45 or Above suffering from incidental cerebral SVD Patients presenting with slowly progressive cognitive, urinary, gait abnormalities and/or depression, rather than acute stroke presentation. MRI brain suggestive of small vessel disease in the form of deep white matter hyperintensities (WMH), lacunes, cerebral microbleeds, enlarged Virchow spaces, silent small subcortical infarct ● Patients with acute onset stroke of any source (Ex: CADASIL) ● Patients with past history of acute large vessel stroke ● Patients with large vessel occlusion or stenosis >50% ● Contraindication to MRI (as pacemakers or metal plates and screws) ● Alcohol addiction or substance abuse (to exclude substance induced vasculitis) ● Any neurological disease affecting white matter (eg; Multiple sclerosis, sarcoidosis, etc), ● Any neurological disease presenting with symptoms similar to cerebral small vessel disease 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 85 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 01/01/2023 Ain Shams University Faculty of Medicine Research ethics committee REC
Ethics Committee Address
Street address City Postal code Country
Abbasseya Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Describe Progression of lesions in MRI after one year of receiving single antiplatlet 1 year follow up
Secondary Outcome Assess side effects of aspirin versus ciolstazol in patients with incidental cerebral small vessel disease 1 year follow up
Primary Outcome Explore the progression of the white matter intensities, lacunes, microbleeds and brain atrophy in the studied groups. 1 year
Primary Outcome Assess the difference in cognitive performance, gait and sphincteric affection in SVD patients between the intervention groups (aspirin versus cilostazol). 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospital El Demerdash Abbaseya Cairo Egypt
Ain Shams University Specialized Hospital Al Khalifa Al Maamoun Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hany Aref El Nakheel - Al Shorouk City Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hany Aref Villa 58, El Nakheel, El Shorouk City Cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hany Aref haref30@hotmail.com 01001520053 Villa 58, El Nakheel, El Shorouk City
City Postal code Country Position/Affiliation
Cairo Egypt Professor of Neurology Ain Shams University
Role Name Email Phone Street address
Public Enquiries Yasmine Abdelhamid yas.h.abdelhamid@gmail.com +201004892175 354 - Al Narges Buildings - New Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Assistant lecturer of neurology Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Nevine El Nahas nevine_elnahas@med.asu.edu.eg +201227910517 Villa 58, El Nakheel, El Shorouk City
City Postal code Country Position/Affiliation
Cairo Egypt Professor of Neurology Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Hany Aref haref30@hotmail.com +201001520053 Villa 58, El Nakheel, El Shorouk City
City Postal code Country Position/Affiliation
Cairo Egypt Professor of neurology Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article will be available after deidentification, Beginning 9 months and ending 36 months following article publication, for Researchers who provide a methodologically sound proposal Study Protocol Recruitment of patients over one year, follow up for one year Controlled access for PI, coPI, and public inquiries contact, editors and reviewers assigned by journal of submission Type of data analysis permitted: no data analysis permitted Requesting data: from PI and co PI Reviewing requests: specialized neurologists
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