Unfractioned heparin (UFH) is the standard antithrombotic agent in elective percutaneous coronary intervention (PCI), but it has its own limitations. Several mostly uncontrolled studies have suggested intravenous Enoxaparin as a safe and effective alternative. Our main goal was to evaluate the safety of Enoxaparin over UFH in elective PCI. We randomly assigned 195 patients undergoing PCI to receive 0.75 mg per kilogram of body weight Enoxaparin or 10000 IU unfractioned heparin. All patients also took oral Aspirin 325 mg/day and Clopidogrel 450 mg before the procedure. Patients were recommended remaining on Clopidigrel for at least 3 months. These two interventions was compared regarding prevention of thrombosis and bleeding complications.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138710101525N1
Registration date:2009-12-20, 1388/09/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-12-20, 1388/09/29
Registrant information
Name
Mohammad Javad Zibaeenezhad
Name of organization / entity
Cardiovascular Research Center, Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1234 3529
Email address
zibaeem2@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2004-10-31, 1383/08/10
Expected recruitment end date
2006-10-31, 1385/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Incidence of clinical sign and symptom of acute ischemia and vascular complication with Enoxaparin during stenting in comparison with heparin
Public title
Safety of Enoxaparin versus unfractioned heparin in patients undergoing percutaneous coronary intervention using drug eluting stents: A pilot study
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with atherosclerotic coronary artery disease (chronic stable angina or acute coronary syndromes) were included if they were candidate for PCI as a result of uncontrolled anginal pain, unresponsive to the maximum dose of nitrates or incidence of adverse drug reactions in which it was impossible to continue medical treatment, Patients with clinical sign of heart failure and ischemic involvement of a relatively large segment of myocardium
Exclusion criteria: Age 75 years or older, presence of renal failure defined as creatinine clearance of 30 ml/min and over,creatinine≥2.5 mg/dl in male and creatinine≥2.0 mg/dl in female participants, use of bare-metal stents, presence of primary PCI, receiving heparin or LMWH before randomization, unacceptable prothrombin time (PT) or platelet count, presence of platelet functional disorders or coagulopathies, or hypercoagulopathy syndromes.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand ave.
City
Shiraz
Postal code
Approval date
2008-08-18, 1387/05/28
Ethics committee reference number
CT-87-4188
Health conditions studied
1
Description of health condition studied
Coronary Artery Disease
ICD-10 code
I25
ICD-10 code description
Chronic ischaemic heart disease
Primary outcomes
1
Description
The incidence of major bleedings
Timepoint
during the first 24 hours following the index PCI
Method of measurement
Major bleeding was defined as clinically overt bleeding causing a decrease in hemoglobin ≥ 3 g/dl requiring transfusion of packed red cells or whole blood, bleedings which require surgical intervention to stop bleeding at the femoral sheath insertion site, intracranial bleeding, and retroperitoneal bleeding.
2
Description
The incidence of minor bleedings
Timepoint
During the first 24 hours following the index PCI
Method of measurement
by observation
Secondary outcomes
1
Description
The incidence of in-stent acute coronary thrombosis
Timepoint
during 24 hours after PCI
Method of measurement
by Observation
Intervention groups
1
Description
An intravenous bolus of 10000 IU unfractionated heparin, adjusted for activated clotting time according to current guidelines
Category
Prevention
2
Description
Intravenous Enoxaparin at a dose of 0.75 mg per kilogram during the procedure
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
cat-lab of Faghihi Hospital
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chanceller for Research Affairs, Shiraz University of Medical Sciences
Full name of responsible person
Vice-chanceller for Research Affairs, Shiraz University of Medical Sciences
Street address
7th Floor, Central Building of Shiraz University of Medical sciences, Zand ave., Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chanceller for Research Affairs, Shiraz 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
Cardiovascular Research Center, Shiraz University of Medical Sciences
Full name of responsible person
Zahra Daneshvar
Position
Research affairs expert
Other areas of specialty/work
Street address
Faghihi Hospital, Zand ave. Shiraz, Iran
City
Shiraz
Postal code
Phone
Fax
Email
zdaneshvar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Cardiovascular Research Center
Full name of responsible person
Mohammad Javad Zibaeenezhad
Position
Proffesor of Cardiology in Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Faghihi hospital, Zand ave. Shiraz, Iran
City
Shiraz
Postal code
Phone
Fax
Email
zibaeem2@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Cardiovascular Research Center
Full name of responsible person
Zahra Daneshvar
Position
Research affairs expert
Other areas of specialty/work
Street address
Faghihi Hospital, Zand Ave. Shiraz, Iran
City
Shiraz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)