The aim of this study was to evaluate treatment effects in patients with acute coronary syndrome is clexan Anagzaparyn drug. After the diagnosis of acute coronary syndrome (including STEMI, Non stemI, Un stable angina patients, the researcher will be introduced. And explain the objectives of the study and a researcher after obtaining the informed consent of patients randomized to random block 4-way A and B are divided into two treatment groups. The groups will be treated. One group with clexan (foreign agent) and the second group Anagzaparyn (internal medicine) will be treated. Inclusion criteria: all patients with ACS (STEMI, NON STEMI, unstable angina) referring to Imam Hossein hospital. Exclusion criteria: the sensitivity of the Anagzaparyn; those who have active bleeding; thrombocytopenia; previously received heparin. Both drugs for 3 to 5 days at a dose of 60 mg subcutaneously injected. Major bleeding, minor bleeding, thrombocytopenia, PTT are study outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015090821979N2
Registration date:2015-10-22, 1394/07/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-22, 1394/07/30
Registrant information
Name
Mojtaba Nasiri
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 1850
Email address
nasirim@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrood University of Medical Sciences and Health Services
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Complication of enoxaparin(Alborz Daroo) compared with clexane(Aventis, Lupin) in patient whit Acute coronary syndrome
Public title
Complication of enoxaparin(Alborz Daroo) compared with clexane(Aventis, Lupin) in patient whit Acute coronary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients with ACS (STEMI, NON STEMI, unstable angina) shahroud referring to Imam Hossein hospital.
Exclusion criteria: the sensitivity of the lamina propria Anagza; those who have active bleeding; thrombocytopenia; previously received heparin.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
240
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
Shahroud University of Medical Sciences and Health Services
Street address
Shahroud University of Medical Sciences and Health Services, Hafte-Tir Square, Shahroud
City
Shahroud
Postal code
Approval date
2015-01-21, 1393/11/01
Ethics committee reference number
930/22
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome
ICD-10 code
I24.9
ICD-10 code description
Acute ischaemic heart disease, unspecified
Primary outcomes
1
Description
Major bleeding
Timepoint
Until discharge from hospital
Method of measurement
Observation
2
Description
Minor bleeding
Timepoint
Until discharge from hospital
Method of measurement
Sheet urinary analysis
3
Description
Thrombocytopenia
Timepoint
Until discharge from hospital
Method of measurement
Patient test page
4
Description
PTT
Timepoint
Until discharge from hospital
Method of measurement
Patient test page
Secondary outcomes
empty
Intervention groups
1
Description
control: Clexan for 3 to 5 days at a dose of 60 mg subcutaneously injected.
Category
Treatment - Drugs
2
Description
Intervention: enoxaparin for 3-5 days at a dose of 60mg / bd subcutaneously injected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahroud Imam Hussein Hospital
Full name of responsible person
Street address
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences and Health Services
Full name of responsible person
Dr. Mohamed Hussein Emamian
Street address
Shahroud University of Medical Sciences and Health Services, Hafte-Tir Square, Shahroud
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences and Health Services
Full name of responsible person
Hamid Reza Azarnia
Position
Medical student
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences and Health Services, Hafte-Tir Square, Shahroud
City
Shahroud
Postal code
Phone
+98 27 3239 0764
Fax
Email
hamidrezaazarnia@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Jafar Tahmasebi
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences and Health Services, Hafte-Tir Square, Shahroud
City
Shahroud
Postal code
Phone
+98 27 3239 4086
Fax
Email
Dr.Tahmasebi.j@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mojtaba Nasiri
Position
Student of Medicine
Other areas of specialty/work
Street address
shahroud University of Medical Sciences and Health Services,Hafte-Tir Square,Shahroud
City
Shahroud
Postal code
Phone
+98 27 3239 4086
Fax
Email
nasirim@shmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)