Effect of Enoxaparin on serum level of activated anti-factor XA in myocardial infarction patients with acute coronary syndrome: a before-after clinical trial
To assess the effect of Enoxaparin on serum level of activated anti-factor XA in myocardial infarction patients with acute coronary syndrome.
Design
A before-after clinical trial.
Settings and conduct
The eligible myocardial infarction patients with acute coronary syndrome who will refer to Farshchian Heart Hospital during the study period will be enrolled into the trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18 to 90 years; myocardial infarction with acute coronary syndrome.
Exclusion criteria: Low blood platelet; heparin induced thrombocytopenia; uncontrolled hypertension; bacterial endocarditis; hemorrhagic stroke; gastric or duodenal ulcer; severe renal insufficiency; diabetic retinopathy; coagulation disorders.
Intervention groups
Intervention group: Enoxaparin 1 mg/kg subcutaneously every 12 hours in people over 75 years of age or with renal creatinine clearance less than 30 ml/min. In people under 75 years of age or with renal creatinine clearance greater than 30 ml/min, in addition to the above dose, 30 mg of Enoxaparin is injected as a single intravenous dose.
Control group: In comparison with before intervention
Main outcome variables
Primary outcome: Assessing serum level of activated anti-factor XA before intervention and 12 hours after intervention through laboratory test.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N198
Registration date:2017-12-03, 1396/09/12
Registration timing:registered_while_recruiting
Last update:2017-12-03, 1396/09/12
Update count:0
Registration date
2017-12-03, 1396/09/12
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-27, 1395/07/06
Expected recruitment end date
2018-02-27, 1396/12/08
Actual recruitment start date
2016-09-27, 1395/07/06
Actual recruitment end date
2018-02-27, 1396/12/08
Trial completion date
empty
Scientific title
Effect of Enoxaparin on serum level of activated anti-factor XA in myocardial infarction patients with acute coronary syndrome: a before-after clinical trial
Public title
Effect of Enoxaparin on serum level of activated anti-factor XA in myocardial infarction patients with acute coronary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 90 years
myocardial infarction with acute coronary syndrome
This is a before after trial without randomization. Blinding is not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2016-06-25, 1395/04/05
Ethics committee reference number
IR.UMSHA.REC.1395.177
Health conditions studied
1
Description of health condition studied
Myocardial infarction with acute coronary syndrome
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Assessing serum level of activated anti-factor XA
Timepoint
Before intervention and 12 hours after intervention
Method of measurement
Through laboratory test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Enoxaparin 1 mg/kg subcutaneously every 12 hours in people over 75 years of age or with renal creatinine clearance less than 30 ml/min. In people under 75 years of age or with renal creatinine clearance greater than 30 ml/min, in addition to the above dose, 30 mg of Enoxaparin is injected as a single intravenous dose.
Category
Treatment - Drugs
2
Description
Control group: In comparison with before intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Heart Hospital
Full name of responsible person
Dr Jila Hashemi
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
cardio.jila@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
38380717
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jila Hashemi
Position
Resident of Cardiology
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
cardio.jila@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Shahram Homayoonfar
Position
Cardiologist
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
shahram1338@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available