Efficacy of short term prescription of nicorandil on in-hospital outcomes of patients who admitted because of acute coronary syndrome without ST elevation
In order to consider the efficacy of Nicoranil addition to common treatments, 252 patients are chosen among the patients suffering from acute coronary syndrome without ST elevation, who are admitted in Heart Center. Firstly, all of them are put in heart monitoring for 48 hours. Then, they are divided in two groups randomly. One group is treated by the common treatments like anti-thrombotic, anti-platelet and painkiller. Another group is put in Nicoranil in addition to these treatments. In the patients’ primary ECG, Myocardial Infarction with ST elevation or Left Bundle Branch Block should not be seen. These patients are visited during hospitalization daily by researcher. Both researcher and patients are not aware of prescription. There are the response criteria to treatment, which are recorded, including the number of chest pain episode, arrhythmia, the echocardiography characters, the amount of increasing in myocardial enzymes as well as the number of hospitalization days. The results are recorded in special forms and considered by a statistics expert.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202189067N1
Registration date:2012-03-01, 1390/12/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-01, 1390/12/11
Registrant information
Name
Sara Jadbabaei
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 83 1836 2022
Email address
jadbabaei@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences, Vice-chancellor for Research and technology
Expected recruitment start date
2012-02-04, 1390/11/15
Expected recruitment end date
2012-05-04, 1391/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of short term prescription of nicorandil on in-hospital outcomes of patients who admitted because of acute coronary syndrome without ST elevation
Public title
Efficacy of nicorandil in acute coronary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion:Non ST elevation acute coronary syndrome.
Exclusion criteria: myocardial infarction with ST levation and Left Bundle Branch Block
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
252
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
Kermanshah university of medical sciences and health services
Street address
Shahid Beheshti Blvd
City
Kermanshah
Postal code
671673159
Approval date
2012-01-31, 1390/11/11
Ethics committee reference number
پ/7/420/61202
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome
ICD-10 code
120_125
ICD-10 code description
Ischaemic heart disease
Primary outcomes
1
Description
Response treatment
Timepoint
During hospitalization daily
Method of measurement
Physician visit
Secondary outcomes
1
Description
Clinical side effect
Timepoint
During hospitalization daily
Method of measurement
Physician visit
Intervention groups
1
Description
Interventional group: Oral Nicorandil is started at first day of admission 20 mg BID in addition to common treatment,then continued during hospitalization until last day.
Category
Treatment - Drugs
2
Description
Control group:identical to that of common treatment including antithrombotic,antiplatelet and analgesics.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali hospital
Full name of responsible person
Sara Jadbabaei
Street address
Imam Ali hospital, Shahid Beheshti Blvd
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Siences and Health Services
Full name of responsible person
Dr. Farid Najafi
Street address
Shahid Beheshti Blvd, Kermanshah University of Medical Siences and Health Services
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 Siences 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
Kermanshah university of medical sciences and health services
Full name of responsible person
Sara Jadbabaei
Position
Cardiology resident
Other areas of specialty/work
Street address
Imam Ali hospital, Shahid Beheshti Blvd
City
Kermanshah
Postal code
Phone
+98 83 1836 2022
Fax
+98 83 1836 2022
Email
sara.jadbabaei@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Siences and Health Services
Full name of responsible person
Alireza Rai
Position
Interventional cardiologist
Other areas of specialty/work
Street address
Imam Ali hospital, Shahid Beheshti Blvd
City
Kermanshah
Postal code
Phone
+98 83 1836 2022
Fax
+98 83 1836 2022
Email
Alireza_rai@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Siences and Health Services
Full name of responsible person
Sara Jadbabaei
Position
Cardiology resident
Other areas of specialty/work
Street address
Imam Ali hospital, Shahid Beheshti Blvd
City
Kermanshah
Postal code
Phone
+98 83 1836 2022
Fax
+98 83 1836 2022
Email
sara.jadbabaei@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)