Ticagrelol Versus Aspirin in Ischemic Stroke
Palabras clave
Abstracto
Descripción
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.
fechas
| Verificado por última vez: | 05/31/2019 |
| Primero enviado: | 03/07/2019 |
| Inscripción estimada enviada: | 03/19/2019 |
| Publicado por primera vez: | 03/20/2019 |
| Última actualización enviada: | 06/06/2019 |
| Última actualización publicada: | 06/09/2019 |
| Fecha de inicio real del estudio: | 05/01/2019 |
| Fecha estimada de finalización primaria: | 09/30/2020 |
| Fecha estimada de finalización del estudio: | 03/31/2021 |
Condición o enfermedad
Intervención / tratamiento
Drug: Ticagrelor ( Brilique) group
Drug: Aspirin Group
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| 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) group 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 Group Drug name Aspirin 75 ml Drug form tablet |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | 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 |
Salir
Medidas de resultado primarias
1. hemorrhagic transformation of infarction within 48 hours of loading anti platelet in each group [48 hours]
2. amount of peripheral bleeding within 48 hours of loading anti platelet in each group [48 hours]
3. frequency of peripheral bleeding within 48 hours of loading anti platelet in each group [48 hours]
Medidas de resultado secundarias
1. difference between National institute of health stroke scale scores on admission and after one week in each group [one week]
2. Modified Rankin scale in each group [3 months]
3. Mortality in each group [3 months]
