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
- 试验地点
- 21
- 主要终点
- Rate of TIMI grade 3 flow (Thrombolysis In Myocardial Infarction) of the infarct related artery
研究概览
简要总结
This is a multicentric, prospective, double blind, active control, randomized, comparative, parallel, 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 patients with suspected myocardial infarction with persistent ST elevation. Patients will be screened for study eligibility based on the inclusion and exclusion criteria. Patients eligible for the study will be randomized to either Hetero-Tenecteplase or RMP-Tenecteplase based on the randomization schedule. All patients shall be administered on the basis of body weight, with a maximum dose of 10,000 units i.e., 50 mg of tenecteplase. All patients will be followed up for 30 days for efficacy and safety assessments. The study is expected to be completed in approximately 8 - 12 months after dosing of the first patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male or female patients of age 18-65 years (both inclusive)
- •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
- •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 AND/OR b.
- •ST elevation of ≥0.1 mV in other contiguous chest leads or limb leads
- •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
- •Patient with new onset Left Bundle Branch Block (LBBB)
- •Patient with history/evidence of hypersensitivity to thrombolytics or any of the components of formulation including gentamicin
- •Patient planned for primary percutaneous coronary intervention (PCI).
- •Patient receiving oral anticoagulant treatments with INR >1.3
- •Patient with history of prolonged cardiopulmonary resuscitation (>2 minutes) within the past 2 weeks
- •Patient with history/ active internal bleeding disorder within 6 months
- •Patient with known hemorrhagic diathesis
- •Patient with known history of hemorrhagic stroke or stroke of unknown origin
- •Patient with history of ischemic stroke or transient ischemic attack in the preceding 6 months
- •Patient with history of intracranial tumor, arteriovenous malformation, cerebral aneurysm, intracranial or spinal surgery
- •Patient of known arterial/venous malformations
- •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).
- •Patient administered of any glycoprotein IIb/IIIa inhibitor (including abciximab, eptifibatide, sibrafiban and tirofiban) in the 24 hours prior to screening.
- •Patient with subacute bacterial endocarditis and clinical pericarditis including pericarditis after this episode of acute myocardial Infarction.
- •Patient 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 patient, or any other circumstances that prevent the patient from participating in the study safely.
结局指标
主要结局
Rate of TIMI grade 3 flow (Thrombolysis In Myocardial Infarction) of the infarct related artery
时间窗: At 90 minutes
次要结局
- 50% resolution of elevated ST segment(At day 7, 14 and 30 or EOS if its earlier)
- All cause 30 day mortality rate(Day 30)
- Changes in left ventricular ejection fraction assessed by 2D-Echocardiography(At day 7, 14 and 30 or EOS if its earlier)
- Events of ventricular tachyarrhythmias(At day 7, 14 and 30 or EOS if its earlier)
- Pharmacokinetic parameters comparisons of Cmax, AUC0-t and AUC0-inf(After Single Dose Administration)
- Change in cardiac enzymes level(At hours 24 and 48)
- Immunogenicity assessment(At baseline and day 30 or EOS, if its earlier)
- Treatment emergent adverse events (clinical and laboratory)(Throughout the study period)
- Events of myocardial re-infarction(s)(At day 7, 14 and 30 or EOS if its earlier)
研究者
研究点 (21)
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