A Phase IV, Post-marketing, Prospective, Multicentre, Single Arm Clinical Study toEvaluate the Safety, Efficacy and Immunogenicity of Hetero-Tenecteplase forThrombolysis in Acute Myocardial Infarction - NI

Hetero Biopharma Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

暂无简介。

•1. Adult male and female of 18 years or above
•2. 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
•3. 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
•4. Women of childbearing potential must agree to get pregnancy test done
•at the time of enrolment and it should be negative.

•1. Patients contraindicated or with history/evidence of hypersensitivity to
•thrombolytics or any of the components of formulation.
•2. Patients with history/ active internal active bleeding or hemorrhagic
•3. Patients with history of cerebrovascular accident
•4. History of intracranial tumor, arteriovenous malformation, cerebral aneurysm, intracranial or intra spinal surgery or trauma within the past 2
•5. Uncontrolled hypertension (systolic BP LTN 180 mmHg or diastolic BP GRTN 110 mmHg).
•6. 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.
•7. 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.

发起方