Ticagrelol Versus Aspirin in Ischemic Stroke

NCT03884530 | Completed Phase 3 DMC

• 1 other identifier: 2388
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Stroke; Ischemic Stroke

Keywords

ticagrelol; aspirin

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• difference between National institute of health stroke scale scores on admission and after one week in each group

  one week or discharge

• Modified Rankin scale in each group

  after one week and after 3 months

• Mortality in each group

  3 months

Study Arms (2)

Ticagrelor ( Brilique) group

ACTIVE COMPARATOR

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

Aspirin Group

ACTIVE COMPARATOR

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

Interventions

Ticagrelor (Brilique) 90 DRUG

Drug name Brilique 90 ml Drug form tablet

Ticagrelor ( Brilique) group

Aspirin 75mg DRUG

Drug name Aspirin 75 ml Drug form tablet

Aspirin Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kafrelsheikh University: lead
• Ain Shams University: collaborator

Study Sites (1)

Neuropsychiatry department Kafrelsheikh university hospital

Kafr ash Shaykh, 33511, Egypt

Location

Related Publications (3)

• 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 J Med. 2016 Jul 7;375(1):35-43. doi: 10.1056/NEJMoa1603060. Epub 2016 May 10.

  PMID: 27160892 RESULT

• Aref HM, El-Khawas H, Elbassiouny A, Shokri HM, Zeinhom MG, Roushdy TM. A randomized pilot study of the efficacy and safety of loading ticagrelor in acute ischemic stroke. Neurol Sci. 2023 Feb;44(2):765-771. doi: 10.1007/s10072-022-06525-7. Epub 2022 Nov 30.

  PMID: 36446950 DERIVED

• Zeinhom MG, Aref HM, El-Khawas H, Roushdy TM, Shokri HM, Elbassiouny A. A pilot study of the ticagrelor role in ischemic stroke secondary prevention. Eur Neurol. 2022;85(1):50-55. doi: 10.1159/000518786. Epub 2021 Aug 30.

  PMID: 34515113 DERIVED

Related Links

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

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

Ticagrelor; Aspirin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Hani Mohamed M Aref, MD

  neuropsychiatry department Ain shams faculty of medicine

  STUDY CHAIR

• 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

  STUDY DIRECTOR

• Mohamed Zeinhom M Gomaa, M.Sc.

  neuropsychiatry department Kafrelsheikh faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Patients will be divided into 2 groups. The first group formed of 85 patients 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 formed of 84 patients 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).

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 21, 2019
• Study Start: May 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

EG (1)