Comparison of ezetimibe and atorvastatin treatment versus atorvastatin alone on Major Adverse Cardiac Events (MACE) after elective percutaneous coronary intervention (PCI)
Comparison of ezetimibe and atorvastatin treatment versus atorvastatin alone on Major Adverse Cardiac Events (MACE) after elective percutaneous coronary intervention (PCI) in Jorjani Angiogeraphy Center of Shahid Mohammadi Hospital
Design
In this study, 224 patients who refer to the Jorjani Center of Shahid Mohammadi Hospital in Bandar Abbas for PCI will be included in the study randomly if they have all the inclusion criteria and none of the exclusion criteria. They are then randomly divided into intervention and control groups.
Settings and conduct
This is a double blind clinical trial on patients refer to the Jorjani Center of Shahid Mohammadi Hospital in Bandar Abbas. Patients in the first group receive atorvastatin 40 mg and ezetimibe 10 mg daily. In the second group, the placebo is given in the same dose as in the original package, with the same shape, color and size, and in a manner, that is not differentiated from the original drug. Medications will be packaged in pre-prepared packages to patients so that patients and people who record the results of the study will be unaware of how the patients will be grouped.
Participants/Inclusion and exclusion criteria
Each patient who refers for PCI will be included if he/she meets all the inclusion criteria such as having normal hepatic enzymes and having negative troponin and does not meet any of the exclusion criteria such as having Inflammatory and rheumatologic diseases.
Intervention groups
Patients in the first group (intervention) receive atorvastatin 40 mg and ezetimibe 10 mg daily. In the second group (control), patients will receive atorvastatin 40 mg and 10 mg placebo instead of ezetimibe on a daily basis.
Main outcome variables
Myocardial infarction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171028037047N1
Registration date:2018-06-22, 1397/04/01
Registration timing:registered_while_recruiting
Last update:2018-06-22, 1397/04/01
Update count:0
Registration date
2018-06-22, 1397/04/01
Registrant information
Name
badri bijani
Name of organization / entity
Cardiovascular Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 7379
Email address
sh.abbaszadeh@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-04, 1396/11/15
Expected recruitment end date
2018-08-06, 1397/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ezetimibe and atorvastatin treatment versus atorvastatin alone on Major Adverse Cardiac Events (MACE) after elective percutaneous coronary intervention (PCI)
Public title
Comparison of ezetimibe and atorvastatin treatment versus atorvastatin alone on Major Adverse Cardiac Events
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for elective PCI
Having normal hepatic enzymes
Having negative troponin
Having LDL values greater than 100 mg / dL
Exclusion criteria:
Having Inflammatory and rheumatologic diseases
Having Infectious diseases
Having malignancies
Having high creatinine levels
Having abnormal liver enzymes
Pregnancy and lactation
Use of NSAIDs
Patient's dissatisfaction with participating in the study
Having ejection fraction below 30 (EF < 30)
Having myocardial infarction in the last month
The increase in troponin after PCI more than 5 times higher than normal maximum of 99 percentile
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
224
Randomization (investigator's opinion)
Randomized
Randomization description
In randomized manner, every patient who goes to PCI will be included in the study if they have all the inclusion criteria and no exclusion ones. Then by tossing coin they will be randomly divided into intervention and non intervention groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients in the first group receive atorvastatin 40 mg and ezetimibe 10 mg daily. In the second group, the placebo is given in the same dose as in the original package, with the same shape, color and size, and in a manner that is not differentiated from the original drug. Medications will be packaged in pre-prepared packages to patients so that patients and people who record the results of the study will be unaware of how the patients will be grouped.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Shahid Chamran Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2018-01-06, 1396/10/16
Ethics committee reference number
HUMS.REC.1396.133
Health conditions studied
1
Description of health condition studied
Myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Myocardial infarction
Timepoint
At intervals of 24 hours after PCI and one month after PCI
Method of measurement
ECG, hospital records, blood tests and imaging
Secondary outcomes
1
Description
Unstable angina
Timepoint
At intervals of 24 hours after PCI and one month after PCI
Method of measurement
ECG, hospital records, blood tests and imaging
2
Description
Death rate due to heart disease
Timepoint
At intervals of 24 hours after PCI and one month after PCI
Method of measurement
Hospital records
3
Description
Stroke rate
Timepoint
At intervals of 24 hours after PCI and one month after PCI
Method of measurement
ECG, hospital records, blood tests and imaging
4
Description
Stent thrombosis
Timepoint
At intervals of 24 hours after PCI and one month after PCI
Method of measurement
ECG, hospital records, blood tests and imaging
5
Description
CRP value
Timepoint
At intervals of 24 hours after PCI and one month after PCI
Method of measurement
Blood tests
Intervention groups
1
Description
Intervention group: Patients in this group receive atorvastatin 40 mg and ezetimibe 10 mg daily
Category
Treatment - Drugs
2
Description
Control group: Patients in this group receive atorvastatin 40 mg and placebo 10 mg daily. The placebo is given in the same dose as in the original package, with the same shape, color and size, and in a manner, that is not differentiated from the original drug
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Jorjani Angiogeraphy Center of Shahid Mohammadi Hospital of Bandar Abbas
Full name of responsible person
Shahin Abbas Zadeh
Street address
Islamic Republic of Iran Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 7000
Fax
+98 76 3334 5003
Email
sh-abaszadeh@yahoo.com
Web page address
http://www.shmh.hums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Shahin Abbas Zadeh
Street address
Shahid Chamran Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 7000
Fax
+98 76 3334 5003
Email
sh-abaszadeh@yahoo.com
Web page address
http://www.shmh.hums.ac.ir/
Grant name
Vice chancellor of research, Hormozgan University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Shahin Abbas Zadeh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Shahid Chamran Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 7379
Fax
+98 76 3331 0012
Email
sh-abaszadeh@yahoo.com
Web page address
http://www.shmh.hums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Shahin Abbas Zadeh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Shahid Chamran Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 7379
Fax
+98 76 3331 0012
Email
sh-abaszadeh@yahoo.com
Web page address
http://www.shmh.hums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Shahin Abbas Zadeh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Shahid Chamran Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 7379
Fax
+98 76 3331 0012
Email
sh-abaszadeh@yahoo.com
Web page address
http://www.shmh.hums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD