This randomized trial evaluated the effect of Loratadine on the rate of readmission and the incidence of recurrent angina in patients with acute coronary syndrome in 200 patients diagnosed with acute coronary syndrome (Bravnvald class 2 and 3) admitted in the CCU ward of Ali Ibn Abi Talib Hospital (AS), Rafsanjan. The patients in the control group received Aspirin plus Heparin plus a beta-blocker. In the intervention group, Loratadine (oral tablet 10 mg daily for a month) was added to the medication of the control group. The frequency of recurrent angina and readmission were measured on a weekly basis and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903131061N7
Registration date:2010-07-03, 1389/04/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-07-03, 1389/04/12
Registrant information
Name
Reza Vazirinejad
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 39 1822 0097
Email address
pejoheshi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-05-22, 1389/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Loratadine effect on the rate of rehospitalization and recurrent angina in patients with acute coronary syndrome
Public title
Loratadine effect on the rate of rehospitalization and recurrent angina in patients with acute coronary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: class 2 and 3 of Braunwald criteria
Exclusion criteria: prior history of hospitalization due to acute coronary syndrome, presence of liver disease, using antihistamines drugs such drugs as Cimetidine, Erythromycin, Clarithromycin, anti-fungal group and Fluoxetine
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics in medical research committee of Rafsanjan University of Medical Sciences
Street address
Central organization of Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan,
City
Rafsanjan
Postal code
Approval date
2009-03-19, 1387/12/29
Ethics committee reference number
9/20/2097
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
Readmission
Timepoint
Baseline, the first, second , third, and fourth week after the intervention
Method of measurement
Visual analog scale of readmission
2
Description
Recurrent angina
Timepoint
Baseline, the first, second , third, and fourth week after the intervention
Method of measurement
Descriptive scale of chest pain
Secondary outcomes
1
Description
Side effects of loratadine
Timepoint
Baseline, the first, second , third, and fourth week after the intervention
Method of measurement
Descriptive scale of symptoms such as headache, insomnia, weakness
Intervention groups
1
Description
Intervention group: Loratadine, oral tablet, 10 mg daily for a one month course + Aspirin, oral tablet 80 mg daily + Metoral, oral tablet 25-50 mg towise in day
Category
Treatment - Drugs
2
Description
Control group: Aspirint oral tablet 80 mg daily + Metoralt oral tablet 25-50 mg towice in day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Cardiology, Ali ibn Abi Talib (AS) hospital, Rafsanjan University of Medical Sciences
Full name of responsible person
Street address
City
Rafsanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Hossein Azin
Street address
Rafsanjan University of Medical Sciences, Emam ali Blvd.
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Ali Esmaeeli Nadimi
Position
Board of Cardiology
Other areas of specialty/work
Street address
Ali ibn Abi Talib (AS) hospital, department of cardiology
City
Rfsanjan
Postal code
00989131913649
Phone
+98 39 1822 0001
Fax
Email
dr_nadimi@yahoo.co.uk
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Monavar Naderi
Position
BS/labrarin
Other areas of specialty/work
Street address
Rafsanjan University of Medical Sciences, Emam ali Blvd.
City
Rafsanjan
Postal code
7717933777
Phone
+98 39 1822 0086
Fax
+98 39 1822 0086
Email
monanaderi56@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)