| 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
|
|
|
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
|
|
|
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
|
|
|
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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