Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ticagrelol Versus Aspirin in Ischemic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884530
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : June 10, 2019
Sponsor:
Collaborator:
Ain Shams University
Information provided by (Responsible Party):
Mohamed zeinhom Gomaa, Kafrelsheikh University

Brief Summary:

There is a debate whether ticagrelor is superior to aspirin in treating patients with ischemic stroke or not, most of the studies examine the effect of both drugs within 24 hours of acute stroke some find that there is no difference between ticagrelor and aspirin, others find that ticagrelor is superior to aspirin.

At this study the investigators aim at evaluating the role of loading ticagrelor received within 9 hours of acute ischemic stroke in improving neurological outcome of stroke. And evaluating the risk of hemorrhagic and non- hemorrhagic complications associated with the use of ticagrelor180 ml oral loading dose within 9 hours acute ischemic stroke


Condition or disease Intervention/treatment Phase
Acute Stroke Ischemic Stroke Drug: Ticagrelor (Brilique) 90 Drug: Aspirin 75mg Phase 2 Phase 3

Detailed Description:

ticagrelor is acyclo-pentyltriazolo-pyrimidine antiplatelet drug that inhibits the P2Y12which is a subtype of adenosine diphosphate (ADP)receptor.

It is a potent , direct-acting oral agent and it is reversibly binding P2Y12 receptors antagonist unlike the irreversible agents as clopidogrel, prasugrel, ticlopidine.

In 2011, the U.S. Food and Drug Administration (FDA) approved the blood-thinning drug (ticagrelor) to treat acute coronary syndromes, and in 2015, it approved it as long-term treatment in patient with history of heart attack.

In 2018, the American Heart Association ( AHA ) and American stroke Association (ASA) Guidelines for the Early Management of Patients with Acute Ischemic Stroke stated that, ticagrelor was not found to be superior to aspirin. However, because there were no significant safety differences, ticagrelor may be a reasonable alternative in stroke patients who have a contraindication to aspirin.

Aspirin overall reduces the risk of major vascular events by 13% Moreover, the risk of hemorrhagic events limits the use of aspirin in this setting, so the investigators aim at examining the hemorrhagic risks associated with use of loading Ticagrelor 180 ml within 9 hours of 1st ever acute ischemic stroke and compare the neurological outcomes in two groups of patients with 1st ever acute ischemic stroke receiving within 9 hours either Aspirin(300 mg (4 tablets of 75 mg) as a single loading oral dose, and will then be commenced on 300 mg Aspirin daily for 2 weeks then 75 mg daily after that for 3 months and the other received 180 mg ticagrelor (2 tablets of 90 mg) as a single loading oral dose, and continue on 180 mg ticagrelor (1 tablet of 90 mg every 12 hours) for 3 months.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be divided into 2 groups. Each group will include 76 patients. The first group will receive 180 mg ticagrelor (2 tablets of 90 mg) as a single loading oral dose, and continue on 180 mg ticagrelor (1 tablet of 90 mg every 12 hours). The second group will receive 300 mg Aspirin (4 tablets of 75 mg) as a single loading oral dose, and will then be commenced on 300 mg Aspirin daily for 2 weeks then 75 mg daily after that. If the patients showed complications of the loading dose of ticagrelor (central or peripheral bleeding the dose will be minimized to 90 mg (1 tablet of 90 mg).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ticagrelol Versus Aspirin in Ischemic Stroke
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ticagrelor ( Brilique) group
the group will receive 180 mg ticagrelor (2 tablets of 90 mg) as a single loading oral dose, and continue on 180 mg ticagrelor (1 tablet of 90 mg every 12 hours) for 3 months
Drug: Ticagrelor (Brilique) 90
Drug name Brilique 90 ml Drug form tablet

Active Comparator: Aspirin Group
The group will receive 300 mg Aspirin (4 tablets of 75 mg) as a single loading oral dose, and will then be commenced on 300 mg Aspirin daily for 2 weeks then 75 mg daily after that for 3 months
Drug: Aspirin 75mg
Drug name Aspirin 75 ml Drug form tablet




Primary Outcome Measures :
  1. hemorrhagic transformation of infarction within 48 hours of loading anti platelet in each group [ Time Frame: 48 hours ]
    hemorrhagic transformation detected by brain imaging CT and/or MRI brain will be done after 2 days of onset

  2. amount of peripheral bleeding within 48 hours of loading anti platelet in each group [ Time Frame: 48 hours ]
    amount of peripheral bleeding measured in milliliter in each group

  3. frequency of peripheral bleeding within 48 hours of loading anti platelet in each group [ Time Frame: 48 hours ]
    amount of peripheral bleeding measured as ( time per day )


Secondary Outcome Measures :
  1. difference between National institute of health stroke scale scores on admission and after one week in each group [ Time Frame: one week ]

    National institute of health stroke scale ( NIHSS) difference between score on admission and after one week:

    this scale ranges from 0 to 42 . the higher the value the worse outcome with the following values: 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke


  2. Modified Rankin scale in each group [ Time Frame: 3 months ]

    Modified Rankin Scale (MRS): assessed at the end of 3 months , the higher the value the worse the outcome , MRS has following values :

    0 = No symptoms at all

    • 1= No significant disability despite symptoms
    • 2= Slight disability
    • 3= Moderate disability
    • 4= Moderately severe disability
    • 5= Severe disability; bedridden
    • 6= Dead

  3. Mortality in each group [ Time Frame: 3 months ]
    Timing and cause of death will be assessed



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male & female patients will be included
  2. Age between 18 - 75 years
  3. First ever presentation with acute ischemic stroke.Previous transient ischemic attacks (TIA's) are not excluding
  4. Ictus to drug time does not to exceed 9 hours.

Exclusion Criteria

  1. Patient eligible for recombinant tissue plasminogen activator (rTPA)
  2. patients with( national institute of health stroke scale (NIHSS) below 3 or above 25
  3. patients with active malignancy
  4. patients with major surgery in past 3 months
  5. patients with known allergy to study drugs
  6. patients with acute myocardial infarction in past 6 months
  7. patients known to suffer from multiple sclerosis or epilepsy
  8. pregnancy or lactation
  9. patients with history of head trauma with residual neurological deficits
  10. patients on regular ticagrelol in past week
  11. patients with international normalized ratio (INR) more than 1.3 or prothrombin time (PT) more than 18
  12. patients with venous thrombosis
  13. patients with platelet count less than 100000 or white blood cells (WBCs) less than 3000 or hematocrit value less than 0.25
  14. blood glucose less than 50 mg/DL or more than 400

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884530


Contacts
Layout table for location contacts
Contact: mohamed zeinhom M Gomaa, M.Sc. 01009606828 ext 20 mohamedzeinhom7@gmail.com
Contact: Hala M Elkhawas, MD 01005297952 ext 20 halaelkhawas@hotmail.com

Locations
Layout table for location information
Egypt
Neuropsychiatry department Kafrelsheikh university hospital Recruiting
Kafr Ash Shaykh, Egypt, 33511
Contact: mohamed zeinhom M Gomaa, M.Sc.    01009606828 ext 20    mohamedzeinhom7@gmail.com   
Contact: Hala M Elkhawas, MD    01005297952 ext 20    halaelkhawas@hotmail.com   
Sponsors and Collaborators
Kafrelsheikh University
Ain Shams University
Investigators
Layout table for investigator information
Study Chair: Hani Mohamed M Aref, MD neuropsychiatry department Ain shams faculty of medicine
Study Director: Hala M Elkhawas, MD neuropsychiatry department Ain shams faculty of medicine
Study Director: Ahmed I Elbassiouny, MD neuropsychiatry department Ain shams faculty of medicine
Study Director: Tamer M Roushdy, MD neuropsychiatry department Ain shams faculty of medicine
Study Director: Hossam S Mohammed, MD neuropsychiatry department Ain shams faculty of medicine
Principal Investigator: Mohamed Zeinhom M Gomaa, M.Sc. neuropsychiatry department Kafrelsheikh faculty of medicine
Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Mohamed zeinhom Gomaa, principal investigator, Kafrelsheikh University
ClinicalTrials.gov Identifier: NCT03884530    
Other Study ID Numbers: 2388
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: the individual participant data for all primary and secondary outcomes measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: data will be available after 6 months of study completion
Access Criteria: data access requests will be reviewed by an external independent review panel , requestors will be required to sign a data access agreement

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mohamed zeinhom Gomaa, Kafrelsheikh University:
ticagrelol
aspirin
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Aspirin
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists