EUCTR2014-004082-25-GR进行中（未招募）1 期
A multicenter, prospective, randomized, open label, blinded endpoint, active-comparator trial to assess the MIcrovascular integrity and left ventricular function Recovery after clopidogrel or TicagrelOr administration, in patients with STEMI treated with thrombolysis - The ‘MIRTOS’ Study - MIRTOS
Hellenic Cardiovascular Research Society0 个研究点目标入组 358 人开始时间: 2015年5月8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
- 358
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
- •1) Provision of informed consent prior to any study specific procedures.
- •2) Male and female subjects, 18-75 years of age (both inclusive).
- •3) STEMI eligible for thrombolysis
- •4) Inability to perform primary PCI, because of transport time in centers carrying out primary PCI lasting more than two hours
- •5) Ability of transportation in 3-24 hours after thrombolysis in order to perform coronary angiography and PCI. This period may be extended for reasons of extreme importance up to 72 hours at the latest.
- •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 215
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 143
排除标准
- •1)Inability to give informed consent.
- •2)Pre-treatment with any P2Y12 inhibitor within the 7-day period prior to randomization.
- •3)Cardiogenic shock – Killip class 4.
- •4)Suspicion or evidence of mechanical complication, including mitral valve dysfunction, ventricular septal rupture, and rupture of the left ventricle.
- •5)Current use of warfarin or other anticoagulant drug.
- •6)Known multivessel coronary artery disease not suitable for revascularization. 7)Any contraindication to thrombolytic therapy -Central nervous system damage or neoplasms or atrioventricular malformation -Recent major trauma/surgery/head injury (within the preceding 3 weeks) -Gastrointestinal bleeding within the past month -Known bleeding disorder (excluding menses) -Aortic dissection -Non-compressible punctures in the past 24 hours (e.g. liver biopsy, lumbar puncture). 8)Other bleeding diathesis, or considered by Investigator to be at high risk for bleeding.
- •9)Any kind of stroke in the past year or haemorrhagic stroke ever.
- •10)Severe uncontrolled hypertension (>180/110 mmHg) prior to randomisation. 11)Prolonged or traumatic cardiopulmonary resuscitation (> 10 minutes) in the last 2 weeks.
- •12)Known thrombocytopenia defined as platelet count of <100,000/mm3.
- •13)Known anemia (hemoglobin [Hb] <10 gr/dL).
- •14)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.
- •15)Chronic dialysis or known chronic renal failure (glomerular filtration rate (GFR)<30 ml/min/1.73m2).
- •16)Known moderate or severe hepatic impairment.
- •17)Severe uncontrolled chronic obstructive pulmonary disease.
- •18)Concomitant use of potent Cytochrome P450 3A4 (CYP3A4) inhibitors (atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole, grapefruit juice over 1 litre daily), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), 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)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).
- •21)Any known contraindication to clopidogrel, ASA, or ticagrelor.
- •22)Current pregnancy, active lactation or parturition (childbirth) within the previous 30 days; women of childbearing potential must have a negative urine pregnancy test, or use a medically accepted method of birth control.
- •23)Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the completion of study participation.
- •24)Any non-cardiac condition with life expectancy less
研究者
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