Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2011-01-31
2012-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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control
control This group is without N-acetylcystein : just receives standard treatment
No interventions assigned to this group
N-acetylcystein
receive N-acetylcystein in addition to standard treatment Ampoule 200 mg/ml
N-acetylcystein
Active Comparator: N-acetylcystein receive N-acetylcystein in addition to standard treatment
Interventions
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N-acetylcystein
Active Comparator: N-acetylcystein receive N-acetylcystein in addition to standard treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Tehran University of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Azita Hajhossein Talasaz, PharmD,BCPS
Role: PRINCIPAL_INVESTIGATOR
Tehran University of Medical Sciences
Locations
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Teran Heart Center
Tehran, Tehran Province, Iran
Countries
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Facility Contacts
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Azita Hajhossein Talasaz
Role: primary
References
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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.
Other Identifiers
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IRCT201210118698N2
Identifier Type: REGISTRY
Identifier Source: secondary_id
524
Identifier Type: -
Identifier Source: org_study_id