IRCT20190729044366N1招募中3 期
A randomized, double-blind , parallel groups, multi center, non-inferiority and phase III clinical trial to compare the Efficacy and Safety of Altelyse (bio-similar Alteplase) versus the brand Actilyse in Acute MI patients with ST elevation
Arena Life Science Company0 个研究点目标入组 150 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
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 years 至 no limit（—）
- 性别
- All
入选标准
- •Chest pain compatible with ischemic heart disease for more than 20 minutes
- •Start of symptoms of Acute Myocardial Infarction (Peak of chest pain) 12 hours (Maximum) before thrombolytic treatment
- •Signs of Acute Myocardial Infarction in Electrocardiogram: ST elevation of 0.1 mili-volt or more in two adjacent leads other than v2 and v3; ST elevation of 0.25 mili-volt or more in v2 and v3 leads in men younger than 40 years; ST elevation of 0.2 mili-volt or more in v2 and v3 leads in men older than 40 years; ST elevation of 0.15 mili-volt or more in v2 and v3 leads in women irrespective of their age.
- •Lack of access to cath lab to do PPI, Primary Per-cutaneous Coronary Intervention or expecting a delay more than 2 hours between between first medical contact and performance of first balloon dilatation excluding the time takes from first medical contact till the start of thrombolytic therapy.
- •Signed informed consent
- •Age of 18 years or more
排除标准
- •Presence of left bundle block in electrocardiogram
- •Presence of accompanying severe diseases such as renal failure (GFR<30); hepatic failure; POrtal hypertension; Hepatitis; Thrombocytopaenia; Known pancreatitis (information gathered from first clinical examination upon arrival because of cheat pain
- •Cardiogenic shock (Systolic pressure less than 90 mm Hg)
- •Killip class III & IV
- •Any history of intracranial bleeding or stroke with unknown origin irrespective of the time of occurrence
- •Ischemic stroke
- •Known central nervous system lesions, neoplasms (primary or metastatic), arteriovenous malformations
- •Aortic dissection
- •Active bleeding or known bleeding disorder (excluding menses)
- •Major trauma to Head and Neck in the last 3 months
- •Intracranial or spinal surgery in the last 2 months
- •Other major trauma or surgery within the preceding month
- •Gastrointestinal bleeding within the preceding month
- •Sever uncontrolled hypertension (Resistant to emergency treatment)
- •Non-compressible punctures in the past 24 hours (e.g. liver biopsy, lumbar puncture)
- •History of poorly controlled chronic hypertension
- •Hypertension at the time of eligibility assessment: Systolic BP >180 mm Hg or diastolic BP > 110 mm Hg
- •Transient ischemic attack in the preceding 6 months
- •Pregnancy or within 1 week postpartum
- •Internal bleeding within the last 2-4 weeks
- •Active peptic ulcer
- •Infectious endocarditis
- •Cardiopulmonary resuscitation that has caused injury to the chest or lasted more than 10 minutes
- •Patients who receive anticoagulant therapy such as warfarin
- •Advanced liver disease
- •Known intracranial lesions other than those listed as absolute contraindications for thrombolytic therapy
- •Diabetic Hemorrhagic Retinopathy or other hemorrhagic ophthalmic conditions
研究者
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