Evaluation of the efficacy and side effects of antiplatelet and anticoagulant therapy in patients with coronary artery ectasia.
Design
A Clinical trial with control group, parallel groups, single blinded, randomized, phase 2-3 on 148 patients.
Settings and conduct
Patients who were diagnosed with coronary artery ectasia after performing angiography at Ayatollah Mousavi Hospital in Zanjan are examined.
We classify patients who need stenting in one category and patients who do not need stenting in another. Then the patients in the first group (stenting) were randomly divided into two groups and for one group prescribed a combination of two antiplatelet drugs (DAPT) and one anticoagulant drug and for the other group only two We prescribe antiplatelet drug (DAPT).
Also, in the second group ( non-stenting) are randomly divided into two categories. For the first group of these patients we prescribed two anti platelet drugs and for the second group we prescribed an anti platelet and an anticoagulant drug.
In this study, rivaroxaban 2.5 mg twice daily was used as an anticoagulant, aspirin 80 mg daily, and clopidogrel 75 mg daily as an antiplatelet drug.
The analyzer is not aware of the drugs used in each group and study groups are provided to them in a coded form.
Participants/Inclusion and exclusion criteria
Coronary artery ectasia , renal failure and hepatic failure , history of taking anticoagulants.
Intervention groups
When comparing the use of two anti platelet drugs (DAPT) and one anticoagulant drug with only two anti platelet drugs in patients with coronary artery ectasia requiring stent.
When comparing the use of two anti platelet drugs with one anti platelet drug and one anticoagulant drug in patients with coronary artery ectasia without stent.
Main outcome variables
Myocardial infarction, hemorrhagic stroke, mortality, major and minor bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210110049984N1
Registration date:2021-10-25, 1400/08/03
Registration timing:registered_while_recruiting
Last update:2021-10-25, 1400/08/03
Update count:0
Registration date
2021-10-25, 1400/08/03
Registrant information
Name
Behnoosh Poorkarimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 0001
Email address
Info.behnoosh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-19, 1400/06/28
Expected recruitment end date
2022-06-18, 1401/03/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy and side effects of anti platelets in comparison with anti coagulation in coronary artery ecstasia patients
Public title
Efficacy and side effects of antiplatelets with anticoagulants in Coronary Artery Ectasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ectatic coronary artery in angiography
Exclusion criteria:
History of taking anticoagulant drug
Coagulation disorder
Hepatic failure
Renal failure
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
148
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in this study is a simple randomization which also uses individual units.Individuals in this study are divided into 4 groups without special bias.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study groups are coded however the analyzer is not aware of the drugs used in each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of zanjan University of Medical Sciences
Street address
No. 128, Negin street, opposite the intersection of Negin North, Negin town
City
Zanjan
Province
Zanjan
Postal code
۴۵۱۴۹۹۴۴۱۳
Approval date
2021-09-19, 1400/06/28
Ethics committee reference number
IR.ZUMS.REC.1400.238
Health conditions studied
1
Description of health condition studied
Ectatic coronary artery
ICD-10 code
2021 ICD-1
ICD-10 code description
Abnormal balloon- or sac-like dilatation in the wall of coronary vessels. Most coronary aneurysms are due to coronary atherosclerosis, and the rest are due to inflammatory diseases
Primary outcomes
1
Description
Myocardial infarction
Timepoint
Up to one year from the intake of the medication
Method of measurement
Questionnaire
2
Description
Stroke
Timepoint
Up to one year from the intake of the medication
Method of measurement
Questionnaire
3
Description
Mortality
Timepoint
Up to one year from the intake of the medication
Method of measurement
Questionnaire
4
Description
Major bleeding
Timepoint
Up to one year from the intake of the medication
Method of measurement
Questionnaire
5
Description
Minor bleeding
Timepoint
Up to one year from the intake of the medication
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with coronary artery ectasia who have undergone stenting are treated with aspirin 80 mg daily, clopidogrel 75 mg daily, and rivaroxaban 2.5 mg twice daily for one year.
Category
Treatment - Drugs
2
Description
Intervention group:Patients with non-stenting coronary artery ectasia are treated with aspirin 80 mg daily and rivaroxaban 2.5 mg twice daily for one year.
Category
Treatment - Drugs
3
Description
Control group: Patients with coronary artery ectasia who have undergone stenting are treated with aspirin 80 mg daily and clopidogrel 75 mg daily for one year.
Category
Treatment - Drugs
4
Description
Control group: Patients with non-stenting coronary artery ectasia are treated with aspirin 80 mg daily and clopidogrel 75 mg daily for one year.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital in Zanjan
Full name of responsible person
Behnoush pourkarimi fatideh
Street address
No. 128, Negin street, opposite the intersection of Negin North, Negin town
City
زنجان
Province
Zanjan
Postal code
4514994413
Phone
+98 24 3313 0001
Email
info.behnoosh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Behnoush pourkarimi fatideh
Street address
No. 128, Negin street, opposite the intersection of Negin North, Negin town
City
Zanjan
Province
Zanjan
Postal code
4514994413
Phone
+98 24 3313 0001
Email
info.behnoosh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Personal
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Behnoush pourkarimi fatideh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
No. 128, Negin street, opposite the intersection of Negin North, Negin town
City
Zanjan
Province
Zanjan
Postal code
4514994413
Phone
+98 24 3313 0001
Email
info.behnoosh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Behnoush pourkarimi fatideh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
No. 128, Negin street, opposite the intersection of Negin North, Negin town
City
Zanjan
Province
Zanjan
Postal code
4514994413
Phone
0982433130001
Email
info.behnoosh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Behnoush pourkarimi fatideh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
No. 128, Negin street, opposite the intersection of Negin North, Negin town
City
Zanjan
Province
Zanjan
Postal code
4514994413
Phone
+98 24 3313 0001
Email
info.behnoosh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
After analyzing the data and defending the dissertation, it will be sent as an article to reputable journals with the preservation of patients' information for publication.
When the data will become available and for how long
After completing the plan
To whom data/document is available
All individuals, legal, academic, non-academic
Under which criteria data/document could be used
In case of coordination with the responsible person and written request and with the permission of patients
From where data/document is obtainable
By email to the project manager
info.behnoosh@gmail.com
What processes are involved for a request to access data/document
E-mail or correspondence to the project manager, inserting personal and organizational details and specifying the application of the information received will be answered within a week.