Introduction and aim: stroke is third leading cause of death and is the most common disabling neurological disease. This complication is the main cause of serious and long-term disability in the United States. Financial and economic impact of stroke is very impressive and direct and indirect costs of this disease have caused that is was one of the greatest health challenges in the world. Purpose of this study was to investigate the effect of different doses of clopidogrel on the first day of treatment to reduce complications in patients with acute cerebral ischemic stroke.
Material and methods: this study confirmed by neurologic committee of Sina hospital. 50 patients within 24 hours of the occurrence of an acute neurologic deficit with diagnosis of acute cerebral ischemic stroke admitted to this hospital had been entered the study. Age of patients was 50-80 years old. Degree of neurologic deficit before taking the drug was determined by NIHSS Score. The case group received 300 mg clopidogrel and the control group received 75 mg clopidogrel and placebo 225 mg on the first day of treatment.75 mg clopidogrel was administered to both groups in the after days. The recovery status of Patients was assessed by the Modified Rankin Scale and Barthel Index after 2 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201407213106N18
Registration date:2015-03-05, 1393/12/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-05, 1393/12/14
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Pharmaceutical science branch of Islamic Azad University
Expected recruitment start date
2014-08-01, 1393/05/10
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clopidogrel loading dose with standard regime Acute Ischemic Stroke
Public title
Evaluation of different doses administration of clopidogrel in acute ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: the patient with acute ischemic stroke
above 40 and under 80 years old.
Exclusion criteria: hemorrhage; need to anticoagolant or heparin; platelet decrease.
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Pharmaceutical science branch of Islamic Azad University
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Postal code
Approval date
2012-06-20, 1391/03/31
Ethics committee reference number
3335
Health conditions studied
1
Description of health condition studied
Acute ischemic stroke
ICD-10 code
G46.3
ICD-10 code description
Brain stem stroke syndrome
Primary outcomes
1
Description
Aphasia and dysmotility
Timepoint
at the end 2 weeks
Method of measurement
NIHSS Score
Secondary outcomes
1
Description
Unablility to move
Timepoint
At the of 2nd week
Method of measurement
Barthel index and Modified rankin scale
Intervention groups
1
Description
Intervention group: recivied 300 mg clopidogrel at the first day.
Category
Treatment - Drugs
2
Description
Control group:recivied 75 mg clopidogrel and 225 mg placebo at the first day.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Mohamadreza Gheini
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pharmaceutical science branch of Islamic Azad University
Full name of responsible person
Dr Sepide Arbabi Bidgoli
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmaceutical science branch of Islamic Azad University
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pharmaceutical science branch of Islamic Azad university
Full name of responsible person
Dr. Farshad Hashemian
Position
Associate professor
Other areas of specialty/work
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Postal code
Phone
+98 21 2264 0056
Fax
Email
hashemian.f@iaups.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)