| CTRI Number |
CTRI/2009/091/000976 [Registered on: 30/12/2009] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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A clinical trial to study the effects of drug, Prasugrel in patients with acute coronary syndrome. |
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Scientific Title of Study
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"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" |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DSCS/MSN/Prasugrel/0209 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Nitin M Rathod |
| Designation |
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| Affiliation |
|
| Address |
Cooper Hospital, Vile Parle (W),Mumbai, nitinmr@yahoo.in
Mumbai
MAHARASHTRA
400057
India |
| Phone |
|
| Fax |
|
| Email |
nitinmr64@yahoo.com |
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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 |
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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 |
|
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Source of Monetary or Material Support
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| M/s,MSN Laboratories Ltd. |
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Primary Sponsor
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| Name |
M/s. MSN Laboratories Ltd. |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| 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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Acute Coronary Syndrome, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clopidrgrel |
75 mg daily |
| Intervention |
Prasugrel |
10 mg daily |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| 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.
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| 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.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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An Open list of random numbers |
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Blinding/Masking
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Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
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| 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 |
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Secondary Outcome
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| 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  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 |
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Target Sample Size
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Total Sample Size="200"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/07/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
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Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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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. |