NCT02725099已完成4 期
Chewing Versus Traditional Oral Administration of Ticagrelor in ST-elevation Myocardial Infarction Patients - A Platelet Reactivity Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD
研究概览
简要总结
To examine chewing versus traditional oral administration of ticagrelor in ST-elevation Myocardial Infarction (STEMI) patients on platelet reactivity.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with STEMI
- •Informed, written consent
排除标准
- •Age < 18 years or Age > 90 years
- •Active bleeding; bleeding diathesis; coagulopathy
- •Increased risk of bradycardic events
- •History of gastrointestinal or genitourinary bleeding <2 months
- •Major surgery in the last 6 weeks
- •History of intracranial bleeding or structural abnormalities
- •Suspected aortic dissection
- •Any other condition that may put the patient at risk or influence study results or investigator's opinion (severe hemodynamic instability, unconsciousness, known malignancies or other comorbid conditions with life expectancy <1 year)
- •Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux.
- •Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers, CYP3A with narrow therapeutic windows
- •Known relevant hematological deviations: Hb <10 g/dl, PLT<100x10^9/l
- •Use of coumadin derivatives within the last 7 days
- •Chronic therapy with ticagrelor, prasugrel, clopidogrel or ticlopidine
- •Known severe liver disease, severe renal failure
- •Known allergy to the study medications
- •Human immunodeficiency virus treatment
- •The use of IIBIIIA receptor antagonists in the 48 hours before enrollment (if abciximab use then in the last 14 days).
- •If the patients cannot sign percutaneous coronary intervention (PCI) informed consent for any reason.
研究组 & 干预措施
Oral Ticagrelor
Active Comparator
干预措施: Oral Ticagrelor (Drug)
Chewing Ticagrelor
Experimental
干预措施: Chewing Ticagrelor (Drug)
结局指标
主要结局
Residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD
时间窗: 1 hour
次要结局
- The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour, 4-6 hours after ticagrelor LD(1, 4-6 hours)
- Occurrence of dyspnea and/or symptomatic bradycardia(30 days)
- Major, minor, minimal bleeding [ Thrombolysis in Myocardial Infarction (TIMI) criteria] events(30 days)
研究者
Dr. Elad Asher
MD
Sheba Medical Center
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
Chewing Ticagrelor Versus Prasugrel in ST-elevation Myocardial Infarction - A Platelet Reactivity StudyAcute Coronary SyndromeSTEMINCT03016611Sheba Medical Center100
已完成
4 期
Sub Lingual Versus Traditional Oral Administration of Ticagrelor in Acute Coronary Syndrome/Non ST-elevation Myocardial Infarction - A Platelet Reactivity StudyAcute Coronary SyndromesNon ST Elevation Myocardial InfarctionNCT02402400Sheba Medical Center50
已完成
1 期
Study to Investigate if the Uptake of Ticagrelor Into the Body Differs Depending on Method of Administration.Bioavailability Heathy VolunteersNCT01887626AstraZeneca36
Unknown
4 期
Ticagrelor and Clopidogrel on Platelet Aggregation in Clopidogrel Resistance's Patients With CHDPlatelet ReactivityNCT03614832First Affiliated Hospital of Harbin Medical University100
进行中（未招募）
1 期
The Effect of Intravenous Cangrelor vs oral Ticagrelor on Heart Muscle Damage in Patients with Major Heart Attack.MedDRA version: 18.1Level: PTClassification code 10053460Term: Antiplatelet therapySystem Organ Class: 10042613 - Surgical and medical proceduresAcute myocardial infarctionEUCTR2016-000195-19-GBThe Royal Wolverhampton NHS Trust100