Comparing the effect of preprocedural loading dose of Arorvastatin vs Rrosuvastatin on prevalence of no-reflow and low TIMI flow in patients with ST elevation myocardial infarction undergoing primary percutaneous intervention
Comparing the effect of preprocedural loading dose of Atorvastatin vs Rosuvastatin on prevalence of no-reflow and low TIMI flow in patients with ST elevation myocardial infarction undergoing primary percutaneous intervention
Design
The randomized clinical trial had a control group, parallel groups trial without blinding, simple randomized, design of 160 patients. A random number table will be used for randomization.
Settings and conduct
The study will be done in Madani heart center of Tabriz. Patients will be treated with stat dose of Atorvastatin and Resvostatin before PPCI in emergency department without blinding.
Participants/Inclusion and exclusion criteria
The patients with acute myocardial infarction, regardless of the patients with chronic disease, history of acute myocardial infarction, ischemic heart disease.
Intervention groups
The first group of patients will receive 80 mg of Atorvastatin and the second group, 40 mg of Rosuvastatin.
Main outcome variables
No-reflow phenomen during the procedure, TIMI flow at the end of the procedure and mortality rates during hospitalization will be compared between two (intervention and control) groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200722048166N1
Registration date:2021-09-10, 1400/06/19
Registration timing:registered_while_recruiting
Last update:2021-09-10, 1400/06/19
Update count:0
Registration date
2021-09-10, 1400/06/19
Registrant information
Name
naser khalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3387 7616
Email address
dr_nkhalili@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-02, 1400/05/11
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of preprocedural loading dose of Arorvastatin vs Rrosuvastatin on prevalence of no-reflow and low TIMI flow in patients with ST elevation myocardial infarction undergoing primary percutaneous intervention
Public title
Atorvastatin and Rosuvastatin in myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who are candidates primary percutaneous intervention with acute myocardial infarction with ST-segment elevation are admitted to the emergency department of Madani heart center of Tabriz.
Exclusion criteria:
The patients with chronic disease such as inflammatory diseases, renal failure, a history of collagen and vascular disease, current active infection, blood diseases.
The patients with history of acute myocardial infarction or ischemic heart disease.
The patients with history of diabetes.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients are divided into two groups (Atorvastatin & Rosuvastatin) using sealed sachets. The researcher puts drug in the bags and randomly gives one of the sealed bags to each patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher is the only person who isn't blind in this study. The clinical caregiver randomly delivers packets containing medications to patients. The interventionist monitors and reports outcomes while is unaware of the type of medication that patients are receiving, and the patients are blind to which medication they have received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golbad
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-08-02, 1400/05/11
Ethics committee reference number
IR.TBZMED.REC.1400.394
Health conditions studied
1
Description of health condition studied
acute myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Rate of no-reflow at the during of PPCI
Timepoint
once at the during of the PPCI
Method of measurement
observational and based on individual skills
2
Description
Rate of TIMI flow at the end of PPCI
Timepoint
once at the end of the PPCI
Method of measurement
observational and based on individual skills
Secondary outcomes
1
Description
Rate of mortality
Timepoint
During hospitalization
Method of measurement
Observational
Intervention groups
1
Description
Control group: Patients in this group will be treated Atorostatin 80 mg, the first dose will be prescribed in the emergency department and the other doses will be continuous.
Category
Treatment - Drugs
2
Description
Intervention group: Patients in this group will be treated Resvostatin 40 mg, the first dose will be prescribed in the emergency department and the other doses will be continuous.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani heart center of Tabriz
Full name of responsible person
Naser Khalili
Street address
Univesity Main St
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3387 7616
Email
dr_nkhalili@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Univesity Main St
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
Samiei.moh@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Naser Khalili
Position
Assistant of fellowship
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Univesity Main St
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3387 7616
Email
dr_nkhalili@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Naser Aslan Abadi
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Univesity Main St
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 914 311 0844
Email
dr_nkhalili@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Naser Khalili
Position
Assistant of fellowship
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Univesity Main St
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3387 7616
Email
dr_nkhalili@yahoo.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
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