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Effect of N-acetylcystein in Myocardial Infarction

Primary Purpose

Acute Myocardial Infarction

Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
N-acetylcystein
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Myocardial Infarction

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Myocardial infarction patients who were candidate of primary PCI

Exclusion Criteria:

  • Rescue PCI
  • Emergency for cardiac bypass
  • Cardiogenic shock
  • Life expectancy less than 6 months
  • Age less than 18 years old
  • Uncontrolled hypertension
  • Thrombocytopenia
  • Malformation or aneurysm
  • Sever chronic kidney disease
  • Sever liver failure
  • Major surgery within 3 months
  • Unsatisfactory to enter the study

Sites / Locations

  • Teran Heart CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

control

N-acetylcystein

Arm Description

control This group is without N-acetylcystein : just receives standard treatment

receive N-acetylcystein in addition to standard treatment Ampoule 200 mg/ml

Outcomes

Primary Outcome Measures

Biomarkers of platelet activation (P selectin- CD40L-IL[Interleukin] 10- TGF[Transforming Growth Factor]-beta)

Secondary Outcome Measures

Cardiac Necrosis Biomarkers (CKMB, Troponin T)
difference between study and control group in 6 and 12 hrs after percutaneous coronary intervention
score of coronary blood flow(TIMI flow and MBG)
MACE (Major Adverse Cardiac Effect)
Defined as Need for Target Revascularization, Myocardial Infarction and Death

Full Information

First Posted
November 30, 2012
Last Updated
November 30, 2012
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01741207
Brief Title
Effect of N-acetylcystein in Myocardial Infarction
Official Title
Evaluation of N-acetylcystein on Biomarkers of Platelet Activation , Cardiac Necrosis and Coronary Reperfusion in Patients Undergoing Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
We designed this study to evaluate the effect of N-acetylcystein on biomarkers of platelet activation , cardiac necrosis and coronary reperfusion in patients undergoing percutaneous coronary intervention.
Detailed Description
Percutaneous coronary intervention(PCI) is one of the standard therapies for acute coronary syndrome. Despite major advances in PCI procedure, impaired myocardial perfusion frequently occurred after primary PCI and resulted in a larger infarct size and increased morbidity and mortality.Reperfusion injury process can be resulted in additional death of cardiomyocytes and it is suggested that oxidative stress is a contributing factor to induce reperfusion injury.During PCI,trauma occurs to the arterial endothelium, causes the activation and aggregation of platelets. It is estimated that approximately 25% of patients undergoing PCI have significant postprocedural creatinine kinase (CK)/creatinine kinase myocardial band (CK-MB) elevations and approximately 50% of patients have significant post-procedural troponin elevations. The most common complication of PCI is a cell damage to cardiomyocyte that can be diagnosed by postprocedure elevation of cardiac markers. N-acetylcystein have several positive effect on platelet and vascular function and infarct size. This study is a randomized clinical trial (RCT) evaluating the effect of N-acetylcystein on biomarkers of platelet activation and coronary reperfusion in patients undergoing percutaneous coronary intervention. Double blind randomized clinical trial on 100 patients in 2 groups (intervention & control) is conducted. Patients with confirmed ST-elevation myocardial infarction included in this study. Patients were excluded if they had: emergency for cardiac bypass; cardiogenic shock and rescue percutaneous coronary intervention. Patients in Intervention group were administered 100 mg/kg Iv bolus N-acetylcystein and then 480mg intracoronary and 10mg/kg/h over 12 hours after percutaneous coronary intervention and patients in control group received standard regimens. Primary outcome was platelet activation biomarkers assessment before and 24 hours after percutaneous coronary intervention and secondary outcome was effect of N-acetylcystein on CK-MB and high sensitive Troponin T, 6 and 12 hours after percutaneous coronary intervention.Patients were assessed for coronary blood flow after percutaneous coronary intervention with the use of TIMI flow and myocardial blush grade. Major adverse cardiac events (MACE) will be evaluated as a secondary endpoint after 30 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
control This group is without N-acetylcystein : just receives standard treatment
Arm Title
N-acetylcystein
Arm Type
Active Comparator
Arm Description
receive N-acetylcystein in addition to standard treatment Ampoule 200 mg/ml
Intervention Type
Drug
Intervention Name(s)
N-acetylcystein
Other Intervention Name(s)
EXI-NACE,NAC
Intervention Description
Active Comparator: N-acetylcystein receive N-acetylcystein in addition to standard treatment
Primary Outcome Measure Information:
Title
Biomarkers of platelet activation (P selectin- CD40L-IL[Interleukin] 10- TGF[Transforming Growth Factor]-beta)
Time Frame
Change from the baseline after 24 hours
Secondary Outcome Measure Information:
Title
Cardiac Necrosis Biomarkers (CKMB, Troponin T)
Description
difference between study and control group in 6 and 12 hrs after percutaneous coronary intervention
Time Frame
Change from the baseline after 12 hours
Title
score of coronary blood flow(TIMI flow and MBG)
Time Frame
Change from the baseline after percutaneous coronary intervention
Title
MACE (Major Adverse Cardiac Effect)
Description
Defined as Need for Target Revascularization, Myocardial Infarction and Death
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Myocardial infarction patients who were candidate of primary PCI Exclusion Criteria: Rescue PCI Emergency for cardiac bypass Cardiogenic shock Life expectancy less than 6 months Age less than 18 years old Uncontrolled hypertension Thrombocytopenia Malformation or aneurysm Sever chronic kidney disease Sever liver failure Major surgery within 3 months Unsatisfactory to enter the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Azita Hajhossein Talasaz, PharmD,BCPS
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Teran Heart Center
City
Tehran
ZIP/Postal Code
1711713138
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azita Hajhossein Talasaz
Phone
00989123779707
Email
atalasaz@razi.tums.ac.ir
First Name & Middle Initial & Last Name & Degree
Azita Hajhossein Talasaz, PharmD,BCPS
First Name & Middle Initial & Last Name & Degree
Yaser Jenab, MD
First Name & Middle Initial & Last Name & Degree
Mossafa Bahremand, MD
First Name & Middle Initial & Last Name & Degree
Azadeh Eshraghi, Pharm D
First Name & Middle Initial & Last Name & Degree
Jamshid Salamzadeh, PhD
First Name & Middle Initial & Last Name & Degree
Mojtaba Salarifard, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
29322434
Citation
Nozari Y, Eshraghi A, Talasaz AH, Bahremand M, Salamzadeh J, Salarifar M, Pourhosseini H, Jalali A, Mortazavi SH. Protection from Reperfusion Injury with Intracoronary N-Acetylcysteine in Patients with STEMI Undergoing Primary Percutaneous Coronary Intervention in a Cardiac Tertiary Center. Am J Cardiovasc Drugs. 2018 Jun;18(3):213-221. doi: 10.1007/s40256-017-0258-8.
Results Reference
derived

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Effect of N-acetylcystein in Myocardial Infarction

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