EUCTR2013-004376-35-GR进行中（未招募）1 期
A Single Center, Phase II, Assessor-Blinded, RaNdomized, Active Controlled, Parallel-Group Trial to COmpare Ticagrelor Versus Clopidogrel on the REduction of ArteriaL STiffness and Wave Reflections in Patients with CoronarY Artery Disease. The ‘NOVELTY’ Study - NOVELTY
Hellenic Cardiovascular Research Society0 个研究点目标入组 60 人开始时间: 2013年11月15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
- 60
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
入选标准
- •- Provision of informed consent prior to any study specific procedures.
- •-?ale and female subjects > 18 and < 79 years of age.
- •- Indication for elective coronary angiography (angina, positive stress test/SPECT/stress echo) with or without PCI for inclusion in the ‘acute’ study period, and indication for either ad hoc or elective PCI for inclusion in the ‘chronic’ study period.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.Subjects who had ACS within 12 months of screening.
- •2.Previous stent implantation with dual antiplatelet therapy within 12 months of screening.
- •3.Subjects being treated with anti-platelet medications other than aspirin prior to diagnostic catheterization including glycoprotein IIb/IIIa inhibitors.
- •4.Subjects with NYHA class III or IV heart failure or known left ventricular ejection fraction < 30%.
- •5.Subjects with hemodynamic or electrical instability (including shock).
- •6.History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
- •7.Other bleeding diathesis, or considered by Investigator to be at high risk for bleeding.
- •8.Any previous history of ischemic or hemorrhagic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
- •9.International Normalized Ratio (INR) known to be >1.5 within 1 week of study entry.
- •10.Poorly controlled blood pressure (>160/100 mmHg).
- •11.Known platelet count of <100,000/mm3 within 1 week of study entry.
- •12.Known anemia (hemoglobin [Hb] <10 gr/dL) within 1 week of study entry.
- •13.Subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study.
- •14.Severe kidney disease (GFR<30 ml/min/1.73m2).
- •15.Hepatic insufficiency defined as liver cirrhosis, AST/ALT/Alkaline Phosphatase greater than 3 times the upper limit of normal or hyperbilirubinemia defined as peak total serum bilirubin greater than 2 times the upper limit of normal (ULN).
- •16.Any indication (atrial fibrillation, mitral stenosis or prosthetic heart valve, pulmonary embolism (PE), deep vein thrombosis (DVT)) for anticoagulation treatment during study period.
- •17.Asthma or chronic obstructive pulmonary disease requiring brochodilating agents.
- •18.Concomitant use of potent Cytochrome P450 3A4 (CYP3A4) inhibitors (atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) or inducers (carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, and rifapentine).
- •19.Concomitant use of drugs that are metabolized through CYP2C19 (omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine, oxcarbazepine and chloramphenicol).
- •20.History of uric acid nephropathy and high levels of uric acid within 1 week of study entry.
- •21.Increased risk of bradycardic events (e.g. known sick sinus syndrome or third degree AV block or previous documented syncope suspected to be due to bradycardia unless treated with a pacemaker).
- •22.Known neoplastic or autoimmune disease or any concomitant medical illness that in the opinion of the Investigator may interfere with or prevent completion in this study.
- •23.Contraindication to clopidogrel, ASA, or ticagrelor.
- •24.A history of alcohol and/or substance abuse that could interfere with conduct of the trial.
- •25.Pregnancy or lactation
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