A Phase IV, Post-marketing, Prospective, Multicentre, Single Arm Clinical Study to Evaluate the Safety, Efficacy and Immunogenicity of Hetero-Tenecteplase for Thrombolysis in Acute Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 19
- 主要终点
- Incidence, severity, outcome, duration, action taken, and causality of
研究概览
简要总结
This is a Post-marketing, Prospective, Multicentre, Single Arm Clinical Study to evaluate the safety, efficacy and immunogenicity of intravenous injection Tenecteplase (Hetero Biopharma Limited) in adult patients of 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 enrolled and administered Hetero-Tenecteplase. 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, 60 days and 90 days for efficacy and safety assessments, then there will be safety follow up at 6 months. The study is expected to be completed in approximately 12 - 18 months after dosing of the first patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male and female of 18 years or above
- •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 with Suspected Myocardial Infarction with Persistent ST Elevation and/or Recent Left Bundle Branch Block (LBBB) within 6 Hours after the Onset of Acute Myocardial Infarction (AMI) 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 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
- •Patients with history of cerebrovascular accident
- •History of intracranial tumor, arteriovenous malformation, cerebral aneurysm, intracranial or intra spinal surgery or trauma within the past 2 months
- •Uncontrolled hypertension (systolic BP LTN 180 mmHg or diastolic BP GRTN 110 mmHg).
- •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.
- •If the patient participated in any clinical trials or clinical usage involving Tenecteplase, Alteplase or other anti-thrombolytic drugs prior to one year of enrolment.
结局指标
主要结局
Incidence, severity, outcome, duration, action taken, and causality of
时间窗: 180 days
individual adverse events [Labelled/Unlabelled and Serious/Non-
时间窗: 180 days
Serious] reported during the study
时间窗: 180 days
次要结局
- Incidence, severity, outcome of Adverse Events of Special Interest(Internal bleeding, involving intracranial and retroperitoneal sites, or the)
- Thromboembolic episodes.(Proportion of patients with Clinically Evident Successful Thrombolysis (Defined as)
- Mortality rate(30 days, 60 days and 90 days and 180 days)
- Immunogenicity assessment at Baseline(30 days, 90 days or end of the study, if earlier)
研究者
Dr Shubhadeep Sinha MD
Hetero Labs Limited