EUCTR2012-003630-16-AT进行中（未招募）1 期
A Randomized, Parallel Group, Double-Blind Study of Ticagrelor Compared with Aspirin for Prevention of Vascular Events in Patients Undergoing Coronary Artery Bypass Graft OperationTiCAB– Ticagrelor in CABG - TiCAB
German Heart Centre Munich, Department of0 个研究点目标入组 3,850 人开始时间: 2013年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,850
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patients 18 years of age or older
- •2.Informed, written consent by the patient
- •3. Indication for CABG surgery:
- •- coronary three vessel disease, or
- •- left main stenosis, or
- •- two vessel disease with impaired left ventricular function (<50%)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1925
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1925
排除标准
- •1. Cardiogenic shock, haemodynamic instability
- •2. Indication for oral anticoagulation or dual antiplatelet therapy that
- •cannot be stopped after CABG
- •3. Need for concomitant non-coronary surgery (e.g. valve replacement)
- •4. Contraindication for ASA or Ticagrelor use (e.g. known allergy)
- •5. Intolerance of or allergy to Ticagrelor or ASA or any of their excipients
- •6. History of bleeding diathesis within three months prior presentation,
- •7. History of significant gastrointestinal bleed within 6 months prior
- •presentation
- •8. History of intracranial hemorrhage
- •9. History of moderate to severe liver impairment (Child Pugh B or C)
- •10. Chronic renal insufficiency requiring dialysis
- •11. Patient with an increased risk of bradycardic events (e.g. patients
- •without a pacemaker who have sick sinus syndrome, 2nd or 3rd degree
- •AV block or bradycardic-related syncope)
- •12. Known, clinically important thrombocytopenia (e.g. <100.000/µl)
- •13. Known, clinically important anaemia (e.g. <10g/dl)
- •14. Participation in another investigational drug or device study in the
- •last 30 days
- •15. Pregnancy or lactation (for premenopausal women 2 methods of
- •reliable contraception, one of which must be barrier method, are
- •required); in women with childbearing potential a pregnancy test is
- •16. Concomitant oral or intravenous therapy (see examples below) with
- •strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic
- •indices, or strong CYP3A inducers which cannot be stopped for the
- •course of the study
- •o Strong inhibitors: ketoconazole, itraconazole, voriconazole,
- •telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir,
- •nelfinavir, indinavir, atanazavir, over 1 liter daily of grapefruit juice.
- •o Substrates with narrow therapeutic index: cyclosporine, quinidine.
- •o Strong inducers: rifampin/rifampicin, phenytoin, carbamazepine.
- •17. Life expectancy less than 12 months that may result in protocol noncompliance
- •or a risk for being lost to follow up, active cancer
- •18. Indication for major surgery (e.g. cancer treatment, carotid surgery,
- •cerebral surgery, major vascular surgery)
- •19. Previous enrolment or randomization of treatment in the present
研究者
相似试验
进行中（未招募）
3 期
A Randomized, Parallel Group, Double-Blind Study of Ticagrelor Compared with Aspirin for Prevention of Vascular Events in Patients Undergoing Coronary Artery Bypass Graft OperationTiCAB– Ticagrelor in CABGMedDRA - Cardiovascular Diseases [C14], 14.1 100000004866 10003601 Atherosclerosis LLTI20-I25Ischaemic heart diseasesDRKS00004917Klinik für Herz- und KreislauferkrankungenDeutsches Herzzentrum MünchenKlinik an der Technischen Universität München1,893
进行中（未招募）
1 期
A Randomized, Parallel Group, Double-Blind Study of Ticagrelor Compared with Aspirin for Prevention of Vascular Events in Patients Undergoing Coronary Artery Bypass Graft OperationTiCAB– Ticagrelor in CABGTicagrelor Compared with Aspirin for Prevention of Vascular Events in Patients Undergoing Coronary Artery Bypass Graft OperationMedDRA version: 20.0Level: LLTClassification code 10003601Term: AtherosclerosisSystem Organ Class: 100000004866EUCTR2012-003630-16-DEGerman Heart Centre Munich, Department of3,850
未知
2 期
A Randomized, Double-Blind, Parallel-Group Study of SMP-986 in Patients with Overactive Bladder [Phase 2 Study]Overactive bladderJPRN-jRCT2080221224Dainippon Sumitomo Pharma Co., Ltd.320
进行中（未招募）
1 期
Study of ADVAIR DISKUS and FLOVENT DISKUS taken twice daily in children during fall viral season.AsthmaEUCTR2015-004887-13-Outside-EU/EEAGlaxoSmithKline Research & Development Ltd339
尚未招募
2 期
To Compare the safety and efficacy of Vitamin D, with Magnesium in mild to moderate Covid 19 patientsCTRI/2020/06/026189Suraksha Pharma Private Limited