CTRI/2021/06/034322已完成3 期
A Prospective, Multicenter, Randomized, Comparative, Parallel Group Clinical Study to Compare The Efficacy, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Intravenous Injection of Tenecteplase (Hetero Biopharma Limited) and Reference Medicinal Product (RMP-Tenecteplase, Boehringer Ingelheim) in Adults for the Thrombolytic Treatment of Suspected Myocardial Infarction with Persistent ST Elevation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 198
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
- •1. Adult male or female patients of age 18-65 years (both inclusive)
- •2. Patient 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
- •3. Patient presenting with chest pain and/or symptoms of Acute Myocardial Infarction with ST elevation in at least 2 or more contiguous leads (12 Lead ECG) with the following:
- •a. ST elevation of =0.25 mV in men <40 years or =0.2 mV in men =40 years or =0.15 mV in women in leads V2-V3
- •b. ST elevation of =0.1 mV in other contiguous chest leads or limb leads
- •4. Patient presenting with AMI within 6 hours of occurrence of symptoms
- •5. Female patient of childbearing potential must agree to get pregnancy test done at the time of enrolment and it should be negative.
排除标准
- •1. Patient with new onset Left Bundle Branch Block (LBBB)
- •2. Patient with history/evidence of hypersensitivity to thrombolytics or any of the components of formulation including gentamicin
- •3. Patient planned for primary percutaneous coronary intervention (PCI).
- •4. Patient receiving oral anticoagulant treatments with INR >1.3
- •5. Patient with history of prolonged cardiopulmonary resuscitation ( >2 minutes) within the past 2 weeks
- •6. Patient with history/ active internal bleeding disorder within 6 months
- •7. Patient with history of recent gastrointestinal or genitourinary bleeding (within the past 10 days)
- •8. Patient with known hemorrhagic diathesis
- •9. Patient with known history of hemorrhagic stroke or stroke of unknown origin
- •10. Patient with history of ischemic stroke or transient ischemic attack in the preceding 6 months
- •11. Patient with history of intracranial tumor, arteriovenous malformation, cerebral aneurysm, intracranial or spinal surgery
- •12. Patient of known arterial/venous malformations
- •13. Patient with history of trauma to the head or cranium within 6 months
- •14. Patient with history of major surgery, parenchymal biopsy, ocular surgery and/or significant trauma within the past 2 months (this includes any trauma associated with the current AMI).
- •15. Patient of uncontrolled hypertension of systolic BP >160 mm of Hg and diastolic BP >110 mm of Hg
- •16. Patient administered Tenecteplase in the last 14 days prior to screening.
- •17. Patient administered of any glycoprotein IIb/IIIa inhibitor (including abciximab, eptifibatide, sibrafiban and tirofiban) in the 24 hours prior to screening.
- •18. Patient with subacute bacterial endocarditis and clinical pericarditis including pericarditis after this episode of acute myocardial Infarction.
- •19. Patient with high risk as per TIMI risk scoring.
- •20. Where, in the opinion of the investigator, participation in this study will not be in the best interest of the patient, or any other circumstances that prevent the patient from participating in the study safely.
研究者
相似试验
进行中（未招募）
3 期
A clinical research to study the safety, efficacy and immunogenicity of test pertuzumab in metastatic breast cancer patients.CTRI/2023/05/052997Enzene Biosciences Limited
已完成
3 期
Safety, Efficacy, Pharmacokinetics, and Immunogenicity of Test Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,)CTRI/2022/03/041271Zydus Research Centre Cadila Healthcare Limited268
已完成
3 期
Safety and efficacy Assessment of Trastuzumab emtansine of Cadila Healthcare Ltd in comparison with Reference drug(Trastuzumab emtansine) for the treatment of metastatic breast cancerCTRI/2018/07/014881Cadila Healthcare Ltd168
已完成
2 期
Clinical study on AP/VJT/SBO Ayurvedic Hair Oil in femalesCTRI/2022/05/042393AYURVED PRATISTHA
招募中
3 期
A clinical phase III trial to study and compare the effects of human Recombinant PTH in post menopausal female with OsteoporosisCTRI/2009/091/000293Intas Biopharmaceuticals Limited120