CTRI/2021/09/036641尚未招募未知
A Prospective, Randomized, Comparative, Parallel Group Clinical Study to Compare the Pharmacokinetics, Fibrinolytic Activity and Safety of Intravenous Injection of Tenecteplase (Hetero Biopharma Limited) and Reference Medicinal Product (RMP Tenecteplase, Boehringer Ingelheim) in Adults with suspected myocardial infarction with persistent ST elevation.
PSK Pharma LLC0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients and willing to provide written informed consent. 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
- •- Patients presenting with chest pain and/or symptoms of Acute Myocardial Infarction confirmed by physician with the following ECG changes (12 lead).
- •a ST elevation of >0.1 mV in two or more limb leads or
- •b ST elevation of >0.2 mV in two or more contiguous precordial leads
- •- Subjects presenting with AMI within 6 hours of occurrence of symptoms
- •- Women of childbearing potential must agree to get pregnancy test done at the time of enrolment and it should be negative.
排除标准
- •- Patients with Left Bundle Branch Block (LBBB).
- •- Patients contraindicated or with history/evidence of hypersensitivity to thrombolytics or any of the components of formulation.
- •- Patients with history/ active internal active bleeding or hemorrhagic diathesis
- •- Any known history of hemorrhagic stroke or stroke of unknown origin
- •- Any history of ischemic stroke or transient ischemic attack in the preceding 6 months
- •- History of intracranial tumor, arteriovenous malformation, cerebral aneurysm, major surgery, parenchymal biopsy, ocular surgery and/or significant trauma within the past 2 months (this includes any trauma associated with the current AMI).
- •- Uncontrolled hypertension of systolic BP > 200 mm of Hg and diastolic BP >110 mm of Hg
- •- Patients administered Tenecteplase in the last 14 days prior to screening for study.
- •- Patients administered of any glycoprotein IIb/IIIa inhibitor (including abciximab, eptifibatide, sibrafiban and tirofiban) in the 24 hrs prior to screening for study.
- •- Patients with subacute bacterial endocarditis and clinical pericarditis including pericarditis after this episode of acute myocardial Infarction.
- •- Patients with high risk as per TIMI risk scoring.
- •- Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely
- •- Patients with severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
- •- Patients with any other condition like active peptic ulceration, acute pancreatitis, which investigator feels would pose a significant hazard to subject if IP is administered
研究者
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