Evaluation of the effect of oral Ranolazine on the clinical symptoms of patients with slow flow coronary arteries
Design
Phase 2 randomized double-blinded placebo parallel clinical trial on 48 patients
Randomization using www.sealedenvelope.com
Settings and conduct
This study will perform in the heart ward and clinic of Ghaem Hospital in Mashhad. Patients are randomly assigned to Ranolazine and placebo groups. Patients and the main researcher are unaware of groups assignation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Consent to admission to the study; Age more than 30 years old; Patients with slow coronary flow with a corrected TIMI frame count of more than 27 frames per second
Exclusion criteria: Cardiovascular disease other than mild coronary atherosclerosis; intolerance or allergy to Ranolazine; congenital heart disease.
Intervention groups
Intervention group: Receiving common treatments (including aspirin, statins, beta-blockers and ACEIs) + oral Ranolazine 500 mg twice daily for 2 months/ Placebo group: receiving common treatments + placebo tablet once daily for 2 months.
Placebo group: Receiving common treatments + placebo tablet twice daily for 2 months.
Main outcome variables
Changes in the score of quality of life according to the EuroQol-VAS (0-100; 100 is the best quality of life and 0 is the worst quality of life); Number of times of pain during the day; Duration of pain (minutes); Pain intensity following activity according to the Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris, all evaluated before intervention and 1, and 2 months after beginning the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220516054874N6
Registration date:2022-09-24, 1401/07/02
Registration timing:prospective
Last update:2022-09-24, 1401/07/02
Update count:0
Registration date
2022-09-24, 1401/07/02
Registrant information
Name
Vafa Baradaran Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2301
Email address
baradaranrv@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-07, 1401/07/15
Expected recruitment end date
2024-10-06, 1403/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral Ranolazine on the clinical symptoms of patients with slow flow coronary arteries
Public title
Evaluation of the effect of Ranolazine on patients with slow flow coronary arteries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to admission to the study
Age more than 30 years old
Patients who have less than 50% stenosis in each of the 3 main coronary arteries in their coronary angiography and have delayed filling in at least one of the coronary arteries and have slow coronary flow in a corrected TIMI frame count of more than 27 frames per second
Exclusion criteria:
Intolerance or allergy to Ranolazine
History of known congenital heart disease
History of any cardiovascular diseases other than mild coronary atherosclerosis
Age
From 30 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
The blocked randomization method is used.
The volume of each block will be four. Then the list of blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 12 blocks according to the sample size of 48. Then random numbers between 1 and 12 are selected according to the randomization site Randomaization.com and finally, the treatment allocation list is determined based on the random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Using sealed envelopes
Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups. Finally, after analyzing the data, the researcher who prepared the packages will reveal the codes A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic's committee of School of Medicine, Mashhad University of Medical Sciences
Street address
Faculty of Medicine, Ferdowsi University complex, Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2022-05-31, 1401/03/10
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.291
Health conditions studied
1
Description of health condition studied
Coronary slow flow syndrome
ICD-10 code
I20.8
ICD-10 code description
Other forms of angina pectoris
Primary outcomes
1
Description
Changes in the score of quality of life according to the EuroQol-VAS scale (0-100; 100 is the best quality of life and 0 is the worst quality of life)
Timepoint
Before intervention and 1, and 2 months after beginning the intervention
Method of measurement
According to the EuroQol-VAS scale (0-100; 100 is the best quality of life and 0 is the worst quality of life)
Secondary outcomes
1
Description
Frequent pain during the day
Timepoint
Before intervention and 1, and 2 months after beginning the intervention
Method of measurement
Frequent pain during the day
2
Description
Duration of pain in minutes
Timepoint
Before intervention and 1, and 2 months after beginning the intervention
Method of measurement
Duration of pain in minutes
3
Description
Pain intensity based on activity according to Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris
Timepoint
Before intervention and 1, and 2 months after beginning the intervention
Method of measurement
According to Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris
Intervention groups
1
Description
Intervention group: Patients who have less than 50% stenosis in each of the 3 main coronary arteries in their coronary angiography and have delayed filling in at least one of the coronary arteries and have slow coronary flow in a corrected TIMI frame count of more than 27 frames per second are considered to have slow coronary artery disease. They received routine treatment (including aspirin, statins, beta-blockers and angiotensin-converting enzyme inhibitors) along with oral ranolazine at a dose of 500 mg twice daily for two months.
Category
Treatment - Drugs
2
Description
Control group: Intervention group: Patients who have less than 50% stenosis in each of the 3 main coronary arteries in their coronary angiography and have delayed filling in at least one of the coronary arteries and have slow coronary flow in a corrected TIMI frame count of more than 27 frames per second are considered to have slow coronary artery disease. They received routine treatment (including aspirin, statins, beta-blockers and angiotensin-converting enzyme inhibitors) along with oral placebo tablet with shape, size, and color similar to ranolazine twice daily for two months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital in Mashhad
Full name of responsible person
Dr. Bahram Shahri
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3801 2739
Email
ShahriB@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayour-Mobarhan
Street address
Qurashi Building, Next to Hoveyzeh Cinema, University Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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