Evaluating the role of intravenous Pentoxifylline administration on increasing primary percutaneous coronary intervention (PPCI) success in ST elevation myocardial infarction (STEMI) patient
Investigating the role of pentoxifylline on success of primary PCI in patients with STEMI
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment that 320 patients diagnosed with Acute STEMI to perform Primary PCI are introduced to the Department of Cardiology, in the Heart Center of Tehran, who have criteria for entry will be included in the study. Patients, are divided to the two groups of 160 A and B, based on Permuted Block Randomization randomly.
Settings and conduct
This is a selective interventional study in which 320 patients diagnosed with Acute STEMI to perform Primary PCI are introduced to the Department of Cardiology, Tehran University of Medical Sciences, which, if they have criteria for entering the study, are selected and entered Will be studied
Participants/Inclusion and exclusion criteria
Entry requirements (Inclusion Criteria): patient older than 18 years of age who becomes a Primary PCI candidate؛ chest pain for less than or equal to 12 hours؛ Obtain consent from the patient؛ Exclusion Criteria:Patients unwilling to participate; Age less than 18; Start angina more than 12 hours; CPR before transition to cath-lab; Patients with history of cardiac transplantation; Patients with history of PCI or CABG in last month; Patients who received thrombolytic; Current use of pentoxyfilline; Use of ketorolac in last 24 hours
Intervention groups
Patients are categorized randomly according to defined criteria in two groups of 160 patients. In one group, 50 mg IV bolus, then 50 mg in 30 minutes infusion of pentoxifylline, in addition to other routine treatments will be given. In the other group, placebo is given. Then, effects of pentoxifylline on coronary flow and myocardial perfusion in the two groups will be investigated.
Main outcome variables
Coronary Flow Rate؛ Myocardial perfusion rate؛
General information
Reason for update
Acronym
PENTOS
IRCT registration information
IRCT registration number:IRCT20120111008698N24
Registration date:2019-08-02, 1398/05/11
Registration timing:registered_while_recruiting
Last update:2019-08-02, 1398/05/11
Update count:0
Registration date
2019-08-02, 1398/05/11
Registrant information
Name
Azita Hajhossein Talasaz
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66954709
Email address
atalasaz@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-20, 1398/03/30
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the role of intravenous Pentoxifylline administration on increasing primary percutaneous coronary intervention (PPCI) success in ST elevation myocardial infarction (STEMI) patient
Public title
Evaluating the role of intravenous pentoxifylline on successfullness of stenting in patients with myocardial infarction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 18 who are candidate for primary PCI.
Pain or chest discomfort greater than or equal to 20 minutes, less than or equal to 12 hours, and ST elevation ≥ 1 mm in the adjacent limb leads and precordial leads except for V2, V3, or ST elevation ≥ 2 mm in V2, V3 in men or ST height ≥ 1.5 mm in V2, V3 in women.
Obtain informed consent from all patients before enrollment.
Exclusion criteria:
Start angina more than 12 hours
CPR before transition to cath-lab
Patients with history of cardiac transplantation
Patients with history of PCI or CABG in last month
Patients who received thrombolytic
Current use of pentoxyfilline
Use of ketorolac in last 24 hours
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
320
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, Permuted Block randomization method was used individually. The randomized list of numbers 1 to 320 is randomly divided into two groups A or B, and the admitted patients are listed in group A or B, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, researchers and data analysers are unaware of the allocation of study groups, and those who prepare a draft article are also kept blind to the allocation of blind study groups Patients in group A or B and receiving a drug or placebo by the patient are unaware.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-03-10, 1396/12/19
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.4760
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
coronary blood flow and myocardial perfusion
Timepoint
during angiography
Method of measurement
TIMI flow criteria and observations during the angiography
Secondary outcomes
1
Description
hs-CRP
Timepoint
baseline and 48 hours after PCI
Method of measurement
blood sample
2
Description
TNT
Timepoint
baseline and 24 hours and 48 hours after PCI
Method of measurement
blood sample
3
Description
30 day MACE
Timepoint
one month after PCI
Method of measurement
follow-up visit or phone call
4
Description
TFC
Timepoint
during angiography
Method of measurement
TIMI frame count and observations during the angiography
5
Description
MBG
Timepoint
during angiography
Method of measurement
myocardial blush grade and observations during the angiography
Intervention groups
1
Description
Intervention group: Administration of intravenous pentoxifylline; 50 mg IV bolus, then 50 mg IV infusion in 30 minutes
Category
Treatment - Drugs
2
Description
Control group: Administration of solvent: NaCl 0.9 % serum
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
َAzita Hajhossein Talasaz
Street address
Tehran Heart Center
City
Tehran
Province
Tehran
Postal code
88029731
Phone
+98 21 8802 9261
Email
atalasaz@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Department of Environmental Health Engineering, School of Public Health, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3686
Email
atalasaz@razi.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hessam Kakavand
Position
Pharmacotherapy resident
Latest degree
Master
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacotherapy Department, Faculty of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
88029731
Phone
+98 21 8802 9261
Email
hessamkakavand@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Azita Hajhossein Talasaz
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacotherapy Department, Faculty of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
88029731
Phone
+98 21 2260 6951
Email
atalasaz@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hessam Kakavand
Position
Pharmacotherapy resident
Latest degree
Master
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacotherapy Department, Faculty of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
88029731
Phone
+98 21 2260 6951
Email
hessamkakavand@yahoo.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data such as primary and secondary outcome information
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
Conditions for using the data or documentation will be determined depending on the type of use, with the coordinator of the project
From where data/document is obtainable
E-mail: a-talasaz@tums.ac.ir
What processes are involved for a request to access data/document