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.: PACTR202109714591017 Date of Approval: 28/09/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of heparin reversal by protamine sulfate on the outcome of thrombolysis in acute ischemic stroke after percutaneous coronary intervention
Official scientific title Effect of heparin reversal by protamine sulfate on the outcome of thrombolysis in acute ischemic stroke after percutaneous coronary intervention
Brief summary describing the background and objectives of the trial Intravenous thrombolysis remains unestablished in the area of acute ischemic stroke complicating cardiac catheterization because unfractionated heparin (UFH) is commonly used as a prophylactic treatment. Intravenous protamine sulfate can rapidly (~5 minutes) reverse the anticoagulant effects of heparin. Although it is biologically possible to reverse heparin with protamine prior to tPA administration, the general lack of data precludes formal recommendation in support of this approach. This study aims to determine the efficacy and safety of thrombolysis following heparin reversal with protamine sulfate in acute ischemic stroke in comparison to conservative management.
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 01/10/2021
Actual trial start date 01/10/2021
Anticipated date of last follow up 01/10/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants) 44
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group IV alteplase 0.9 mg / kg ( maximum dose 90 mg ) 1 hour this group will receive heparin reversal by intravenous protamine sulfate at a dose of 50 mg by slow intravenous injection over 10 minutes, with follow up PTT after 10 minutes When PTT drops to < 40 sec (as determined by current guidelines of alteplase infusion) intravenous thrombolysis by alteplase will be administered by intravenous infusion at a dose of 0.9mg/ Kg 22
Control Group loading antiplatelets once single time this group will receive the standard regular medical treatment at our stroke center in the form of loading Anti-platelet: Clopidogrel 600mg single dose or ticagrelor180 mg 22 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adults (~18 years or over) undergoing elective or emergency PCI. 2. Acute ischemic stroke, defined as focal neurological deficit occurring during or immediately after PCI, and diagnosed by an expert neurologist. 3. Stroke within 4 hours of onset. 4. National institutes of health stroke scale (NIHSS) ranging from 4-15. 5. NIHSS < 4 if causing significant deficit (e.g.: aphasia). 6. CT brain is negative for hemorrhage. 7. Patients fulfilled the inclusion criteria for TPA. 8. All participants or their relatives give written consent for participation in this study. 1- Adolescents or children (<18 years). 2- Patients who develop intracranial hemorrhagic stroke. 3- Large ischemic stroke (NIH >15). 4- Mild neurological deficit (NIH <3) and no strategic deficit. 5- Stroke onset beyond 4.5 hours 6- Exclusion criteria for TPA Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 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 12/09/2021 research ethics committee
Ethics Committee Address
Street address City Postal code Country
alabasyia cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in NIHSS score from baseline to 24hrs and on discharge . baseline , 24 hours and on discharge
Primary Outcome Rate of significant bleeding events and the rate of mortality during the hospital stay during hospital stay
Secondary Outcome secondary outcome measures were mRS on discharge and after 3months on discharge and after 3 months
Secondary Outcome duration of hospital stay variable
Primary Outcome Change in NIHSS score from baseline to 24hrs and on discharge . baseline , 24 hours and on discharge
Primary Outcome Rate of significant bleeding events and the rate of mortality during the hospital stay during hospital stay
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University hospitals al-khalifa al-maamoun Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
khaled fayez elmancy alkhalifa al maamoun - alabasyia cairo 11591 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor neurology department ain shams university alabasyia cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator fatma kenawy kh.elmancy2020@gmail.com +201128593444 misr elgdeda
City Postal code Country Position/Affiliation
cairo Egypt lecturer
Role Name Email Phone Street address
Public Enquiries ahmed elbasiouny e_sara2016@yahoo.com +201222132125 elteseen
City Postal code Country Position/Affiliation
cairo Egypt professor
Role Name Email Phone Street address
Scientific Enquiries hany aref sasokh72@gmail.com +201001520053 abbas elakkad
City Postal code Country Position/Affiliation
cairo Egypt professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will be available upon request after completion of the study Study Protocol 2 years controlled, requested , study protocol and annomyous patient data after publication
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 17/02/2025 PACTR Admin 01 Oct 2021
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 28/06/2024 low incidence of stroke after PCI 60 44
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 28/06/2024 THE final number of recruitment 44
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 10/05/2024 started recruiting since june 2023 Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 28/06/2024 COMPLETE RECRUITMENT Recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 28/06/2024 add word significant 1. Adults (~18 years or over) undergoing elective or emergency PCI. 2. Acute ischemic stroke, defined as focal neurological deficit occurring during or immediately after PCI, and diagnosed by an expert neurologist. 3. Stroke within 4 hours of onset. 4. National institutes of health stroke scale (NIHSS) ranging from 4-15. 5. NIHSS < 4 if causing strategic deficit (e.g.: aphasia). 6. CT brain is negative for hemorrhage. 7. Patients fulfilled the inclusion criteria for TPA. 8. All participants or their relatives give written consent for participation in this study. 1. Adults (~18 years or over) undergoing elective or emergency PCI. 2. Acute ischemic stroke, defined as focal neurological deficit occurring during or immediately after PCI, and diagnosed by an expert neurologist. 3. Stroke within 4 hours of onset. 4. National institutes of health stroke scale (NIHSS) ranging from 4-15. 5. NIHSS < 4 if causing significant deficit (e.g.: aphasia). 6. CT brain is negative for hemorrhage. 7. Patients fulfilled the inclusion criteria for TPA. 8. All participants or their relatives give written consent for participation in this study.
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 28/06/2024 low incidence of stroke after PCI Control Group, loading antiplatelets , once, single time, this group will receive the standard regular medical treatment at our stroke center in the form of loading Anti-platelet: Clopidogrel 600mg single dose or ticagrelor180 mg, 22, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 28/06/2024 Low incidence of stroke after PCI Experimental Group, IV alteplase, 0.9 mg / kg ( maximum dose 90 mg ), 1 hour, this group will receive heparin reversal by intravenous protamine sulfate at a dose of 50 mg by slow intravenous injection over 10 minutes, with follow up PTT after 10 minutes When PTT drops to < 40 sec (as determined by current guidelines of alteplase infusion) intravenous thrombolysis by alteplase will be administered by intravenous infusion at a dose of 0.9mg/ Kg , 30, Experimental Group, IV alteplase, 0.9 mg / kg ( maximum dose 90 mg ), 1 hour, this group will receive heparin reversal by intravenous protamine sulfate at a dose of 50 mg by slow intravenous injection over 10 minutes, with follow up PTT after 10 minutes When PTT drops to < 40 sec (as determined by current guidelines of alteplase infusion) intravenous thrombolysis by alteplase will be administered by intravenous infusion at a dose of 0.9mg/ Kg , 22,
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 07/01/2025 Change in NIH in 24hrs is more accurate and used in SITS scoring Primary Outcome, The pre-defined primary efficacy outcome measure is the change in NIHSS score from baseline to 48hrs and on discharge . , baseline , 48 hours and on discharge Primary Outcome, Change in NIHSS score from baseline to 24hrs and on discharge . , baseline , 24 hours and on discharge
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 07/01/2025 increase safety of patients Primary Outcome, The pre-defined primary safety measures are the rate of significant bleeding events and the rate of mortality during the hospital stay , 48 hours and on discharge Primary Outcome, Rate of significant bleeding events and the rate of mortality during the hospital stay , during hospital stay