NL-OMON50593已完成3 期
A Randomized, Double-Blind, Placebo-Controlled Trial Investigating The Effect Of Ticagrelor On Saphenous Vein Graft Patency In Patients Undergoing Coronary Artery Bypass Grafting Surgery. - POPular CABG
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 499
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) More than 21 years of age, 2) Planned CABG with the use of 1 or more SVGs
排除标准
- •1) Unable to give informed consent or a life expectancy of less than 1 year, 2)
- •Concomitant valve (excluding aortic bioprothesis), aorta or rhythm surgery
- •during the same session, 3) Inability to undergo CCTA, in the investigator*s
- •opinion, for instance due to severe claustrophobia or contrast allergy, 4) Use
- •of oral anticoagulants (acenocoumarol, fenprocoumon, NOACs) and a
- •contraindication for discontinuation of this medication or the expectation that
- •the patient will have an indication for the use of these drugs after surgery ,
- •5) Placement of a drug-eluting stent in a coronary or cerebral artery within 6
- •months of CABG or placement of a bare-metal stent in a coronary or cerebral
- •artery within 1 month of CABG , 6) Use of other antiplatelet drugs than ASA
- •(clopidogrel, prasugrel, ticagrelor, dypiridamol, etc.) and a contraindication
- •for discontinuation of this medication after CABG, according to the treating
- •physician or the investigator, 7) Women who are known to be pregnant, who have
- •given birth within the past 90 days or who are breastfeeding, 8) Pre-menopausal
- •women without adequate contraception, 9) Severe renal function impairment
- •requiring dialysis , 10) Moderate or severe hepatic impairment, 11) Active
- •malignancy with increase in bleeding risk, in the investigator*s opinion, 12)
- •Use of strong inhibitors of CYP3A4 (e.g. ketaconazole, claritromycin,
- •nefazodone, ritonavir, atazanavir), 13) Clinically significant out of range
- •values for platelet count or haemoglobin at screening, in the investigator*s
- •opinion., 14) Contraindication for the use of ticagrelor or ASA (i.e. history
- •of intracranial bleeding, high bleeding risk, previous allergic reaction), in
- •the investigator*s opinion, 15) Previous randomization in this study
研究者
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