1. Home
  2. Approved trials
  3. » فارسی

The effect of Aspirin, Statin, Nitrate drug regimen on the quality of life in patients with Coronary slow flow disease and its comparison with the addition of Nicorandil

Protocol summary

Study aim
Comparison of the effect of three common drugs (Aspirin, Statin, Nitrate) with three common drugs plus Nicorandil on the quality of life in patients with slow flow coronary syndrome
Design
An open-label randomized controlled clinical trial study with two parallel arms was conducted to evaluate the effectiveness of nicorandil along with the treatment of three common drugs (aspirin, statin, nitrate) in 56 patients with symptomatic Coronary slow flow syndrome. Randomized blocks of 4 are used for randomization. Random allocation software version 2 is used to create random permutations of 4 (random blocks of 4).
Settings and conduct
This clinical trial study is conducted at Bo Ali Sina University Hospital in Qazvin on patients with CSFP. The disease is diagnosed using angiography. Patients were randomly assigned to one of two groups, a three-drug treatment group with 80 mg Aspirin, 20 mg Atorvastatin daily, and 2.6 mg Nitroglycerin every 12 hours, and the three-drug treatment group plus Nicorandil 10 mg every 12 hours. The quality of life in patients is checked at the beginning of the study and then two months after drug treatment using the McNew quality of life questionnaire.
Participants/Inclusion and exclusion criteria
Patients who were candidates for coronary angiography based on clinical symptoms, changes in electrocardiography, echocardiography, myocardial perfusion scan or exercise test, and other causes rather than myocardial ischemia and infarction such as arrhythmia or conduction disorders were included in the study.
Intervention groups
Group of three common drugs regimen (Aspirin, Statin, Nitrate) Group of three common drugs plus nicorandil
Main outcome variables
The primary outcome in this study is the reduction of clinical symptoms and the secondary outcome is the improvement of patient's quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221228056964N1
Registration date: 2023-01-17, 1401/10/27
Registration timing: prospective

Last update: 2023-01-17, 1401/10/27
Update count: 0
Registration date
2023-01-17, 1401/10/27
Registrant information
Name
Hamidreza Javadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 2931
Email address
javadi.hr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Aspirin, Statin, Nitrate drug regimen on the quality of life in patients with Coronary slow flow disease and its comparison with the addition of Nicorandil
Public title
The effect of adding Nicorandil to the three-drug regimen on the quality of life in patients with Coronary slow blood flow disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred to Bu-Ali Sina Referral Center who are candidates for coronary angiography based on clinical criteria, echocardiography, or other causes except for acute myocardial infarction or its history and complications (such as arrhythmias or conduction disorders), and then using The relevant criteria for diagnosing slow flow coronary syndrome are set for them.
Exclusion criteria:
Patients with a history of Myocardial infarction, Coronary artery bypass graft surgery, Percutaneous coronary intervention, Heart failure, Valvular heart disease, connective tissue disorders, Atrio-ventricular conduction disorders, Chronic obstructive pulmonary disease, Electrolyte disturbance, Chronic kidney disease, Anemia, and Systemic Hypertension are excluded from the study. After coronary angiography, patients with coronary slow flow due to secondary causes including Coronary artery ectasia, Coronary artery aneurysm, Coronary artery spasm, Air embolism during the procedure, and Congenital anomalies of coronary arteries are excluded from the study. Patients who do not agree to participate in the plan for any reason or decide to withdraw from the plan at any time.
Age
From 20 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are allocated to one of the two intervention groups using the random block sampling method. Random allocation software version 2 with a fixed size of 4 is used to generate randomized blocks. The principal investigator and the patients are unaware of the assigned treatment group
Blinding (investigator's opinion)
Not 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 Qazvin University of Medical Sciences
Street address
Department of Cardiovascular Diseases, Bu Ali Sina hospital, Bu Ali Sina Street
City
Qazvin
Province
Qazvin
Postal code
3413786165
Approval date
2022-12-21, 1401/09/30
Ethics committee reference number
IR.QUMS.REC.1401.270

Health conditions studied

1

Description of health condition studied
Slow flow coronary disease
ICD-10 code
I20.8
ICD-10 code description
Other forms of angina pectoris

Primary outcomes

1

Description
Reduction of patients' symptoms
Timepoint
Before and after the end of the medication period
Method of measurement
Clinical signs and symptoms

Secondary outcomes

1

Description
Improving the patients quality of life
Timepoint
Before and after the end of the medication period
Method of measurement
McNew Quality of life Questionnaire

Intervention groups

1

Description
First arm: conventional three-drug regimen of aspirin 80 mg/day, statin 20 mg/day, and nitroglycerin 2.6 mg twice daily for 2 months.
Category
Rehabilitation

2

Description
Second arm: a conventional regimen of three drugs (Aspirin 80 mg/day, Statin 20 mg/day, and Nitroglycerin 2.6 mg twice daily) along with 10 mg of Merck's Adancor brand Nicorandil twice daily
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Bu Ali Sina Hospital
Full name of responsible person
Hamidreza Javadi
Street address
Department of Cardiovascular Diseases, Bu Ali Sina Hospital, Bu Ali Sina St.
City
Qazvin
Province
Qazvin
Postal code
34137,86165
Phone
+98 28 3333 2930
Email
javadi.hr@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Sayad Mehdi Mir Hashmei
Street address
Mavadat St., Shahid Beheshti Blvd., Research and Technology Vice-Chancellor of Qazvin University of Medical Sciences, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3336 8124
Fax
+98 28 3335 0056
Email
researchdpt@qums.ac.ir
Web page address
https://vcr.qums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Hamidreza Javadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Department of Cardiovascular Diseases, Bu Ali Sina hospital, Bu Ali Sina Street
City
Qazvin
Province
Qazvin
Postal code
34137-86165
Phone
+98 28 3333 2930
Fax
Email
javadi.hr@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hamidreza Javadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Department of Cardiovascular Diseases, Bu Ali Sina hospital, Bu Ali Sina Street
City
Qazvin
Province
Qazvin
Postal code
34137,86165
Phone
+98 28 3333 2930
Email
javadi.hr@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hamidreza Javadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Department of Cardiovascular Diseases, Bu Ali Sina hospital, Bu Ali Sina Street
City
Qazvin
Province
Qazvin
Postal code
34137 86165
Phone
+98 28 3333 2930
Fax
Email
javadi.hr@gmail.com

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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Demographic data and outcome of study can be shared
When the data will become available and for how long
In the end of study, 1402
To whom data/document is available
It is available for researchers
Under which criteria data/document could be used
For further research, with the approval of the University Ethics Committee
From where data/document is obtainable
Correspond with the researchers by e-mail 1- Dr. Hamidreza Javadi, Email: javadi.hr@gmail.com 2. Dr. Amir Javadi, Email: Javadi_a@yahoo.com
What processes are involved for a request to access data/document
One working week after correspondence
Comments
Loading...