FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2009/091/000976 [Registered on: 30/12/2009]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of drug, Prasugrel in patients with acute coronary syndrome. 
Scientific Title of Study   "A DOUBLE BLIND, RANDOMIZED, MULTICENTRIC, PHASE-III TRIAL TO COMPARE THE EFFICACY, TOLERABILITY, AND SAFETY OF TABLET PRASUGREL WITH TABLET CLOPIDOGREL IN THE TREATMENT OF PATIENTS WITH ACUTE CORONARY SYNDROME" 
Secondary IDs if Any  
Secondary ID  Identifier 
DSCS/MSN/Prasugrel/0209  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Nitin M Rathod 
Designation   
Affiliation   
Address  Cooper Hospital, Vile Parle (W),Mumbai, nitinmr@yahoo.in

Mumbai
MAHARASHTRA
400057
India 
Phone    
Fax    
Email  nitinmr64@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Nitin M Rathod 
Designation   
Affiliation   
Address  Cooper Hospital, Vile Parle (W),Mumbai, nitinmr@yahoo.in

Mumbai
MAHARASHTRA
400057
India 
Phone    
Fax    
Email  nitinmr64@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Nitin M Rathod 
Designation   
Affiliation   
Address  Cooper Hospital, Vile Parle (W),Mumbai, nitinmr@yahoo.in

Mumbai
MAHARASHTRA
400057
India 
Phone    
Fax    
Email  nitinmr64@yahoo.com  
 
Source of Monetary or Material Support  
M/s,MSN Laboratories Ltd. 
 
Primary Sponsor  
Name  M/s. MSN Laboratories Ltd. 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Rajiv R Oza  Clinic ,Bhavnagar,Rajivoza59@hotmail.com  ,-
Bhavnagar
GUJARAT 


Rajivoza59@hotmail.com 
Dr Nitin M Rathod  Cooper Hospital, Vileparle(W), Mumbai, nitinmr64@yahoo.com  ,-
Mumbai
MAHARASHTRA 


 
Dr. Kirti C Patel  K.E.M.Hospital & Seth G.S. Medical College,Mumbai,pkirtic@yahoo.in  ,-
Mumbai
MAHARASHTRA 


pkirtic@yahoo.in 
Dr. Raj G Bhagat  Smt. N H L Muni. Medical College,Ahmedabad,Rajpurvi@yahoo.com  ,-
Ahmadabad
GUJARAT 


Rajpurvi@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
COMSARTs  Approved 
COMSARTs  Approved 
COMSARTs  Approved 
COMSARTs  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
  Acute Coronary Syndrome 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clopidrgrel  75 mg daily 
Intervention  Prasugrel   10 mg daily 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  1. All patients with duly filled in ICFs [Informed Consent Forms] 2. Ages: Eligible For Study: 18-75Years, 3. Genders eligible for study: Both 4. The most important inclusion criteria for patients with unstable angina or non?ST-elevation myocardial infarction are:  Ischemic symptoms lasting 10 minutes or more and occurring within 72 hours before randomization,  A TIMI risk score of 3 or more, and  Either ST-segment deviation of 1 mm or more or  Elevated levels of a cardiac biomarker of necrosis. 5. Patients with ST-elevation myocardial infarction could be enrolled within 12 hours after the onset of symptoms if primary PCI is planned or within 14 days after receiving medical treatment for ST-elevation myocardial infarction.  
 
ExclusionCriteria 
Details  Patients unwilling to sign on ICF. Patients with known hypersensitivity to the study medications Patients with increased risk of bleeding, anemia, thrombocytopenia Patients having complaints of hemoptysis, epistaxis or hemetemesis Patients with a history of pathologic intracranial findings Patients with the use of any thienopyridine within 5 days before enrollment. Patients with significant renal impairment (Blood Urea Nitrogen, >35 mg/dL; Serum Creatinine, >2.5 mg/dL; Or Creatinine Clearance, <40 ml/min Per 1.73 m2 of body surface area), Patients with severe hepatic disease Pregnancy or breast-feeding Any other serious diseases having fatal progression.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary efficacy end point will be a composite of the rate of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke during the follow-up period. Additional prespecified analyses will include an analysis of the rates of the primary end point from randomization to day 3 and a landmark analysis of those data from day 3 to the end of the study.   day 3 to end of study 
 
Secondary Outcome  
Outcome  TimePoints 
Key secondary end points at 30 and 90 days will be the primary composite end point and a composite of death from cardiovascular causes, nonfatal myocardial infarction, or urgent target-vessel revascularization &#61607; Additional secondary end points for the entire follow-up period were stent thrombosis and a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or rehospitalization due to a cardiac ischemic event.   5 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   No Date Specified 
Date of First Enrollment (Global)  10/07/2009 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)   
Publication Details    
Brief Summary   This study is randomized,double blind,multicentr trial comparing the safety and efficacy of Tablet prasugrel with tablet Clopidogrel in the treatment of patients with acute coronary syndrome that will be conducted in four centres in India. 
Close