Health Condition 1: null- Patients with ST segment elevation Myocardial Infarction
Conditions
Interventions
Intervention1: R-TPR-012: Administered as per the body weight Intravenously as bolus, single dose
Control Intervention1: Metalyse(R): Administered as per the body weight Intravenously as bolus, single
Sponsors
Reliance Life sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects in the range of 18 to 65 years of age (inclusive). 2. Subjects presenting with chest pain and/or equivalent symptoms and diagnosis of Acute Myocardial Infarction confirmed by physician along with following ECG changes (12 lead). ï?· ST elevation of >= 0.1 mV in two or more limb leads or ï?· ST elevation of >= 0.2 mV in two or more contiguous precordial leads 3. Subjects presenting with AMI within 6 hours of occurrence of symptoms. 4. Women of child bearing potential having a negative pregnancy test and taking adequate birth control measures. 5. Consent from Legally Acceptable Representative (LAR), if subject is not in the condition to give consent. However, when the subject is stable and is able to give consent, consent would be obtained to confirm his/her willingness to continue in the study 6. Subjects must be able to adhere to the study visit schedule and other protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Subjects with Left Bundle Branch Block (LBBB). 2. History of contraindication to the use of thrombolytics. 3. Internal active bleeding or known history of hemorrhagic diathesis. 4. Any known history of haemorrhagic stroke or stroke of unknown origin 5. Any history of ischaemic stroke or transient ischaemic attack in the preceding 6 months 6. 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). 7. Unexplained puncture in a non-compressible vascular location in the last 24 hours prior to screening for study. 8. Confirmed arterial hypertension of systolic BP 200 mm Hg and diastolic BP 110 mm Hg at entry which does not respond rapidly to treatment. 9. Cardiogenic shock (Systolic BP 60 mm Hg) 10. Administration of Tenecteplase in the last 14 days prior to screening for study. 11. Administration of any glycoprotein IIa/IIIb inhibitor in the 24 hrs prior to screening for study. 12. Subjects on oral anticoagulant treatment. 13. Suspected AMI secondary to occlusion of one lesion treated previously with a per-cutaneous coronary intervention. 14. Suspicion of aortic dissection. 15. Subjects with subacute bacterial endocarditis and clinical pericarditis including pericarditis after this episode of acute myocardial Infarction. 16. Pregnant and lactating females. 17. Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis (based on history and examination) 18. Any other condition like active peptic ulceration, acute pancreatitis, which investigator feels would pose a significant hazard to subject if IP is administered 19. High risk subjects as per TIMI risk scoring. Such patients can be included after discussion with medical monitor, if investigator feels the study treatment as best possible option available for the subject. 20. Participation in any clinical study of an investigational product within the previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint will be rate of TIMI 3 flow (Thrombolysis In Myocardial Infarction) of the infarct related artery at 90 minutes and all-cause mortality rate at 30 days post dosing in subjects with STEMI following treatment with R-TPR-012/MetalyseTimepoint: 30 DAYS | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 50% resolution of elevated ST segment 2. Events of myocardial re-infarction(s) 3. Changes in left ventricular ejection fraction assessed by Echocardiography 4. Events of ventricular tachyarrhythmias 5. All-cause mortality rate at 6 months and 1 year post dosing considering the day of dosing as day 0 6. Change from baseline in cardiac enzymes level 7. Pharmacokinetic parameters assessment 8. Immunogenicity assessment 9. SafetyTimepoint: 30 days | — |
Countries
India
Contacts
Public ContactDr Jay Madkaikar
Reliance Life Sciences Pvt. Ltd
Outcome results
None listed