EUCTR2016-002586-64-GR进行中（未招募）1 期
A randomized, pharmacodynamic study of cangrelor administration in STEMI patients loaded with ticagrelor
ELKE University of Athens0 个研究点开始时间: 2016年9月23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
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
- •For patients included in the study must meet the following criteria:
- •1. Provide signed inform consent form for any procedure that involves the study
- •2. Patients with STEMI (ST segment elevation in at least two leads,> 2mm the precordial or> 1mm in inferior leads and new or suspected new-onset LBBB) who are going to perform primary angioplasty
- •3. Not receiving inhibitor of P2Y12 receptor
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Patients will be excluded from the study if they met any of you following exclusion criteria:
- •1. Known hypersensitivity reaction to tikagkrelor or kangkrelor or to any of excipients.
- •2. Haemorrhagic diathesis: active pathological bleeding, serious hemorrhagic disorder, history of stroke or intracranial hemorrhage, mass lesion of the CNS or intracranial vascular disorder. Also gastro-intestinal bleeding within the last 6 months or major surgery in the last 30 days
- •3. Chronic anticoagulant therapy,
- •4. Recent angioplasty or coronary bypass surgery <3 months, low platelet count <100 000 / L,
- •5. Hematocrit <30%
- •6. creatinine clearance <30mL / min,
- •7. Severe hepatic dysfunction,
- •8. Use of potent inhibitors (amiodarone, erythromycin, fluconazole, miconazole, diltiazem, verapamil, delavirdine, amprenavir, fosamprenavir, conivaptan, clarithromycin, itraconazole, ketoconazole) or inducers of CYP3A (Carbamazepine, Dexamethasone, Glucocorticoids, Phenytoin Primidone, Progesterone, Phenobarbital, Sulfinpyrazone, Troglitazone)
- •9. Increased risk of bradycardia (eg, sick sinus syndrome or third degree atrioventricular block or documented preceding syncope probably due to bradycardia unless treated with pacemaker implantation).
- •10. Severe chronic obstructive pulmonary disease,
- •11. Peri-procedural administration IIb / IIIa inhibitors.
- •12. patient anable to attend the required follow-up or any other cause or condition makes the researcher to believe that the initiation of therapy under study would put the patient at increased risk
研究者
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