Comparing the effect of Loading Doses of Clopidogrel and Prasugrel on the incidence of myocardial injury in the Candidates for Elective Percutaneous Coronary Intervention
Prevention of myocardial injury is an essential issue in percutaneous coronary intervention (PCI). We aim to compare the incidence of myocardial injury after loading doses of clopidogrel versus prasugrel in the candidates for elective PCI.
In this randomized-controlled clinical trial, we enrol 90patients with stable angina who arecandidate for elective PCI. Patients will be dedicated into 2 groups te receive either Prasugrel (60 mg P.O. stat) or Plavix (600 mg P.O. stat). Serum levels of CK-MB, cardiac troponin I (cTNI) and high sensitive C - reactive protein (hs-CRP) will be measured at baseline and 6 and 12 hours post-procedural. Primary endpoint are periprocedural MI, defined as elevation of cTn values (>5 times) in patients with normal baseline values or a rise of cTn values >20% if the baseline values are elevated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201408069768N3
Registration date:2014-08-19, 1393/05/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-19, 1393/05/28
Registrant information
Name
Akbar Shafiee
Name of organization / entity
Tehran Heart Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9256
Email address
shafiee@leydenacademy.nl
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-01-01, 1391/10/12
Expected recruitment end date
2014-01-01, 1392/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Loading Doses of Clopidogrel and Prasugrel on the incidence of myocardial injury in the Candidates for Elective Percutaneous Coronary Intervention
Public title
Comparing the effect of Loading Doses of Clopidogrel and Prasugrel on the incidence of myocardial injury in the Candidates for Elective Percutaneous Coronary Intervention
Purpose
Treatment
Inclusion/Exclusion criteria
we enrolled patients with stable angina who were candidate for elective PCI and gave informed consent to take part in this trial. The exclusion criteria included: history of coronary artery bypass graft surgery; need for emergency PCI (in less than 2 hours); history of renal dysfunction; any contraindication for prasugrel or Plavix; body weight<60 kg; age≥75 years; history of cerebrovascular accident and transient ischemic attack, serum creatinine>1.5mg/dl; and ejection fraction<30%.
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Imam Khomeini Hospital
Street address
Keshavarz Blvd, Dr. Gharib st
City
Tehran
Postal code
Approval date
2011-11-20, 1390/08/29
Ethics committee reference number
4912-90-10
Health conditions studied
1
Description of health condition studied
Subsequent myocardial infarction
ICD-10 code
I22
ICD-10 code description
For morbidity coding, this category should be assigned for infarction of any myocardial site, occurring within 4 weeks (28 days) from onset of a previous infarction
Primary outcomes
1
Description
periprocedural myocardial infarction
Timepoint
elevation of cTn values (>5 times) in patients with normal baseline values or a rise of cTn values >20% if the baseline values are elevated
Method of measurement
Blood survey
Secondary outcomes
empty
Intervention groups
1
Description
Prasugrel (60 mg P.O. stat)
Category
Treatment - Drugs
2
Description
Plavix (600 mg P.O. stat)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
imam Khomeini Hospital
Full name of responsible person
Reza Rahmani
Street address
Keshavarz Blvd, Dr. Gharib st
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Rahmani
Street address
Keshavarz blvd, dr Gharib st
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
Full name of responsible person
Akbar Shafiee
Position
Md, MSc
Other areas of specialty/work
Street address
North Kargar st.
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
Email
leo71538@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Khomeini Hospital
Full name of responsible person
Reza Rahmani
Position
MD
Other areas of specialty/work
Street address
Keshavarz Blvd, Dr Gharib st
City
Tehran
Postal code
1411713138
Phone
+98 21 6119 2647
Fax
Email
r_rahmani@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Akbar Shafiee
Position
Other areas of specialty/work
Street address
North Kargar st.
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
Email
leo71538@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)