Effectiveness of Atorvastatin on mortality and morbidity in catheterization procedures (Permcath)
Design
Clinical trial with control group and parallel groups, double blind, with using a permuted balanced block randomization method with the size of blocks 4 and 6, phase 3 on 228 patients, Random sequence will be generated by running an online program in sealed envelope website (https://www.sealedenvelope.com/).
Settings and conduct
The aim of this study is evalution of Atorvastatin effect on mortality and morbidity in catheterization procedures (Permcath). Locality of the study is in Amiralmomenin hospital of Arak city.Patients in statin group will receive Atorvastatin (Sobhan daru-Iran) 80 mg tablet 4 hours before surgery and 40 mg after surgery for 6 months daily. Patients in control group will receive the tablets with a similar shape of Atorvastatin 4 hours before surgery and in concomitant with patients in statin group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients older than 18 years old
Patients who have informed consent
Patients who need permanent dialysis
Sinus rhythm heart
Exclusion criteria:
Patients with chronic atrial fibrillation (AF)
Patients with liver failure
Patients with using class I and III of anti-arrhythmic drugs
Patients with using corticosteroid drugs
Patients with history of statin use in control group
Intervention groups
Patients in statin group will receive Atorvastatin (Sobhan daru-Iran) 80 mg tablet 4 hours before surgery and 40 mg after surgery for 6 months daily. Patients in control group will receive the tablets with a similar shape of Atorvastatin 4 hours before surgery and in concomitant with patients in statin group.
Main outcome variables
Patients mortality rate- Cardiac arrhythmia and myocardial infarction- Catheter site infection- Catheter function and stenosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201028049175N10
Registration date:2021-11-16, 1400/08/25
Registration timing:prospective
Last update:2021-11-16, 1400/08/25
Update count:0
Registration date
2021-11-16, 1400/08/25
Registrant information
Name
Shamim Valibak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
sh.valibak@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-18, 1400/08/27
Expected recruitment end date
2022-11-18, 1401/08/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Atorvastatin on mortality and morbidity in catheterization procedures (Permcath)
Public title
Effectiveness of Atorvastatin on reducing of death and illness after catheterization
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 18 years old
Patients who have informed consent
Patients who need permanent dialysis
Sinus rhythm heart
Exclusion criteria:
Patients with chronic atrial fibrillation (AF)
Patients with liver failure
Patients with using class I and III of anti-arrhythmic drugs
Patients with using corticosteroid drugs
Patients with history of statin use in control group
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
228
Randomization (investigator's opinion)
Randomized
Randomization description
Sequences web randomization (www.graphpad.com) dual group for creation of simple randomization and closed envelope method with random sequence (SNOSE) for concealment, will be used. Random sequences will be written on the cards and then sequentially put in the envelopes. In order to preserve random sequences, the outer surface of the envelopes are numbered, respectively. Finally, the lid of the envelopes will be pasted and placed inside the boxes, sequentially. At the time of participants registration, one of the envelopes will be open and the allocation group will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
All patients have informed consent to entrance to study, but they do not know about the kind of drugs have been received . The required drugs will be prescribed by the cardiologist, but the person who will analysis the data of patients outcomes will be unaware about the patients group and the kind of received drugs.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Assistance of research and technology, Payambare azam institution, Arak University of Medical Sciences, Basij square
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2021-10-10, 1400/07/18
Ethics committee reference number
IR.ARAKMU.REC.1400.171
Health conditions studied
1
Description of health condition studied
Complications after permanent catheterization (permcath)
ICD-10 code
T82.8
ICD-10 code description
Other specified complications of cardiac and vascular prosthetic devices, implants and grafts
Primary outcomes
1
Description
Frequency of cardiac arrhythmia
Timepoint
During 24 hours after catheterization
Method of measurement
Heart monitoring
2
Description
Frequency of myocardial infarction
Timepoint
During 24 hours after catheterization
Method of measurement
Heart monitoring
3
Description
Catheter site infection
Timepoint
Every 2 weeks till 6 month
Method of measurement
Physical examination
4
Description
Catheter function
Timepoint
Every 2 weeks till 6 month
Method of measurement
Physical examination
5
Description
Catheter stenosis
Timepoint
Every 2 weeks till 6 month
Method of measurement
Physical examination
6
Description
Mortality
Timepoint
During 24 hours after catheterization
Method of measurement
Number
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will receive Atorvastatin (Sobhan daru-Iran) 80 mg tablet 4 hours before surgery and 40 mg after surgery for 6 months daily.
Category
Prevention
2
Description
Control group: Patients will receive the tablets with a similar shape of Atorvastatin 4 hours before surgery and in concomitant with patients in statin group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Elham Farahani
Street address
Amiralmomenin hospital street, Basij square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
farahani13025@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Assistance of research and technology, Payambare azam institution, Arak University of Medical Sciences, Basij square
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Reza Shojaee
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Valie-asr square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
dr.reza.shojaee@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Elham Farahani
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Parastar square, Rah-ahan square, Shiroudi street
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 4715
Email
farahani13025@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Shamim Valibak
Position
General physician non-faculty
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Valiasr hospital, Valiasr square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
0098 86 32222003-8
Email
sh.valibak@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