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.: PACTR201905578860441 Date of Approval: 13/05/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of efficacy and safety of intravenous Alteplase (rt-PA) versus Aspirin therapy to improve outcome in patients with acute ischemic stroke
Official scientific title Comparison of efficacy and safety of intravenous Alteplase (rt-PA) versus Aspirin therapy to improve outcome in patients with acute ischemic stroke
Brief summary describing the background and objectives of the trial The aim of this study is to compare the efficacy and safety of thrombolysis with IV Alteplase (rt-PA) versus conservative treatment with aspirin in improving functional outcomes of patients with acute ischemic stroke.
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 28/01/2018
Actual trial start date 28/01/2018
Anticipated date of last follow up 01/04/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
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 Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Alteplase group 0.9 mk/kg body weight not exceeding 90 mg 10% of the dose are revived as bolus dose over 2 minutes and the rest over 1 hour Intra venous infusion using a syringe pump 40
Control Group Aspirin 300 mg loading dose and 150 mg once daily. for the duration of the study up to three monthes for each patient Oral intake the loading 300 mg are taken as chewable dose and the other maintenance dose is given orally by swallowing after lunch 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Age 18 year or older 2- Clinical diagnosis of ischemic stroke with measurable neurological deficit. 1. Evidence of intra-cranial hemorrhage on non-contrast CT (computerized tomography). 2. Clinical suspicion of sub-arachnoid hemorrhage even with normal CT. 3. CT shows multi-lobar infarction (hypo-density greater than 1/3 cerebral hemisphere). 4. History of intra-cranial hemorrhage. 5. Uncontrolled hypertension: at time treatment systolic blood pressure remains>185 mm hg or diastolic blood pressure remains>110 despite repeated measurements. 6. Known arteriovenous malformation, neoplasm, or aneurysm. 7. Witnessed seizure at stroke onset. 8. Acute bleeding tendencies as low platelet count < 10000/mm3, heparin received prior 48 hours with elevated PTT, or current use of anticoagulant (Coumadin /warfarin) with elevated INR. 9. Intra-cranial or spinal surgery, or head trauma within prior 3 months. 10. Arterial puncture at non compressible site within last 7 days. 11. Woman of child bearing age who has a positive pregnancy test. 12. NIH stroke scale>22 (sever deficit) or <4 and no dysphasia (mild deficit) or rapidly improving symptoms. 13. 14 days post-operative or post trauma. 14. Recent GI or urinary tract hemorrhage (prior 21 days). 15. Recent acute myocardial infarction (prior 3 months). 16. Post myocardial infarction pericarditis. 17. Glucose level < 50 which is resistant for correction by glucose infusion. 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) 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 28/01/2018 Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar Shibin Elkom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome is assessed changes in neurological deficits 24 hours after the onset of stroke as a measure of the activity of t-PA by National Institution of Health Stroke Scale NIHSS interpretation. Early neurological improvement was defined as an NIHSS score of 0 or 1 at 24 h after treatment or a decrease of 4 points or more in NIHSS score at 24 h after treatment. 24 hours
Secondary Outcome Modified Rankin Scale MRS with MRS 0 to 1 as favorable outcome and MRS more than 2 as non favorable outcome. 3 monthes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menofia University Hospital 25 Yasin Adb-Elghafar Shibin El Koom 002048 Egypt
New Nozha Hospital 58 Moharam Beek Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of medicine 25 Yasin Abd-Elghafar Shebin Elkom 002048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine 25 Yasin Abd-Elghafar Shebin Elkom 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Emad Mobarak Abd El Atey Torkey El Tahreer Delengat El Behira Governement Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emad torkey emadtorkey3@gmail.com 00201002990626 El tahreer street
City Postal code Country Position/Affiliation
Delengat EL Behira governement Egypt researcher doctor
Role Name Email Phone Street address
Public Enquiries Nadia Mohee El Din Bahgat Abbas dr_nmbahgat@yahoo.com 00201009558238 25 Yasin Abd-Elghafar
City Postal code Country Position/Affiliation
Shebin Elkom 002048 Egypt Lecturer of Anesthesiology and Intensive Care
Role Name Email Phone Street address
Public Enquiries Amr El fatatrey amrelfatatry@gmail.com 01223925467 58 El Rasafa Moharam Beek
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant Professor of Neuropsychiatry Faculty of Medicine Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Yaser Fathey dr_nmbahgat@yahoo.com 01099004664 25 Yasin Abd-Elghafar
City Postal code Country Position/Affiliation
Shebin Elkom Egypt Assistant Professor of Anesthesiology and Intensive Care Faculty of Medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes age, weight, blood pressure, pulse, premedication NIHSS, third month NIHSS, third month MRS, Hospital stay mortality and complications. Informed Consent Form,Statistical Analysis Plan,Study Protocol May 2019 October 2019 efficacy, safety, intravenous Alteplase (rt-PA), Aspirin, outcome ,acute, ischemic, stroke
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
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided Informed Consent Form,Statistical Analysis Plan,Study Protocol
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
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided Informed Consent Form,Statistical Analysis Plan,Study Protocol
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
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided Informed Consent Form,Statistical Analysis Plan,Study Protocol
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