Health Condition 1: null- Acute ST-segment Elevation Myocardial Infarction
Conditions
Interventions
Intervention1: SMRX-11, is a novel recombinant â??clot-busterâ?? thrombolytic drug: SMRX-11, is a novel recombinant â??clot-busterâ?? thrombolytic drug (CSSK). It is is a recombinant protein made by p
Sponsors
Symmetrix Biotech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient with acute ST Segment Elevation Myocardial Infarction (STEMI). ST segment elevation of at least 2 mm in 2 or more contiguous leads without LBBB, stroke or LVH (left ventricular hypertrophy). 2. Patients aged more than 18 and less 65 years old. 3. Patient has persistent ischemic chest pain lasting for more than equal to 30 minutes. 4. Patient has symptom duration less than 6 hours 5. Patient has no contraindications to thrombolytic therapy 6. Patients willing to adhere to the protocol requirements and to provide written informed consent.
Exclusion criteria
Exclusion criteria: a. Related to study methodology General 1. Has a history of hypersensitivity or allergies to similar class of drug as the study drug. 2. Has high probability of being unavailable for 30 day/1 year follow-up 3. Has age 18 years or 65 years 4. Female patients having pregnancy (positive urine pregnancy test) or, parturition within the previous 30 days, or with childbearing potential not using adequate contraception. 5. Female patients currently breast feeding. 6. Patient is an investigator, co-investigator, research staff or a relative thereof involved in the conduct of the trial. 7. Use of other investigational agents or devices within 30 days prior to enrollment in the study. 8. Inability to undergo cardiac catheterization. 9. History or presence of current cocaine abuse. 10. History or presence of active cancer or active infection. 11. Difficulty with donating blood. 12. Major illness during 3 months before screening. 13. Participation in a drug research study within past 3 months. 14. Donation of blood in the past 3 months before screening. 15. Symmetrix or company employees or investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted. Cardiovascular 1. Patient treated with any thrombolytic agent within the preceding month (with conventional streptokinase or APSAC within preceeding 12 months) for Acute Myocardial Infarction or any other thrombosis-related indication. 2. Previous history of Coronary Artery Bypass Grafting surgery (CABG) / previous Percutaneous Coronary Intervention (PCI). 3. Cardiogenic shock (eg. BP less than 90 mmHg with IV vasopressors or less than 80 mmHg without IV vasopressors). 4. History or presence of atrial fibrillation or atrial flutter. 5. LBBB new or old (difficulty in diagnosing STEMI and assessing ST resolution). 6. LVH (Left Ventricular Hypertrophy) by voltage criteria. b. Related to prior or concomitant treatments 1. Current use of oral anticoagulants (e.g. Coumadin), parental anticoagulants (.g. unfractionated or low molecular weight heparins) and thrombolytic agents. 2. Previous use of streptokinase within 12 months. 3. Use of GPIIb/IIIa inhibitors or P2Y12 inhibitors within 1 week of enrollment into the study. 4. Patient having a known allergy to aspirin. c. Related to current knowledge about conventional Streptokinase and SMRX-11 1. History of prior intracranial hemorrhage. 2. History or presence known structural cerebral vascular lesion (e.g., AVM- Arterio-venous malformation). 3. Patient has known malignant intracranial neoplasm (primary or metastatic). 4. Has suspected aortic dissection. 5. History or presence of active bleeding or bleeding diathesis (excluding menses). 6. Significant closed head trauma or facial trauma within 3 months. 7. History or presence of chronic, severe, poorly controlled hypertension. 8. Patients with severe and uncontrolled hypertension on presentation (SBP more than 180 mm Hg or DBP more than 110mmHg). 9. History of prior ischemic stroke more than 3 months, dementia, or known intracranial pathol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Efficacy of SMRX-11 in in Patients with Acute ST-segment Elevation Myocardial Infarction patientTimepoint: ACoronary Arteriography for TIMI flow will be performed at 90 minutes post administration of SMRX-11 at each dose level. And safety assessment at various time-points. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic and Safety of SMRX-11Timepoint: A total of 12 blood samples for pharmacokinetic determinations will be collected per patient. Post-dose blood samples of 2.7 mL each will be collected at 1 min, 3 min, 10 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr and 24 hr following end of drug administration. | — |
Countries
India
Contacts
Public ContactDr Sunil Karna
Shree Krishna Hospital
Outcome results
None listed