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1 Clinical Trial Details (PDF Generation Date :- Fri, 28 Dec :48:30 GMT) CTRI Number Last Modified On 28/02/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/08/ [Registered on: 16/08/2011] - Trial Registered Prospectively No Observational prospective study Other An observational multicenter study comparing Tenecteplase assisted Percutaneous Coronary Intervention (PCI) versus primary PCI in n patients with ST elevation Myocardial Infarction A prospective, observational, multicenter study comparing Tenecteplase facilitated PCI versus primary PCI in n patients with STEMI Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) LA-RSH/93/2011 Designation Affiliation Phone Fax Designation Affiliation Phone Fax Designation Affiliation Protocol Number Details of Principal Investigator Mullasari Ajit sankardas Director-Cardiology Medical mission hospital Institution of cardio vascular diseases,madras Medical mission hospital,4a,dr.j.jayalalithanagar,mogappair,chennai Chennai icvddoctors@mmm.org.in Details Contact Person (Scientific Query) Dr Thomas Alexandar consultant & Interventional cardiologist Kovai Medical Center and Hospital Kovai Medical Center and Hospital P.B.No.:3209,Avinashi road Coimbatore, Coimbatore tomalex41@gmail.com Details Contact Person (Public Query) Mullasari Ajit sankardas Institution of cardio vascular diseases,madras Medical mission hospital,4a,dr.j.jayalalithanagar,mogappair,chennai page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax Source of Monetary or Material Support > STEMI Charitable trust,siteno , Gold wings, Poongothai Nagar,Coimbatore Type of Sponsor NIL List of Countries of Principal Investigator Primary Sponsor Details STEMI Charitable Trust STEMI Charitable Trust Siteno ,gold wings,poongothai nagar,coimbatore Other [Investigator initiated study] NIL of Site Site Phone/Fax/ Dr Bahuleyan Ananthapuri Hospitals Cardiology,Chacka, NH Bypass, Trivandrum, Kerala Thiruvananthapuram KERALA Dr Sunil Chandy Christian Medical college Cardiology,Thorapadi Post, Bagayam, Vellore , Tamilnadu, Vellore Dr Thomas Alexander Kovai Medical Center Cardiology, Avinashi Road coimbatore Coimbatore Dr Ajit Mullasari Dr Selvamani Dr Mark Christopher Madras Medical Mission Hospitals Meenakshi Mission Hospital and Research Centre Pondicherry Institute of Medical Sciences Deapartment of cardiology, No.4-A, Dr.Jayalalita Nagar, Moggapair, Chennai , Tamilnadu, Chennai Cardiology,Lake Area, Melur Road, Madurai, Tamil Nadu, , Madurai Madurai Cardiolo gy,kalathumettupathai, Ganapathichettikulam, bahuleyan2001@yahoo.co.uk schandy@cmcvellore.a c.in tomalex41@gmail.com icvddoctors@mmm.org. in maniselva@hotmail.co m markchristopher3@yah page 2 / 7

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Dr Arun Srinivas Dr Subhash Chandra Vikram Group of Hospitals Vikram Group of Hospitals Village No.20, Kalapet, Puducherry , INDIA Pondicherry PONDICHERRY Cardiology,no.46, Vivekananda Road, Yadavagiri, Mysore Mysore KARNATAKA Cardiology, No.71/1, Opp To ST. Annes College, Millers Road, Bangalore Bangalore KARNATAKA oo.co.in arunsrinivas@vhpl.com sindhu06v@yahoo.co.in of Committee Approval Status Date of Approval Is Independent Ethics Committee? ethical review board/madurai/dr. S. Selvamani Approved 29/09/2011 No Ethics committee/thiruv Approved 31/08/2011 No ananthapuram/dr. C. G. Bahuleyan Independent Ethics Co mmittee/bangalore/dr. Arun Srinivas Independent Ethics Co mmittee/bangalore/dr. Subhash Chandra Institution Ethics commitee/chennai/dr. Mullasari S. Ajit Institutional Ehics com mitee/pondicherry/dr. Mark Christopher Institutional Review Board/Vellore/Dr. Sunil chandy KMCH ethics commitee /Coimbatore/Dr. Thomas Alexander Status Health Type Approved 15/09/2011 Yes Approved 09/09/2011 Yes Approved 06/09/2011 No No Date Specified No No Date Specified No Approved 10/08/2011 No Date No Date Specified Condition Patients Patients with acute STEMI who are to be treated with primary PCI/pharmacoinvasive therapy within 12 hours of symptoms onset will be included. Type Details Inclusion Criteria page 3 / 7

4 Age From Age To Gender Details Year(s) Year(s) Both All patients included in the study should satisfy the following criteria. 1.Adults 18 to 75 years of age complaining of chest pain, discomfort and/or indications of STEMI requiring either primary PCI or tenecteplase facilitated PCI will be included in the study. 2.Patients presenting with the onset of symptoms within 12 hours. 3.ECG including right ventricular leads (V4R) indicative of an acute STEMI (ST elevation will be measured from the J point scale; 1 mm per 0.1 mv greater than or equal to 2 mm ST elevation across 2 contiguous precordial leads (V1-V6) or leads I and avl for a minimum combined total of greater than or equal to 4 mm ST elevation) OR Greater than or equal to 3mm ST elevation in 2 contiguous inferior leads (II, III, avf) for a minimum combined total of greater than or equal to 6 mm ST elevation. 4.Subjects / LAR or impartial witness (if applicable) must be able to understand and provide their consent in the informed consent form. Exclusion Criteria Details Exclusion Criteria Patients meeting any of the following criteria will not be enrolled into the study. 1.Previous enrollment in this study or treatment with the investigational drug or participating in any other study in the past 30 days 2.Patients who are unwilling to participate in the study or sign the informed consent Method of Generating Random Sequence Method of Concealment Blinding/Masking Primary Outcome Outcome Timepoints Following are the Primary Endpoints: Death and reinfarction Death maybe due to cardio vascular and non-cardio vascular reasons. Death due to cardio vascular reasons may include: 1)Reinfarction 2)Cardiogenic Shock 3)Cardiac failure Death due to non cardio vascular reasons may include 1)Procedure related injury 2)Others Nil Secondary Outcome Outcome Timepoints Following are the Secondary Endpoints: Nil 1)Nonintracranial hemorrhage (total, major, page 4 / 7

5 minor and blood transfusions) 2)Intracranial hemorrhage Target Sample Size Phase of Trial Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=200 Sample Size from =200 N/A 02/09/2011 No Date Specified Years=1 Months=6 Days=0 Completed No publication till date This is a study comparing 2 treatment options that are available and practiced for the treatment for STEMI. There will be no treatment assigned for the study and no intervention done for the study. Data will be collected on an observational basis from patients who undergo primary PCI and from patients who receive facilitated PCI for the same condition. Primary objective: The primary objective of this study is to assess the efficacy of prompt fibrinolysis coupled with contemporary antiplatelet and antithrombotic therapy at first medical contact followed by timely catheterization or rescue coronary intervention in STEMI patients within 12 hours of symptom onset versus a strategy of Standard Primary Percutaneous Coronary I Study hypothesis: Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction is a preferred mode of page 5 / 7

6 revascularization as compared to thrombolytic therapy. There is no primary data on Primary Percutaneous Coronary Intervention Vs TNK facilitated Percutaneous Coronary Intervention. In n context TNK facilitated PCI (Pharmacoinvasive therapy) is a more practical solution. This study aims to confirm the efficacy and safety of Primary PCI Vs Pharmacoinvasive therapy in 200 patients across 8 centers. Serious Adverse Events: Centre : Kovai medical Centre,Coimbatore Principal Investigator: Dr.Thomas Alexender SAE reported : Cardiogenic shock SAE reported on : 02 -Oct-2011 SAE out come : Death Causal relation with treatment : not applicable SAE narrative: 60 years old patient was admitted with compliance of chest pain,breathlessness on 29-O9-2011, ECG was performed and the result showed ST elevation. Patient was considered for the study and hence screened. Preangioplasty angiogram revealed total occlution of the LAD proxiamlly which was Stented with drug eluting stent.during the procedure patient had bradycardia and bundle branch block for which the patient was put on temporary pacing and Ionotropic support.patient was intubated and ventilatedfor persistent and worsening hypoxemia.patient was having persistant hypotension and requring multiple inotropic page 6 / 7

7 Powered by TCPDF ( PDF of Trial support. on at 9:15 am patient had asystolic cardiac arrest.cpr started as per the ACLS protocol.inspite of all resuscitative efforts patient could not be revieved and declared death at 09:27 am on page 7 / 7