We designed this study to evaluate 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) are selected. Patients have Myocardial infarction included. Patients were excluded if had: emergency for cardiac bypass ,cardiogenic shock , treatment with glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention and rescue percutaneous coronary intervention . The patients in Intervention group were adminitered to take 100 mg/kg Iv bolus N-acetylcystein and then 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. Patients were assessed for coronary blood flow after percutaneous coronary intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201210118698N2
Registration date:2012-11-02, 1391/08/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-02, 1391/08/12
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
Tehran University of Medical Sciences
Expected recruitment start date
2011-01-21, 1389/11/01
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of N-acetylcystein on biomarkers of platelet activation and coronary reperfusion in patients undergoing percutaneous coronary intervention
Public title
Effect of N-acetylcystein in myocardial infarction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria:Myocardial infarction patients who were candidate of primary PCI .
Exclusion Criteria:rescue pci;
emergency for cardiac bypass ;
cardiogenic shock;
life expactancy less than 6 months;
Age less than 18 years old;
Uncontrolled hypertension;
Thrombocytopenia;
Malformation or aneurysm;
sever chronic renal failure;
Sever liver failure;
treatment with glycoprotein IIb/IIIa inhibitors during PCI ;
sensitivity to sulfonamides ;
Major surjery;
Unsatisfactory to enter to study
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran heart center
Street address
North karegar-jalaaal alle ahmad avenue
City
tehran
Postal code
1411713138
Approval date
2011-12-13, 1390/09/22
Ethics committee reference number
268
Health conditions studied
1
Description of health condition studied
Myocardial Infarction
ICD-10 code
121
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
IL-10 biomarker of stenosis
Timepoint
after intervention
Method of measurement
Serum concentration ng/ml
2
Description
TGF-β biomarker of stenosis
Timepoint
after intervention
Method of measurement
serum concentration ng/ml
3
Description
CD40L biomarker of restenosis
Timepoint
after intervention
Method of measurement
serum concentration ng/ml
4
Description
P-selectin biomarker of restenosis
Timepoint
After intervention
Method of measurement
serum concentration ng/ml
Secondary outcomes
1
Description
TIMI a score of coronary blood flow
Timepoint
after intervention
Method of measurement
number
2
Description
MBG a score of coronary blood flow
Timepoint
after intervention
Method of measurement
number
3
Description
MACE
Timepoint
30-daye after intervention
Method of measurement
observation
4
Description
Added at 2014-08-03: Major Adverse cardiac events
Timepoint
Added at 2014-08-03: 30 days and 2 years
Method of measurement
Added at 2014-08-03: call to patient
Intervention groups
1
Description
The patients in Intervention group were adminitered to take 100 mg/kg Iv bolus N-acetylcystein and then intracoronary and 10mg/kg/h over 12 hours after percutaneous coronary intervention
Category
Treatment - Drugs
2
Description
Standard regimen for Primary percutaneous coronary intervention (Heparin,Clopidogerel ,ASA )
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran heart center
Full name of responsible person
Dr.Talaasaz
Street address
North karegar-jalaal ale ahmad avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mr. Jafari
Street address
Tehran University of Medical Sciences
City
tehran
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran Heart Center, Shaheed Beheshti University of Medical Sciences
Full name of responsible person
Azita Hajhossein Talasaz, Jamshid Salamzadeh
Position
Assistant professor, Associated professor
Other areas of specialty/work
Street address
Tehran Heart Center, Shaheed Beheshti University of Medical Sciences
City
Tehran
Postal code
Phone
+98 912 377 8707
Fax
Email
atalasaz@razi.tums.ac.ir, j.salamzadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Heart Center, Shaheed Beheshti University of Medical Sciences
Full name of responsible person
Azita Hajhossein Talasaz, Jamshid Salamzadeh
Position
assistant, associated
Other areas of specialty/work
Street address
Jalaal ale ahmad, North karegar
City
tehran
Postal code
1411713138
Phone
+91 23778707
Fax
Email
atalasaz@razi.tums.ac.ir, j.salamzadeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shaheed Beheshti University of Medical Sciences
Full name of responsible person
Azadeh Eshraghi
Position
Resident of clinical pharmacy
Other areas of specialty/work
Street address
Niayesh, Valeeasr Avenue
City
Tehran
Postal code
141556153
Phone
+98 913 315 2584
Fax
Email
aepharm@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)