A comparative study between hemodynamic effect of metoprolol tartrate and metoprolol succinate in Acute Coronary Syndrome patients who admitted in Imam Ali hospital in Kermanshah city, 2015
The goal of this study is comparison between hemodynamic effect of metoprolol tartrate and metoprolol succinate in patients who admitted with ACS in Imam Ali hospital in Kermanshah city, Iran in 2015 and will be performed as double blind study.
At least 100 patients are selected and divided in two groups, randomly. The first one take metoprolol tartrate 25-50mg, twice daily or QID and the last take metoprolol succinate 23.75 or 47.5mg once or twice daily and evaluate for blood pressure and heart rate in 72 hours. Several items like age, sex, smoking, and history of blood pressure is also contemplated.
Inclusion criteria: age older than18 years old with Acute Coronary Syndrome diagnosis.
Exclusion criteria: age less than 18 years old; severe pulmonary disease and severe asthma; use of other beta blockers; use of calcium channel blocker, digoxin; II and III degree heart block; peripheral vascular disease and Diabetes Melitus.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016010425839N1
Registration date:2016-02-02, 1394/11/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-02, 1394/11/13
Registrant information
Name
Reza Heidarymoghadam
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3836 0041
Email address
heidary@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study between hemodynamic effect of metoprolol tartrate and metoprolol succinate in Acute Coronary Syndrome patients who admitted in Imam Ali hospital in Kermanshah city, 2015
Public title
A comparative study between metoprolol tartrate and metoprolol succinate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age older than18 years old with Acute Coronary Syndrome diagnosis.
Exclusion criteria: age less than 18 years old; severe pulmonary disease and severe asthma; use of other beta blockers; use of calcium channel blocker, digoxin; II and III degree heart block; peripheral vascular disease and Diabetes Melitus.
Age
From 18 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
56
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
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2015-11-24, 1394/09/03
Ethics committee reference number
IR.KUMS.REC.1394.218
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
Primary outcomes
1
Description
Blood pressure
Timepoint
At admission until 72 hours
Method of measurement
mm Hg by mercuric manometer
2
Description
Heart rate
Timepoint
At admission until 72 hours
Method of measurement
By physician
Secondary outcomes
empty
Intervention groups
1
Description
Metoprolol tartrate, tablet 25-50mg, BID or QID.
Category
Treatment - Drugs
2
Description
Metoprolol succinate 23.75 or 47.5 mg OD or BID
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali hospital
Full name of responsible person
Dr. Maziar Rezvani Gil Kolaee
Street address
Imam Ali hospital, Shahid Beheshti blv
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Kourosh Hamzeii
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
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
Kermanshah University of Medical Sciences, Imam Ali Hospital
Full name of responsible person
Dr. Maziar Rezvani Gil Kolaee
Position
MD, Resident of Cardiology
Other areas of specialty/work
Street address
Imam Ali Hospital, Shahid Beheshti Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3837 0252
Fax
Email
maziar718@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Heidary Moghadam
Position
Fellowship of Interventional Cardiology
Other areas of specialty/work
Street address
Imam Ali Hospital, Shahid Beheshti Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3837 0252
Fax
Email
heidarymoghadam@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Maziar Rezvani Gil Kolaee
Position
MD, Resident of Cardiology
Other areas of specialty/work
Street address
Imam Ali Hospital, Shahid Beheshti Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3837 0252
Fax
Email
maziar718@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)