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Comparison the effect of Single Dose (80 mg, Daily) versus Divided Dose (80 mg, BID) of Acetylsalicylic Acid on endothelial function in diabetic patients (Type2): A Randomized Clinical Trial

Protocol summary

Study aim
Comparison of the effect of divided dose Acetylsalicylic Acid (80 milligram, BID) and single dose Acetylsalicylic Acid (80 milligram, daily) on endothelial function in patients with diabetes mellitus
Design
In this open labeled randomized clinical trial, 40 newly diagnosed patients with diabetes mellitus without complication, older than 40 year old and ASCVD score more than 7.5 will enroll. Patients randomly divided into two group using Random Allocation Software. Intervention group will receive Acetylsalicylic Acid, 80 milligram twice and control group will receive Acetylsalicylic Acid, 80 milligram daily, orally. Flow Mediated Dilation will measure in patients just before treatment, one hour after first dose and six days after treatment ( one hour before and one hour after last dose).
Settings and conduct
The study will be conducted at Chamran Hospital, Isfahan, Iran. patients who had inclusion criteria, will enroll the study. Flow Mediated Dilation will measure in patients just before treatment, one hour after first dose and six days after treatment ( one hour before and one hour after last dose).
Participants/Inclusion and exclusion criteria
Newly diagnosed patients with diabetes mellitus without complication, older than 40 years and ASCVD score more then 7.5
Intervention groups
Intervention group will receive Acetylsalicylic Acid, 80 milligram twice and control group will receive Acetylsalicylic Acid, 80 milligram daily, orally.
Main outcome variables
Flow Mediated Dilation (FMD)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191101045301N1
Registration date: 2020-02-12, 1398/11/23
Registration timing: prospective

Last update: 2020-02-12, 1398/11/23
Update count: 0
Registration date
2020-02-12, 1398/11/23
Registrant information
Name
saeide Bahrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3333 4396
Email address
saeide.bahrani@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Single Dose (80 mg, Daily) versus Divided Dose (80 mg, BID) of Acetylsalicylic Acid on endothelial function in diabetic patients (Type2): A Randomized Clinical Trial
Public title
Comparison the effect of Single Dose versus Divided Dose of ASA on endothelial function in diabetic patients (Type2): A Randomized Clinical Trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 40 year Diabetes Melitus ASCVD Score more than 7.5
Exclusion criteria:
Any cardiovascular disease Any cerebrovascular disease Any cardiac arrhythmia Any anti platelet or anticoagulant consumption Suffering from acute or chronic infection Platelet disturbance or bleeding tendency NSAIDs consumption in recent 14 days Platelet count less than 120000 Smoking Chronic Kidney Disease (CKD) GI Bleeding Pregnancy
Age
From 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by Random Allocation Software
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
Iran National Committee for ethics in Biomedical Research
Street address
13th floor, Block A, Ministry of Health and Medical Education, Siamye Iran ave.
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2020-01-04, 1398/10/14
Ethics committee reference number
IR.MUI.MED.REC.1398.502

Health conditions studied

1

Description of health condition studied
Newly diagnosed Diabetes mellitus without complication
ICD-10 code
E11.9
ICD-10 code description
Type 2 diabetes mellitus without complications

Primary outcomes

1

Description
Flow Mediated Dilation
Timepoint
Bse line, 1 hour after treatment,6 days after treatment( one hour before last dose), 6 days after treatment( one hour after last dose)
Method of measurement
Echocardiography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Tab ASA, 80 mg, BID, PO (Osve Company, Iran)
Category
Treatment - Drugs

2

Description
Control group: Tab ASA, 80 mg, daily, PO (Osve Company, Iran)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran hospital
Full name of responsible person
Saeide Bahrani
Street address
Cardiology department office, Chamran Hospital, Salman Farsi St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3261 1406
Email
Saeide.bahrani@resident.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooye javanmard
Street address
Isfahan University of Medical Sciences, Hezar jarib Ave., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Teimouri-jervekani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Cardiology department office, Chamran Hospital, Salman Farsi St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8158388994
Phone
+98 31 3261 1406
Email
zari.t.j@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Teimouri-jervekani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Cardiology department office, Chamran Hospital, Salman Farsi St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8158388994
Phone
+98 31 3261 1406
Email
zari.t.j@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saeide Bahrani
Position
Cardiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Cardiology department office, Chamran Hospital, Slaman farsi St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8158388994
Phone
+98 31 3261 1406
Email
saeide.bahrani@resident.mui.ac.ir

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
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
Title and more details about the data/document
All data will share after removing patients' identification data.
When the data will become available and for how long
Simultaneously with publishing the results
To whom data/document is available
to receive data, researchers need to send request.
Under which criteria data/document could be used
to use in a meta-analysis
From where data/document is obtainable
Sending email to Zahra Teimouri-jervekani Email address: zari.t.j@gmail.com
What processes are involved for a request to access data/document
Formal request from the institute/university is needed to receive data. Contact and personal information are needed.
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