Protocol summary

Study aim
The effect of Pentoxifylline in improving myocardial damage in ST-segment elevation myocardial infarction patients treated with primary angioplasty is determined.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 70 patients. For randomization, the sequence of random numbers prepared with SPSS software was used.
Settings and conduct
The current study is a double-blind clinical trial that was conducted in the CCU department of Baqiyatullah Azam Hospital on 70 patients. After obtaining informed consent from the patients, the available patients were checked in terms of the entry criteria and were assigned to two control and intervention groups using white and black cards sorted based on the sequence of randomization. Then Pentoxifylline was used in the intervention group, and placebo was used in the control group.
Participants/Inclusion and exclusion criteria
Patients with myocardial infarction with ST segment elevation who refer to Baqiyatullah Hospital in Tehran and are candidates for percutaneous coronary interventions, with criteria: chest pain for more than 30 minutes and less than 12 hours with ST segment elevation at the point J in ECG for more than 1 mm in at least two consecutive leads, successful PCI, sinus rhythm and informed consent to participate in the study are included.
Intervention groups
receiving pentoxifylline drug; Three 400 mg tablets, generic form, immediately before treatment with percutaneous coronary interventions
Main outcome variables
In this study, the effect of Pentoxifylline drug on cardiac isozymes, including Troponin I, Creatine Phosphokinase, C-reactive protein and interleukin-6, was measured in order to investigate the recovery of myocardial damage.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240323061353N1
Registration date: 2024-06-24, 1403/04/04
Registration timing: prospective

Last update: 2024-06-24, 1403/04/04
Update count: 0
Registration date
2024-06-24, 1403/04/04
Registrant information
Name
Seyedjavad ِDavari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4445 6022
Email address
seyedjavad71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-29, 1403/04/09
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Pentoxifylline in improvement Myocardial Injury in Patients with ST-elevation myocardial infarction treated by primary percutaneous coronary intervention
Public title
Effect of Pentoxifylline in improvement Myocardial Injury in Patients with ST-elevation myocardial infarction treated by primary percutaneous coronary intervention
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of STEMI, as chest pain lasting more than 30 minutes and less than 12 hours with ST-segment elevation at the J point on the ECG for more than 1 mm in at least two consecutive leads Precancerous coronary intervention successful sinus rhythm Informed consent to participate in the study
Exclusion criteria:
Recent history (within 3 months) of coronary artery bypass grafting Receive thrombolytic therapy Recent electrophysiological interventions of the heart Cardiogenic shock at the time of presentation History of kidney failure (Creatinine > 2.5 mg/dL) Allergy and contraindication to aspirin, clopidogrel or pentoxifylline Those who are pregnant or breastfeeding Dissatisfaction and those who want to stop the study at any time
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
For random allocation, white and black cards were used, which were arranged based on the sequence of random numbers prepared with SPSS software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the researcher, as well as the study participants, were not aware of the type of drug.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatullah Hospital
Street address
Mollasadra St., Vanak Square, Tehran city
City
Tehran
Province
Tehran
Postal code
1435915375
Approval date
2023-12-11, 1402/09/20
Ethics committee reference number
IR.BMSU.BAQ.REC.1402.083

Health conditions studied

1

Description of health condition studied
Myocardial infarction
ICD-10 code
I21.3
ICD-10 code description
ST elevation (STEMI) myocardial infarction of unspecified site

Primary outcomes

1

Description
Troponion I
Timepoint
Upon entering the emergency room and then 8, 16 and 32 hours after revascularization treatment.
Method of measurement
Blood test

2

Description
interleukin 6
Timepoint
On arrival in the emergency room and 48 hours and 15 days after revascularization treatment
Method of measurement
Blood Test

3

Description
hs-CRP
Timepoint
On arrival in the emergency room and 48 hours and 15 days after revascularization treatment
Method of measurement
Blood test

4

Description
CPK
Timepoint
On arrival to the emergency department as a baseline sample and every 8 hours to 48 hours after revascularization treatment
Method of measurement
Blood test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Receive 1200 mg oral pentoxifylline (maximum daily dose of pentoxifylline; three 400 mg tablets, generic form) immediately before PCI treatment
Category
Treatment - Drugs

2

Description
Control group: Standard treatment for STEMI is according to the American College of Heart Foundation (ACCF)/American Heart Association (AHA) guidelines. Includes: bolus heparin 60 units/kg followed by a continuous infusion of 12 units/kg/min with a target aPTT of 50-70 seconds, a loading dose of 162-325 mg of enteric-coated, chewable aspirin, as well as 300 mg of clopidogrel plus intravenous nitrate or sublingual and morphine sulfate or pethidine.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyat Allah Al-Azam Hospital
Full name of responsible person
Seyed Javad Davri
Street address
Mulla Sadra Street, Vanak Square, Tehran Town
City
Tehran
Province
Tehran
Postal code
1435915375
Phone
+98 21 4445 6022
Email
seyedjavad71@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Nematullah Jalini
Street address
St., Vanak square, Tehran city
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 4445 6022
Email
Seyedjavad71@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Alireza Nasiri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Mollasadra street, Vanak square,Tehran city
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 4445 6022
Email
seyedjavad71@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Alireza Nasiri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Mollasadra street, Tehran city, Vanak square
City
Tehran
Province
Tehran
Postal code
1435915375
Phone
+98 21 4445 6022
Email
seyedjavad71@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyed Javad Davrai
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Mollasadra street, Vanak square, Tehran city
City
Tehran
Province
Tehran
Postal code
1435915375
Phone
+98 21 4445 6022
Email
seyedjavad71@gmail.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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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