This study was designed to determine whether Enoxaparin was associated with superior efficacy and safety comparing with unfractionated heparin (UFH) in the myocardial infarction with ST-segment elevation (STEMI) setting. Patients aged 18 to 75 years old, with onset of symptoms of acute myocardial infarction within 12 hrs prior to randomization, and ST-segment elevation of 0.1 mV or more in two or more limb leads or at least 0.2 mV in two or more precordial leads were enrolled in this study. Cases with any contraindication to receive streptokinase, cardiogenic shock, receiving glycoprotein IIb/IIIa antagonists or oral anticoagulants within prior days or therapeutic dose of heparin or low molecular-weight heparin within the previous hours, need for anticoagulant therapy and also any other disease that resulted in increasing the risk were excluded. 150 patients with ST-elevation myocardial infarction who were scheduled to receive streptokinase (1.5 million unit infusion per hour) randomly assigned to receive Enoxaparin (40 mg intravenous bolus then 1 mg/kg subcutaneously BID for at least 5 days) or unfractionated heparin (UFH) [according to Ratke ] 24 to 48 hours after streptokinase for at least 5 days. A coronary angiography was done for the patients before discharge. Two groups were compared in terms of thombolysis in myocardial infarction (TIMI), grade III flow (patency) on angiography, ST-segment resolution at 90 min on ECG; and estimation of ejection fraction using angiography.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711271695N1
Registration date:2009-04-25, 1388/02/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-04-25, 1388/02/05
Registrant information
Name
Majid Asadi
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
98+ 771 2524044
Email address
asadi@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2006-06-22, 1385/04/01
Expected recruitment end date
2008-03-18, 1386/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and usefulness of Enoxaparin versus unfractionated heparin in patients with ST elevation myocardial infarction
Public title
Safety and usefulness of Enoxaparin versus unfractionated heparin in patients with ST elevation myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Age range 18 to 75 years old, onset of symptoms of acute myocardial infarction within 12 hrs before randomization, ST-segment elevation of 0.1 mV or more in two or more limbs leads or at least 0.2 mV in two or more precordial leads.
Exclusion Criteria: Contraindications to streptokinase, cardiogenic shock, receiving glycoprotein IIb/IIIa antagonists or oral anticoagulants within the prior days or therapeutic dose of heparin or low molecular-weight heparin within the previous hours, need for anticoagulant therapy and also any other disease that resulted in increasing risk
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences and Health Services
Street address
Faculty of Medicine, Poursina St.
City
Tehran
Postal code
Approval date
2006-06-18, 1385/03/28
Ethics committee reference number
237
Health conditions studied
1
Description of health condition studied
Ischaemic heart diseases
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
ST-segment resolution
Timepoint
90 minutes after intervention
Method of measurement
ECG
2
Description
Ejection Fraction
Timepoint
during 5-10th day of admission
Method of measurement
Angiography
3
Description
Thombolysis in Myocardial Infarction (TIMI) flow grade 3 (patency)
Timepoint
during 5-10th day of admission
Method of measurement
Through angiography
Secondary outcomes
empty
Intervention groups
1
Description
Streptokinase (1.5 million units intravenously over 1 h) plus unfractionated heparin for a minimum of 48 hours and adjusted to the activated partial thromboplastin time according to the American Heart Association/American College of Cardiology guidelines, including the duration of therapy. Treatment was continued for a minimum of 4 days, up to 10th day or when angiography was to be done, whichever was earlier
Category
Treatment - Drugs
2
Description
Streptokinase (1.5 million units intravenously over 1 h) plus Enoxaparin was administered as an intravenous bolus (40 mg) and then subcutaneously every 12 hrs (1 mg/kg) with a maximum of 100 mg for the first two subcutaneous injections
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Mohammad Reza Pourbehi
Street address
Tehran, North Kargar St
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr Mohammad Reza Pourbehi
Street address
Faculty of Medicine, Poursina St.
City
Tehran
Grant name
237
Grant code / Reference number
237
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences and Health Services
Full name of responsible person
Mohammad Reza Pourbehi
Position
Cardiologist
Other areas of specialty/work
Street address
Bushehr , Moallem St. Faculty of Medicine
City
Bushehr
Postal code
3631
Phone
+98 77 1252 4044
Fax
Email
m_purbehi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences and Health Services
Full name of responsible person
Mohammad Reza Pourbehi
Position
Cardiologist
Other areas of specialty/work
Street address
Bushehr , Moallem St. Faculty of Medicine
City
Bushehr
Postal code
3631
Phone
+98 77 1252 4044
Fax
+98 77 1252 4044
Email
m_pourbehi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bushehr University of Medical Sciences and Health Services
Full name of responsible person
Mohammad Reza Pourbehi
Position
Cardiologist
Other areas of specialty/work
Street address
Bushehr , Moallem St. Faculty of Medicine
City
Bushehr
Postal code
3631
Phone
+98 77 1252 4044
Fax
+98 77 1252 4044
Email
m_pourbehi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)