The aim of this study is to evaluate the efficacy of Plavix versus Clopidex in Post stroke patients with Ischemic heart disease. After definite diagnosis of both diseases (ischemic stroke & coronary heart disease) and qualifying for inclusion in this study, the patients were randomly placed in two groups. Patients with contraindications of using anticoagulants will be excluded. finally two groups of 60 cases will be included. The first group will be given Clopidex tablets made in Exir Pharmaceutical Company and the second group will be given foreign made Palvix (75mg/d) for one month. Clinical and demographic characteristics assessment, biochemical blood tests (Complete Blood Count, Fasting Blood Sugar, Cholesterol, Triglyceride) and aggregometry tests will be done before and after treatment.
[Inclusion criteria]: Patients with Ischemic Heart Disease or ischemia; Patients consent for taking part in study; Patient cooperation in experiment pursuit and taking drugs; Patients shouldn’t be participating in any other clinical trial; Not having any drug taking record in the last month.
[Exclusion criteria]: Existence of any hemorrhagic diseases, for instance peptic ulcer and inner-cranial hemorrhage; Existence of accompanied diseases interfering with drugs taken; Any record of allergy to Palvix or Clopidex; Any contraindications for taking Palvix or Clopidex. (Thrombocytopenia, liver disorders, Neutropenia-…); Those of patients who needed some mechanical hemodynamic support like using balloon pump; age more than 85 years and under 18 years.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011025073N1
Registration date:2012-12-23, 1391/10/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-23, 1391/10/03
Registrant information
Name
Majid Shohrati
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
shohrati@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Mollasadra St, Vanak Sq, Tehran, Iran.
Expected recruitment start date
2012-08-01, 1391/05/11
Expected recruitment end date
2013-08-01, 1392/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the efficacy of Plavix and Clopidex in Post stroke patients with Ischemic heart disease
Public title
The efficacy of Palvix and Clopidex in Post-Stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
[Inclusion criteria]: Patients with Ischemic Heart Disease or ischemia; Patients consent for taking part in study; Patient cooperation in experiment pursuit and taking drugs; Patients shouldn’t be participating in any other clinical trial; Not having any drug taking record in the last month,
[Exclusion criteria]: Existence of any hemorrhagic diseases, for instance peptic ulcer and inner-cranial hemorrhage; Existence of accompanied diseases interfering with drugs taken; Any record of allergy to Palvix or Clopidex; Any contraindications for taking Palvix or Clopidex. (Thrombocytopenia, liver disorders, Neutropenia-…); Those of patients who needed some mechanical hemodynamic support like using balloon pump; age more than 85 years and under 18 years.
Age
From 18 years old to 85 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Sciences, Tehran
Street address
Mollasadra St, Vanak Sq,
City
Tehran
Postal code
Approval date
2011-02-19, 1389/11/30
Ethics committee reference number
س/340/2/5347
Health conditions studied
1
Description of health condition studied
ischemic cerebrovascular stroke
ICD-10 code
I63.4
ICD-10 code description
Cerebral infarction due to embolism of cerebral arteries
Primary outcomes
1
Description
coagulation profile
Timepoint
baseline and one month later
Method of measurement
using platelet count, bleeding time and coagulation time
Secondary outcomes
1
Description
platelet aggrigation
Timepoint
baseline and one month later
Method of measurement
aggrigometery test
Intervention groups
1
Description
Tablet Iranian Clopidegrol made by Exir Co. 75 mg daily for 1 month as the case group, one per day
Category
Treatment - Drugs
2
Description
Tablet Plavix (75 mg) per os (orally) daily were used for control group for one month, one per day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatall University Hospital
Full name of responsible person
Dr Majid Shohrati, Dr Maryam Moshkani
Street address
Mollasadra st, Vanak Sq,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Majid Shohrati
Street address
Mollasadra st, Vanak sq
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah 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
Baqiayatallah University of Medical Sciences, Chemial Injuries Research Center
Full name of responsible person
Dr Majid Shohrati
Position
Asocciate professor
Other areas of specialty/work
Street address
Mollasadra st, Vanak sq
City
Tehran
Postal code
Phone
+98 21 8860 0067
Fax
Email
shohratimajid@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Majid Shohrati
Position
Asocciate Professor
Other areas of specialty/work
Street address
Mollasadra st, Vavak Sq
City
Tehran
Postal code
Phone
+98 21 8860 0067
Fax
Email
shohratimajid@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiayatallah University of Medical Sciences, Tehran, Iran.
Full name of responsible person
Dr Majid Shohrati
Position
Associate Professor
Other areas of specialty/work
Street address
Mollasadra st, Vanak sq
City
Tehran
Postal code
Phone
+98 21 8860 0067
Fax
Email
shohratimajid@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)