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.: PACTR202202707050206 Date of Approval: 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 Tenecteplase versus Alteplase in Thrombolysis of Ischemic Stroke in developping country. (ESTATIS)
Official scientific title Efficacy and Safety of Tenecteplase versus Alteplase in Thrombolysis of Ischemic Stroke in developping country. (ESTATIS)
Brief summary describing the background and objectives of the trial To compare the efficacy and safety of tenecteplase versus alteplase in the thrombolysis of ischemic stroke in the acute phase in a Moroccan population.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ESTATIS
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 01/10/2019
Actual trial start date
Anticipated date of last follow up 28/02/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL http://www.chu-fes.ma/recherche/ESTATISresults
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 Alteplase stroke thrombolysis with standard care Alteplase 0.9 mg / kg with 10% of the total intravenous bolus dose administered and 90% of the total intravenous infusion dose over 1 hour (maximum 90 mg dose). 1 hour for active comparator: alteplase - Intravenous recombinant tissue plasminogen activator (rtPA) Alteplase as active comparator: 10% of the total intravenous bolus dose administered and 90% of the total intravenous infusion dose over 1 hour 40 Active-Treatment of Control Group
Experimental Group Tenecteplase stroke thrombolysis Tenecteplase 0.25 mg / kg administered as a single rapid intravenous bolus (maximum 25 mg dose). 1 minute single rapid intravenous bolus Intravenous tenecteplase 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Man or woman not pregnant ≥ 18 years old. - Clinical picture suggestive of a stroke - <4.5h after the onset of symptoms. - cerebral CT or cerebral MRI showing no hemorrhage - Informed consent of the patient or his legal representative. - Independent before stroke (Modified Rankin scale estimated 0-1). - Evidence of intracranial hemorrhage - Other significant intracranial pathology without cerebrovascular accident likely to account for clinical presentation or risk of intracerebral hemorrhage (eg central nervous system neoplasm) in computed tomography (CT) pretreatment - stroke within the previous 14 days, thrombolytic therapy within the last 14 days, or CT scan hypodensity pretreatment consistent with recent cerebral ischemia other than the presentation event - systolic blood pressure greater than 185 or diastolic blood pressure greater than 110 mmHg, or which remains greater than 185 or diastolic blood pressure greater than 110 mmHg despite adequate intravenous drug management) necessary to lower the blood pressure to these limits - Clinical history suggestive of subarachnoid hemorrhage, even if no blood is visible during a computed tomography (CT) scan - High risk of bleeding, including major surgery, trauma or gastrointestinal or urinary hemorrhage during the previous 21 days; Arterial puncture at a non-compressible site within the previous 7 days; Extended cardiopulmonary resuscitation (> 2 minutes) in the previous 14 days; Acute pericarditis and / or subacute bacterial endocarditis; acute pancreatitis; Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (esophageal varices) and active hepatitis; Active peptic ulceration; History of Hemorrhagic Stroke Known Fate of Coagulation or Platelet Function (Other than Antiplatelet Therapy) - Hypo- or hyperglycemia (blood glucose <2 mmol / l or> 18 mmol / l) sufficient to explain neurological symptoms; Seizure at onset of symptoms unless brain imaging identifies positive signs of significant cerebral ischemia (eg, early ischemic change with ASPECTS score <7/10) - Pregnancy (for women of childbearing age, a negative pregnancy test will be required before randomization); - Insufficient haemostasis: o Patient on anti-vitamin K therapy and International Standard Report (INR)> 1.3 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) 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 27/06/2019 Hospital and university ethical comittee 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 Modified Rankin scale [Timeline: Day 90 (+/- 7)] See Annex 1 Modified Rankin Scale (mRS) at day 90, during the 90-day consultation or determined by Telephone. Day 90 Modified Rankin Scale
Secondary Outcome - Complete neurological recovery (modified Rankin scale 0-1 vs. 2-6). Day 90
Secondary Outcome Independent recovery (Modified Rankin Score changed 0-2 vs. 3-6). day 90
Secondary Outcome Early major neurological improvement of 8 points or more, or return to the National Institutes of Health Stroke Scale (NIHSS) score of 0 or 1 to 24 hour (s). 24 hours
Secondary Outcome Score of Barthel's index Day 90
Secondary Outcome Mortality Day 90
Secondary Outcome Neurological deterioration NIHSS score increase ≥ 4 points from baseline 24 hours
Secondary Outcome Intracerebral symptomatic haemorrhage (SICH) Parenchymatous hematoma type 2 (PH2) haemorrhage on cerebral CT until 36 hours after treatment. 36 hours
Secondary Outcome Any intracranial hemorrhage on a CT scan 36 hours
Secondary Outcome Significant extracranial haemorrhage (need for blood transfusion or hemoglobin drop ≥20 mg / l within 36 hours after treatment). 36 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
neurology department of 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
university hospital of FEZ Sidi Harazem street Fez 30000 Morocco
HASSAN II UNIVERSITY HOSPITAL OF FEZ SIDI HARAZEM STREET FEZ 30000 Morocco
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hassan II unversity hospital Hassan II unversity hospital SIDI HARAZEM STREET Fez 30050 Morocco Hospital
COLLABORATORS
Name Street address City Postal code Country
BOUCHAL SIHAM SIDI HARAZEM STREET Fez 30000 Morocco
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator FAOUZI BELAHSEN belahsenfaouzi@gmail.com +212670057237 Neurology department F1 university hospital of Fez
City Postal code Country Position/Affiliation
Fez 30050 Morocco head of department of neurology
Role Name Email Phone Street address
Public Enquiries Naima CHTAOU naimachtaou@gmail.com +212664838010 Neurology Department, University hospital of Fez
City Postal code Country Position/Affiliation
Fez 30050 Morocco Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Nabil Tachfouti tachfoutinabil@yahoo.fr +212615293711 Faculty of medecine and pharmacy of Fez, SIDI HARAZEM street
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