ISRCTN17514416进行中（未招募）4 期
A RandomizEd trial of two diFferent antIplatelet strategies in patieNts with acutE coronary syndromes planned for Coronary Artery Bypass Graft surgery - the REFINE CABG study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Provision of informed consent prior to any study-specific procedures
- •2. Male or female aged 18 years or over
- •3. Currently hospitalised for treatment of an acute coronary syndrome
- •4. Currently receiving aspirin 75 mg once daily
- •5. Current treatment or prior treatment during the current hospitalisation with ticagrelor 90 mg twice daily
- •6. Currently being considered for CABG surgery during the current hospitalisation following coronary angiography with plan to stop ticagrelor approximately 5 days before surgery
排除标准
- •1. CABG surgery planned to occur urgently either less than 3 days after cessation of ticagrelor or less than 5 days after cessation of ticagrelor without guidance by platelet function testing
- •2. Treatment within the last 7 days or planned treatment with any antiplatelet drug other than aspirin and ticagrelor (including prasugrel, clopidogrel, dipyridamole, cilostazol, or glycoprotein IIb/IIIa antagonists) except for a short course of a glycoprotein IIb/IIIa antagonist (tirofiban or eptifibatide) as bridging therapy in those discontinuing ticagrelor at least 3 days prior to scheduled CABG surgery
- •3. Current or planned treatment prior to CABG surgery with oral or parenteral anti-inflammatory/immunomodulatory drugs (oral corticosteroids; disease-modifying anti-rheumatic drugs, including methotrexate at any dose; immunosuppressants; chemotherapy drugs), oral anti-coagulant medications (warfarin, dabigatran, rivaroxaban, edoxaban, apixaban) or intravenous fibrinolytic agents
- •4. Current or planned treatment prior to CABG surgery with a non-steroidal anti-inflammatory drug other than aspirin
- •5. Known hypersensitivity to or intolerance of aspirin, salicylic acid (including certain asthma patients who may suffer an asthma attack or faint), ticagrelor or excipients
- •6. Clinically significant liver disease, defined as a known or suspected diagnosis of hepatic cirrhosis with current Child-Pugh class B or C; or elevation of serum alanine transferase or aspartate transferase greater than 3 times the upper limit of the normal range for the processing laboratory on blood tests performed during the current hospitalisation
- •7. Abnormal full blood count on blood tests performed during the current hospitalisation that, in the opinion of the investigator, would preclude safe involvement in the study or compromise its scientific credibility
- •8. Evidence of active pathological bleeding
- •9. Participants with clinically significant co-morbidity that, in the opinion of the investigator, would preclude safe involvement in the study or compromise its scientific credibility
- •10. Any clinically significant abnormal laboratory test results during the current hospitalisation that, in the opinion of the investigator, would preclude safe involvement in the study
- •11. Pregnant or breastfeeding women
- •12. Known haemorrhagic diathesis or coagulation disorders such as haemophilia or moderate or severe thrombocytopenia (platelet count < 100 x 10 9/L)
- •13. Current treatment with a strong CYP3A inhibitor or inducer
- •14. Current treatment with doses of simvastatin or lovastatin >40 mg/day or CYP3A substrates with a narrow therapeutic index
- •15. Any other contraindication for ticagrelor or aspirin treatment as detailed in the respective SmPCs
- •16. Women of child-bearing potential (WOCBP) unless negative pregnancy test at screening and willing to use highly-effective contraception for the duration of treatment with study medication
研究者
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