NL-OMON54418招募中不适用
Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents versus Everolimus-Eluting Stents in Coronary Artery Disease Patients with Diabetes Mellitus Global (ABILITY Diabetes Global) - ABILITY Diabetes Global
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 451
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Clinical Inclusion Criteria 1. Patient understands the
- •trial requirements and the treatment procedures and provides written informed
- •consent; 2. Age >= 18 years (>= 19 years of age for South Korea and >= 21 years of
- •age for Singapore); 3. Diabetic patients: either: a. Patient with a previous
- •documented diagnosis of diabetes mellitus (Type 1 or Type 2) and currently
- •undergoing pharmacological treatment (oral hypoglycemic agents or insulin) b.
- •Newly diagnosed diabetes: either: i. Fasting plasma glucose (FPG) >=126 mg/dL
- •(7.0 mmol/L). Fasting is defined as no caloric intake for >=8 hours or ii.
- •Two-hour plasma glucose >=200 mg/dL (11.1 mmol/L) following a 75g oral glucose
- •tolerance test or iii. HbA1c level >= 7% (53 mmol/mol) Patients who are newly
- •diagnosed are included even if they are not on pharmacological treatment (oral
- •hypoglycemic agents or insulin) 4. Symptomatic coronary artery disease
- •including chronic stable angina, silent ischemia, and non-ST-segment elevation
- •acute coronary syndrome (NSTE-ACS) 5. Patient is eligible for percutaneous
- •coronary intervention (PCI); Previous PCI (with balloon angioplasty or
- •stenting) is allowed if performed >12 months before index procedure; 6.
- •Patient is willing and able to comply with all protocol-required follow-up
- •evaluations. Angiographic Inclusion Criteria (visual estimate) 7.Presence of >=1
- •de novo coronary artery stenosis >50% in a native coronary artery which can
- •be treated with a stent ranging in diameter from 2.25 to 4.0 mm and can be
- •covered with 1 or multiple stents; and 8. No limitation to the number of
- •treated lesions, number of vessels, or lesion length if the patient is judged
- •eligible for PCI by the treating physician according to the local standard of
排除标准
- •Clinical Exclusion Criteria: 1. Patient lacking capacity
- •(i.e. patient suffering from dementia and others) to provide informed consent
- •2. Patients in cardiogenic shock as defined in appendix A; 3. Patient has known
- •allergy to the study stent system or protocol-required concomitant medications
- •(e.g. aspirin, clopidogrel, prasugrel, ticagrelor, heparin, stainless steel,
- •cobalt, chromium, sirolimus, everolimus, radiographic contrast material) that
- •cannot be adequately pre-medicated; 4. Planned surgery (cardiac and
- •non-cardiac) within 6 months after the index procedure unless the
- •dual-antiplatelet therapy (DAPT) can be maintained throughout the peri-surgical
- •period; 5.Patients undergoing primary percutaneous coronary intervention for
- •ST-segment elevation myocardial infarction (STEMI) 6. Patient is pregnant,
- •nursing, or is a woman of child-bearing potential who is not surgically
- •sterile, < 2 years postmenopausal, or does not consistently use effective
- •methods of contraception; 7. Patient has any other serious medical illness
- •(e.g., cancer, end-stage congestive heart failure) that may reduce life
- •expectancy to less than 12 months; 8. Acute or chronic renal dysfunction (serum
- •creatinine >3.0 mg/dl); 9. Currently participating in another
- •investigational drug or device study. Angiographic Exclusion Criteria: 10.
- •In-stent restenotic lesions; 11. Lesions involving venous or arterial bypass
研究者
相似试验
尚未招募
不适用
Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting Stent Trial: Extended Follow-up StudyCoronary Artery DiseaseJPRN-UMIN000030732Research Institute for Production Development3,196
已完成
不适用
Clinical Trial of Abluminus DES+ Sirolimus Eluting Stent Versus Everolimus-eluting DESCoronary Artery DiseaseDiabetesNCT03399994Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS137
进行中（未招募）
1 期
A comparison of Sirolimus versus Tacrolimus as a delayed treatment of recipients of non heart beating donor kidneys after anti-IL2 monoclonal antibody - Sirolimus vs Tacrolimus for NHBD Kidney Recipients after IL-2 mAbKidney transplantation from non heart beating donors for end-stage renal diseaseEUCTR2006-001265-41-GBewcastle upon Tyne Hospitals NHS Trust60
已完成
不适用
Comparison of de novo sirolimus plus tacrolimus with tacrolimus plus mycofenolic acid in renal transplantatioKidney transplantationUrological and Genital DiseasesISRCTN19991928Shahid Beheshti University of Medical Sciences120
已完成
不适用
Sirolimus Conversions in African-American Renal Transplant RecipientsKidney AbsenceNCT01005706Medical University of South Carolina40