CTRI/2020/07/026356进行中（未招募）4 期
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
- 4 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. 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.
- •2. Patients presenting with AMI within 6 hours of onset of symptoms.
- •3. Women of childbearing potential should have a negative pregnancy test and be taking adequate birth control measures.
- •4. 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
- •1. Known history of an anaphylactic (i.e. life-threatening) reaction to any of the constituents (i.e. tenecteplase or any excipient)
- •2. 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
- •4. Patients on oral anticoagulant treatment
- •5. Internal active bleeding or known history of hemorrhagic diathesis
- •6. Hypertension with systolic BP > 180 mmHg and/or diastolic BP > 110 mmHg during current admission prior to enrolment
- •7. Cardiogenic shock (Systolic BP < 60 mm Hg)
- •8. Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current AMI)
- •9. Recent trauma to the head or cranium within 1 year
- •10. Prolonged cardiopulmonary resuscitation ( > 2 minutes) within the past 2 weeks
- •11. Patients with acute pericarditis and/or subacute bacterial endocarditis
- •12. Patients with severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
- •13. Patients with arterial aneurysm or known arterial/venous malformation, active peptic ulceration, acute pancreatitis, neoplasm with increased bleeding risk, or dementia
- •14. Known history of haemorrhagic stroke or stroke of unknown origin
- •15. Known history of ischaemic stroke or transient ischaemic attack in the preceding 6 months
- •16. Pregnancy or lactation, or parturition within the previous 30 days. Women of childbearing potential must have a negative pregnancy test.
- •17. Known participation in another investigative drug study or investigative device protocol within the previous 3 months
- •18. Any other condition which investigator feels would pose a significant hazard to patient if tenecteplase is administered.
研究者
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