Effect of N-acetylcystein in Myocardial Infarction
Evaluation of N-acetylcystein on Biomarkers of Platelet Activation , Cardiac Necrosis and Coronary Reperfusion in Patients Undergoing Percutaneous Coronary Intervention
2 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Posted
Study publicly available on registry
December 4, 2012
CompletedDecember 4, 2012
November 1, 2012
1.9 years
November 30, 2012
November 30, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Biomarkers of platelet activation (P selectin- CD40L-IL[Interleukin] 10- TGF[Transforming Growth Factor]-beta)
Change from the baseline after 24 hours
Secondary Outcomes (3)
Cardiac Necrosis Biomarkers (CKMB, Troponin T)
Change from the baseline after 12 hours
score of coronary blood flow(TIMI flow and MBG)
Change from the baseline after percutaneous coronary intervention
MACE (Major Adverse Cardiac Effect)
30 days
Study Arms (2)
control
NO INTERVENTIONcontrol This group is without N-acetylcystein : just receives standard treatment
N-acetylcystein
ACTIVE COMPARATORreceive N-acetylcystein in addition to standard treatment Ampoule 200 mg/ml
Interventions
Active Comparator: N-acetylcystein receive N-acetylcystein in addition to standard treatment
Eligibility Criteria
You may qualify if:
- Myocardial infarction patients who were candidate of primary PCI
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Teran Heart Center
Tehran, Tehran Province, 1711713138, Iran
Related Publications (1)
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.
PMID: 29322434DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Azita Hajhossein Talasaz, PharmD,BCPS
Tehran University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2012
First Posted
December 4, 2012
Study Start
January 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
December 4, 2012
Record last verified: 2012-11