CTRI/2020/07/026356进行中（未招募）Unknown
A prospective, multi-centre, phase IV study to evaluate safety and efficacy of TenecteRelTM (tenecteplase manufactured by Reliance Life Sciences Pvt. Ltd.)
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 202
- 试验地点
- 12
- 主要终点
- Incidence of treatment emergent adverse events occurring during the study
研究概览
简要总结
This is a prospective, multi-centre, phase IV study to evaluate safety and efficacy of TenecteRelTM in patients with ST segment elevation Myocardial Infarction (STEMI) or new onset left bundle branch block.
TenecteRelTM has been approved for use in adults for thrombolytic treatment of suspected myocardial infarction with persistent ST segment elevation (STEMI) or recent left Bundle Branch Block within 6 hours after the onset of acute myocardial infarction (AMI) symptoms.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •ST-segment elevation ≥ 0.1 mV in two or more limb leads or > 0.2 mV in two or more contiguous precordial leads indicative of AMI, or new onset left bundle-branch block.
- •Patients presenting with AMI within 6 hours of onset of symptoms.
- •Women of childbearing potential should have a negative pregnancy test and be taking adequate birth control measures.
- •Consent from Legally Acceptable Representative (LAR), if patient is not in the condition to give consent.
- •However, when the patient is stable and is able to give consent, consent would be obtained to confirm his/her willingness to continue in the study.
排除标准
- •Known history of an anaphylactic (i.e. life-threatening) reaction to any of the constituents (i.e. tenecteplase or any excipient)
- •Use of Abciximab or other marketed GPIIb/IIIa antagonists within the preceding 24 hours 3.Significant bleeding disorder either at present or within the past 6 months
- •Patients on oral anticoagulant treatment
- •Internal active bleeding or known history of hemorrhagic diathesis
- •Hypertension with systolic BP > 180 mmHg and/or diastolic BP > 110 mmHg during current admission prior to enrolment
- •Cardiogenic shock (Systolic BP < 60 mm Hg)
- •Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current AMI)
- •Recent trauma to the head or cranium within 1 year
- •Prolonged cardiopulmonary resuscitation (> 2 minutes) within the past 2 weeks
- •Patients with acute pericarditis and/or subacute bacterial endocarditis
- •Patients with severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
- •Known history of haemorrhagic stroke or stroke of unknown origin
- •Known history of ischaemic stroke or transient ischaemic attack in the preceding 6 months
- •Pregnancy or lactation, or parturition within the previous 30 days.
- •Known participation in another investigative drug study or investigative device protocol within the previous 3 months
- •Any other condition which investigator feels would pose a significant hazard to patient if tenecteplase is administered.
结局指标
主要结局
Incidence of treatment emergent adverse events occurring during the study
时间窗: Incidence of treatment emergent adverse events occurring during the study
次要结局
- Thirty-day mortality, defined as death at or before 30 days after enrollment(-‘Net clinical benefit’ defined as the absence of mortality and non-fatal stroke at 30 days)
研究者
研究点 (12)
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