TWILIGHT StudyTicagrelor With Aspirin or Alone in High-Risk Patients After CoronaryIntervention - TWILIGHT

INTERVENTIONAL CARDIOVASC. RESEARCH & CLINICAL TRIALS AT ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI0 个研究点目标入组 9,000 人开始时间: 2020年11月5日最近更新: 2021年1月5日

适应症

试验速览

暂无简介。

•Must meet AT LEAST ONE clinical inclusion criterion:
•- Adult patients = 65 years of age
•- Female gender
•- Troponin positive acute coronary syndrome
•- Established vascular disease defined as previous MI, documented PAD or CAD/PAD revascularization
•- Diabetes mellitus treated with medications or insulin
•- Chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2 or creatinine clearance (CrCl) <60 ml/min
•Must meet AT LEAST ONE angiographic inclusion criterion:
•- Multivessel coronary artery disease (CAD)
•- Target lesion requiring total stent length >30mm
•- Thrombotic target lesion(s)
•- Bifurcation lesion(s) with Medina X,1,1 classification requiring at least 2 stents
•- Left main (=50%) or proximal LAD (=70%) lesion
•- Calcified target lesion(s) requiring atherectomy
•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 5400
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3600

•Subjects should not enter the study if any of the following exclusion criteria are met:
•- Under 18 years of age
•- Contraindication to aspirin, as listed in Appendix D
•- Contraindication to ticagrelor, as listed in Appendix E
•- Planned surgery within 90 days
•- Planned coronary revascularization (surgical or percutaneous) within 90 days
•- Need for chronic oral anticoagulation
•- Prior stroke
•- Dialysis-dependent renal failure
•- Active bleeding or extreme-risk for major bleeding (e.g. acute gastrointestinal ulcer or history of chronic gastrointestinal ulceration, gastrointestinal pathology with a raised risk for bleeding, malignancies with a raised risk for bleeding)
•- Salvage PCI or STEMI presentation.
•- Liver cirrhosis
•- Life expectancy < 1 year
•- Unable or unwilling to provide informed consent
•- Women of child bearing potential as defined below:
•A woman is considered of childbearing potential (WOBCP) following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
•- Fibrinolytic therapy within 24 hours of index PCI
•- Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer
•- Platelet count < 100,000 mm3
•- Requiring ongoing treatment with aspirin =325 mg daily

发起方

INTERVENTIONAL CARDIOVASC. RESEARCH & CLINICAL TRIALS AT ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI