Ticagrelol Versus Aspirin in Ischemic Stroke
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- hemorrhagic transformation of infarction within 48 hours of loading anti platelet in each group
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Exclusion Criteria
- •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
排除标准
- 未提供
研究组 & 干预措施
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
干预措施: Aspirin 75mg (Drug)
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
干预措施: Ticagrelor (Brilique) 90 (Drug)
结局指标
主要结局
hemorrhagic transformation of infarction within 48 hours of loading anti platelet in each group
时间窗: 48 hours
hemorrhagic transformation detected by brain imaging CT and/or MRI brain will be done after 2 days of onset
amount of peripheral bleeding within 48 hours of loading anti platelet in each group
时间窗: 48 hours
amount of peripheral bleeding measured in milliliter in each group
frequency of peripheral bleeding within 48 hours of loading anti platelet in each group
时间窗: 48 hours
amount of peripheral bleeding measured as ( time per day )
次要结局
- Mortality in each group(3 months)
- 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)
研究者
Mohamed zeinhom Gomaa
principal investigator
Kafrelsheikh University