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CTRI Number  CTRI/2011/08/001950 [Registered on: 16/08/2011] Trial Registered Prospectively
Last Modified On: 28/02/2013
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   prospective study 
Study Design  Other 
Public Title of Study   An observational multicenter study comparing Tenecteplase assisted Percutaneous Coronary Intervention (PCI) versus primary PCI in Indian patients with ST elevation Myocardial Infarction 
Scientific Title of Study   A prospective, observational, multicenter study comparing Tenecteplase facilitated PCI versus primary PCI in Indian patients with STEMI  
Trial Acronym  STEPPAMI 
Secondary IDs if Any  
Secondary ID  Identifier 
LA-RSH/93/2011  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mullasari Ajit sankardas 
Designation  Director-Cardiology 
Affiliation  Medical mission hospital 
Address  Institution of cardio vascular diseases,Madras Medical mission hospital,4A,Dr.J.Jayalalithanagar,Mogappair,Chennai

Chennai
TAMIL NADU
600 037
India 
Phone    
Fax    
Email  icvddoctors@mmm.org.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Thomas Alexandar 
Designation  consultant & Interventional cardiologist 
Affiliation  Kovai Medical Center and Hospital  
Address  Kovai Medical Center and Hospital P.B.No.:3209,Avinashi road Coimbatore,

Coimbatore
TAMIL NADU
641014
India 
Phone    
Fax    
Email  tomalex41@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mullasari Ajit sankardas 
Designation   
Affiliation   
Address  Institution of cardio vascular diseases,Madras Medical mission hospital,4A,Dr.J.Jayalalithanagar,Mogappair,Chennai


TAMIL NADU
600 037
India 
Phone    
Fax    
Email  icvddoctors@mmm.org.in  
 
Source of Monetary or Material Support  
STEMI India Charitable trust,SiteNo.204-205, Gold wings, Poongothai Nagar,Coimbatore-640014 
 
Primary Sponsor  
Name  STEMI India Charitable Trust 
Address  STEMI India Charitable Trust Siteno. 204-205,gold wings,Poongothai nagar,Coimbatore-640014 
Type of Sponsor  Other [Investigator initiated study] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bahuleyan  Ananthapuri Hospitals  Department of Cardiology,Chacka, NH Bypass, Trivandrum, Kerala - 695 024.
Thiruvananthapuram
KERALA 
91-9447344882

bahuleyan2001@yahoo.co.uk 
Dr Sunil Chandy  Christian Medical college  Department of Cardiology,Thorapadi Post, Bagayam, Vellore - 632002, Tamilnadu, India
Vellore
TAMIL NADU 
91-9443350389

schandy@cmcvellore.ac.in 
Dr Thomas Alexander   Kovai Medical Center  Department of Cardiology, Avinashi Road coimbatore- 641014
Coimbatore
TAMIL NADU 
9791907685

tomalex41@gmail.com 
Dr Ajit Mullasari  Madras Medical Mission Hospitals  Deapartment of cardiology, No.4-A, Dr.Jayalalita Nagar, Moggapair, Chennai-600037, Tamilnadu, India
Chennai
TAMIL NADU 
044-26561801

icvddoctors@mmm.org.in 
Dr Selvamani  Meenakshi Mission Hospital and Research Centre  Department of Cardiology,Lake Area, Melur Road, Madurai, Tamil Nadu, India - 625 107, Madurai
Madurai
TAMIL NADU 
91-9842158868

maniselva@hotmail.com 
Dr Mark Christopher  Pondicherry Institute of Medical Sciences  Department of Cardiology,Kalathumettupathai,Ganapathichettikulam, Village No.20, Kalapet, Puducherry - 605 014, INDIA
Pondicherry
PONDICHERRY 
91-9751783843

markchristopher3@yahoo.co.in 
Dr Arun Srinivas  Vikram Group of Hospitals  Department of Cardiology,no.46, Vivekananda Road, Yadavagiri, Mysore-570020
Mysore
KARNATAKA 
91-9845028387

arunsrinivas@vhpl.com 
Dr Subhash Chandra  Vikram Group of Hospitals  Department of Cardiology, No.71/1, Opp To ST. Annes College, Millers Road, Bangalore - 560052
Bangalore
KARNATAKA 
91-9845024263

sindhu06v@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
ethical review board/Madurai/Dr. S. Selvamani  Approved 
Ethics committee/Thiruvananthapuram/Dr. C. G. Bahuleyan  Approved 
Independent Ethics Committee/Bangalore/Dr. Arun Srinivas  Approved 
Independent Ethics Committee/Bangalore/Dr. Subhash Chandra  Approved 
Institution Ethics commitee/Chennai/Dr. Mullasari S. Ajit  Approved 
Institutional Ehics commitee/Pondicherry/Dr. Mark Christopher  Not Applicable 
Institutional Review Board/Vellore/Dr. Sunil chandy  Not Applicable 
KMCH ethics commitee/Coimbatore/Dr. Thomas Alexander  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  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.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
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:

1)Nonintracranial hemorrhage (total, major, minor and blood transfusions)
2)Intracranial hemorrhage
 
Nil 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  
02/09/2011 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   No publication till date 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

 

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 revascularization as compared to thrombolytic therapy.  There is no primary data on Primary Percutaneous Coronary Intervention Vs TNK facilitated Percutaneous Coronary Intervention. In Indian 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 Name: 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 support. on 02-10-2011 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 02-10-2011

 

 
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