跳至主要内容
临床试验/CTRI/2016/07/007090
CTRI/2016/07/007090已完成4 期

Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention

ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI0 个研究点目标入组 610 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
610

研究概览

简要总结

暂无简介。

研究设计

研究类型
Pms

入排标准

入选标准

  • Clinical Inclusion Criteria (MUST MEET AT LEAST ONE):
  • 1. Adult patients >= 65 years of age
  • 2. Female gender
  • 3.Troponin positive acute coronary syndrome
  • 4. Established vascular disease defined as previous MI, documented PAD or CAD/PAD revascularization
  • 5. Diabetes mellitus treated with medications (oral hypoglycemic, subcutaneous injection of insulin)
  • 6. Chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2 or creatinine clearance (CrCl) < 60 ml/min
  • Angiographic Inclusion Criteria (MUST MEET AT LEAST ONE):
  • 7. Multivessel coronary artery disease
  • 8.Target lesion requiring total stent length >30 mm
  • 9.Thrombotic target lesion(s)
  • 10.Bifurcation lesions with Medina X,1,1 classification requiring at least 2 stents
  • 11. Left main (>=50%) or proximal LAD (>=70%) lesion
  • 12. Calcified target lesion(s) requiring atherectomy

排除标准

  • Exclusion Criteria:
  • 1.Under 18 years of age
  • 2.Contraindication to aspirin
  • 3. Contraindication to ticagrelor
  • 4. Planned surgery within 90 days
  • 5. Planned coronary revascularization (surgical or percutaneous) within 90 days
  • 6.Need for chronic oral anticoagulation
  • 7.Prior stroke
  • 8.Dialysis-dependent renal failure
  • 9.Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a raised risk for bleeding, malignancies with a raised risk for bleeding)
  • 10.Salvage PCI or STEMI presentation.
  • 11.Liver cirrhosis
  • 12.Life expectancy < 1 year
  • 13.Unable or unwilling to provide informed consent
  • 14.Women of child bearing potential (as determined by hospital standard of care)
  • Fibrinolytic therapy within 24 hours of index PCI
  • 15. Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer
  • 16.Platelet count < 100,000 mm3
  • 17.Requiring ongoing treatment with aspirin >= 325 mg daily

研究者

相似试验

进行中(未招募)
1 期
TWILIGHT Study: Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention.Bleeding among high-risk patients with Percutanous coronary intervention with at least one drug-eluting stent.MedDRA version: 18.1Level: PTClassification code 10065608Term: Percutaneous coronary interventionSystem Organ Class: 10042613 - Surgical and medical procedures
EUCTR2014-005498-35-GBMount Sinai9,000
已完成
4 期
Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary InterventionInterventional CardiologyCardiovascular Disease
NCT02270242Icahn School of Medicine at Mount Sinai9,006
进行中(未招募)
1 期
TWLIGHT Study - Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Interventio
EUCTR2014-005498-35-PLThe Office of Interventional Cardiovascular Research and Clinical Trials at Icahn School of Medicine at Mount Sinai9,000
进行中(未招募)
1 期
TWILIGHT Study - Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary InterventioBleeding among high-risk patients with percutanous coronary intervention with at least one drug-eluting stentMedDRA version: 20.0Level: PTClassification code 10065608Term: Percutaneous coronary interventionSystem Organ Class: 10042613 - Surgical and medical procedures
EUCTR2014-005498-35-DEThe Office of Interventional Cardiovascular Research and Clinical Trials at Icahn School of Medicine at Mount Sinai9,000
进行中(未招募)
1 期
TWILIGHT Study - Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Interventio
EUCTR2014-005498-35-ATThe Office of Interventional Cardiovascular Research and Clinical Trials at Icahn School of Medicine at Mount Sinai9,000
TWILIGHT Study The anti platelet therapy with both... | 临床试验