Ticagrelol Versus Aspirin in Ischemic Stroke

Ischemic Stroke Clinical Trial

Official title:

Ticagrelol Versus Aspirin in Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03884530
• Other study ID #: 2388
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: August 2021
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Ticagrelor (Brilique) 90
Drug name Brilique 90 ml Drug form tablet
• Aspirin 75mg
Drug name Aspirin 75 ml Drug form tablet

Locations

Country	Name	City	State
Egypt	Neuropsychiatry department Kafrelsheikh university hospital	Kafr Ash Shaykh

Sponsors (2)

Lead Sponsor	Collaborator
Kafrelsheikh University	Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Johnston SC, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Jonasson J, Minematsu K, Molina CA, Wang Y, Wong KS; SOCRATES Steering Committee and Investigators. Ticagrelor versus Aspirin in Acute Stroke or Transient Ischemic Attack. N Engl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemorrhagic transformation of infarction within 48 hours of loading anti platelet in each group	hemorrhagic transformation detected by brain imaging CT and/or MRI brain will be done after 2 days of onset	48 hours
Primary	amount of peripheral bleeding within 48 hours of loading anti platelet in each group	amount of peripheral bleeding measured in milliliter in each group	48 hours
Primary	frequency of peripheral bleeding within 48 hours of loading anti platelet in each group	amount of peripheral bleeding measured as ( time per day )	48 hours
Secondary	difference between National institute of health stroke scale scores on admission and after one week in each group	National institute of health stroke scale ( NIHSS) difference between score on admission and after one week: we consider favorable outcome if there is decrease in NIHSS by 4 points or more 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	one week or discharge
Secondary	Modified Rankin scale in each group	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 we consider favorable mRS if it was 2 or less	after one week and after 3 months
Secondary	Mortality in each group	Timing and cause of death will be assessed	3 months

External Links

•   https://www.ncbi.nlm.nih.gov/pubmed/27160892