Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001139965
Ethics application status
Approved
Date submitted
13/10/2011
Date registered
1/11/2011
Date last updated
1/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Difference between Heparin and Enoxaparin on inflammatory biomarkers in the treatment of heart attack (myocardial infarction).
Scientific title
Comparison between Heparin and Enoxaparin on inflammatory biomarkers (IL6, hs-CRP, MPO, SAA and ferritin) in STEMI.
Secondary ID [1] 273202 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
STEMI 278958 0
inflammatory cytokin 278959 0
Condition category
Condition code
Cardiovascular 279137 279137 0 0
Coronary heart disease
Inflammatory and Immune System 279138 279138 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm1: STEMI patients ,Intravenous bolus Heparin(60 IU/kg followed by 1000 IU per hour continuous infusion to achieve an aPTT of 50-75 seconds,48 hours)The minimum duration of heparin therapy after MI is generally 48 hours, but it may be longer, depending on the individual clinical scenario.
Arm 2: STEMI patients ,enoxaparin (1mg/kg sub cutaneous every 12 hr ,48 hours)The minimum duration of enoxaparintherapy after MI is generally 48 hours, but it may be longer, depending on the individual clinical scenario.
Intervention code [1] 269535 0
Treatment: Drugs
Comparator / control treatment
Arm1: STEMI patients ,Intravenous bolus Heparin(60 IU/kg followed by 1000 IU per hour continuous infusion to achieve an aPTT of 50-75 seconds,48 hours)
Control group
Active

Outcomes
Primary outcome [1] 279783 0
changes in inflammatory biomarkers (IL6, hs-CRP, MPO, SAA and ferritin) in plasma of STEMI pateints following anticuagolant therapy.
Timepoint [1] 279783 0
0,12,24,48 hours after starting administration of Heparin or Enoxaparin
Secondary outcome [1] 294422 0
Nil
Timepoint [1] 294422 0
Nil

Eligibility
Key inclusion criteria
age >18
patients with definite STEMI diagnosis
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1-history of AMI or CHF or AF
2-history of liver( LFT> 3ULN), kidney(Cr>2 or Cr > 25% increase in baseline),thyroid disease or malignancy
3-acute or chronic infection or autoimmune disease
4- treatment with heparin or enoxaparin before study
5-pregnancy or breastfeeding
6-treatment with anti-inflammatory drug during 3 mounths ago

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 3908 0
Iran, Islamic Republic Of
State/province [1] 3908 0

Funding & Sponsors
Funding source category [1] 270031 0
University
Name [1] 270031 0
Tehran university of medical science
Country [1] 270031 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Tehran university of medical science
Address
16 Azar AVE,Tehran university of medical science,faculty of pharmacy ,Tehran,Iran,1417614411
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 269005 0
None
Name [1] 269005 0
Address [1] 269005 0
Country [1] 269005 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271987 0
pharmaceutical Science Reasearch center
Ethics committee address [1] 271987 0
Ethics committee country [1] 271987 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 271987 0
Approval date [1] 271987 0
Ethics approval number [1] 271987 0
89-1

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33264 0
Address 33264 0
Country 33264 0
Phone 33264 0
Fax 33264 0
Email 33264 0
Contact person for public queries
Name 16511 0
Mojtahedzadeh,Mojtaba
Address 16511 0
16 Azar AVE,Tehran university of medical science ,faculty of pharmacy,Tehran,1417614411
Country 16511 0
Iran, Islamic Republic Of
Phone 16511 0
+98, 912,1056032
Fax 16511 0
+98,21,66954709
Email 16511 0
Mojtahed@sina.tums.ac.ir
Contact person for scientific queries
Name 7439 0
Mojtahedzadeh,Mojtaba
Address 7439 0
16 Azar AVE,Tehran university of medical science ,faculty of pharmacy,Tehran,1417614411
Country 7439 0
Iran, Islamic Republic Of
Phone 7439 0
+98, 912,1056032
Fax 7439 0
+98,21,66954709
Email 7439 0
Mojtahed@sina.tums.ac.ir

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.