Evaluation of the effect of Ranolazine added to standard treatment to control angina pectoris in patients with coronary artery bridge who underwent angiography in Alzahra Heart Hospital, Shiraz during 2023 and 2024
Location: Alzahra heart hospital, Shiraz
Setting: After registration In the study, patients will be randomly divided into two groups. A group of participants will be given beta blocker for 6 months and for the other group of participants beta blocker and Ranolazine 500 mg (twice daily) will be given. After six months, patients in both groups will be re-evaluated and checked for symptomatic and functional process and the results will be compared.
All investigators, patients, and follow-up team members were unaware of the treatment allocation, making the study unbiased and controlled.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over18 years old; no renal/liver failure; willing to participate; dyspnea or angina at rest or on exertion; no coronary artery disease. Exclusion criteria: long QT interval; using CYP3A inhibitors; using medication that prolong the QT interval; pregnancy/lactation; Parkinson's disease; life expectancy less than 6 months.
Intervention groups
Control group (26 people): beta blocker will be given.
Intervention group (26 people): beta blocker and Ranolazine 500 mg (orally twice daily) will be given.
Main outcome variables
Severity of angina pectoris
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230801059005N2
Registration date:2023-11-08, 1402/08/17
Registration timing:registered_while_recruiting
Last update:2023-11-08, 1402/08/17
Update count:0
Registration date
2023-11-08, 1402/08/17
Registrant information
Name
Aida Bazrgar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 4196
Email address
aidabazrgar@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-08, 1402/08/17
Expected recruitment end date
2024-05-06, 1403/02/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Ranolazine added to standard treatment to control angina pectoris in patients with coronary artery bridge who underwent angiography in Alzahra Heart Hospital, Shiraz during 2023 and 2024
Public title
Ranolazine effects on angina pectoris in patients with coronary artery bridge
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian origin
No history of organ damage, heart failure or renal failure
Willingness to participate in research
Angina or dyspnea on exertion or at rest
No coronary artery disease (less than 50% stenosis in all epicardial coronary arteries)
Exclusion criteria:
Not willing to keep participating in the trial
patients younger than 18 years
Liver failure, long QT, renal failure
Using CYP3A inhibitors such as Diltiazem, Verapamil, Ketoconazole, Macrolides and protease inhibitors
Patient who are using medication that cause QT prolongation
Pregnancy or lactation
Parkinson's disease
Life expectancy less than 6 months
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization, using table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
All investigators, patients, and follow-up team members were kept unaware of the treatment assignments throughout the study, ensuring a non-biased controlled study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2023-06-17, 1402/03/27
Ethics committee reference number
IR.SUMS.MED.REC.1402.290
Health conditions studied
1
Description of health condition studied
Myocardial bridge in coronary arteries
ICD-10 code
Q24.5
ICD-10 code description
Malformation of coronary vessels
Primary outcomes
1
Description
Severity of chest pain
Timepoint
At the beginning- 6 month later
Method of measurement
Seattle Angina Questionnaire (SAQ) and The Duke Activity Status Index (DASI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, in addition to beta-blocker Bisoprolol Fumarate (Concor) Tablet 2.5 mg daily (Brand: Abidi), Ranolazine Tablet 500 mg daily (Xinaro 500mg) is prescribed for 6 months.
Category
Treatment - Drugs
2
Description
Control group: Bisoprolol Fumarate (Concor) 2.5 mg daily (Brand: Abidi) and Placebo is given to this group for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
shiraz university of medical science
Full name of responsible person
Nasim Kheirandish
Street address
shiraz university of medical science, zand street, shiraz
City
shiraz
Province
Fars
Postal code
7196855794
Phone
+98 21 3631 5972
Email
nasim.kheirandish3@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempur
Street address
zand
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir%20
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Yaser Rahbarian
Position
Cardiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Shiraz University of Medical Science, Zand street
City
Shiraz
Province
Fars
Postal code
7196855794
Phone
+98 71 3233 4196
Email
y.rahbaryan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamed Bazrafshan
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Shiraz University of Medical Science, Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
hamedbazrafshan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasim Kheirandish
Position
general practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
Shiraz University of Medical Science, Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 21 3631 5972
Email
nasim.kheirandish3@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only a part of data like primary outcome can be shared.
When the data will become available and for how long
The access period starts 1 year after the publication time of results
To whom data/document is available
This data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The data will be made available to researchers for further studies or more advanced analysis.
From where data/document is obtainable
Researchers can send an email regarding the request for the data of our study to Dr. Hamed Bazrafshan. Email: Hamedbazrafshan@yahoo.com
What processes are involved for a request to access data/document
The researchers can request for this study's data through an e-mail one year after the publication data of this study in one of the pee-reviewed journals.