This is a double blind, placebo controlled, parallel designed randomized clinical trial on 370 subjects referred to clinical offices in Broujerd city.The volunteer subjects are divided into five groups based on consumption of different doses of aspirin. Written informed consent will be obtained from the patients and their medical history is recorded according to a designed questionnaire. Inclusion criteria: All subjects age 35 and older Exclusion criteria comprise of past medical history of congenital or acquired coagulation disorders , renal failure,blood cell dyscrasia, use of medications affecting blood cells, platelets less than 150000, simultaneous use of other anti platelets and anticoagulants like warfarin and previous history of hypersensitivity to aspirin. Patients are divided into four testing groups :testing group 1 (ASA 80 mg per day) ,testing group 2 (ASA 81 mg per day), testing group 3 (ASA100 mg per day),testing group 4 (ASA 325 mg per day) and one control group of placebo.Thereafter the participants Bleeding time will be tested using Ivy method and urinary Thromboxane B2.since the technique is painful this test will be performed just once for each participant after using aspirin . In case of different interpretation of the results of one participant, the mean of the results will be considered. Participants will be tested for other tests which affect bleeding time and blood group will also be tested. Aspirin resistance is defined as no increment of bleeding time more than normal upper limit of bleeding time.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202026958N3
Registration date:2012-06-07, 1391/03/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-06-07, 1391/03/18
Registrant information
Name
Ali Maleki
Name of organization / entity
Lorestan university of medical siences
Country
Iran (Islamic Republic of)
Phone
+98 66 2353 8057
Email address
maleki.a@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences
Expected recruitment start date
2012-07-01, 1391/04/11
Expected recruitment end date
2013-01-30, 1391/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of aspirin resistance in different doses of ASA by bleeding time
Public title
Evaluation of aspirin resistance in different doses of aspirin
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: All participants 35 years old and older , who are living in Borujerd city.Participants should have used ASA at least for 5 days.
Exclusion criteria: History of acquired or congenital coagulation disorders ,chronic kidney diseases and blood discrasia were excluded from the study. Consumption of some medications such as other platelet inhibitors and anticoagulants such as warfarin ; and volunteers with platelet count less than 150000.
Age
From 35 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
370
Randomization (investigator's opinion)
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
Lorestan University of Medical Sienceses
Street address
Kamalvand Research Center
City
Khoramabad
Postal code
Approval date
2012-01-31, 1390/11/11
Ethics committee reference number
200/61140
Health conditions studied
1
Description of health condition studied
Aspirin resistance
ICD-10 code
Y45.1
ICD-10 code description
Salicylates
Primary outcomes
1
Description
Bleeding time and urinary thromboxane B2
Timepoint
Once , after intervention
Method of measurement
IVY method
2
Description
Thromboxane B2
Timepoint
Once after intervention
Method of measurement
Urinary sample
Secondary outcomes
empty
Intervention groups
1
Description
Testing group1: aspirin (80 mg) , 1 pill per day
Category
Diagnosis
2
Description
Testing group 2: aspirin (81mg), 1 pill per day
Category
Diagnosis
3
Description
Testing group3: aspirin (100 mg), 1 pill per day
Category
Diagnosis
4
Description
Testing group4: aspirin (325 mg), 1 pill per day
Category
Diagnosis
5
Description
Control group : placebo, 1 pill per day
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Maleki Office
Full name of responsible person
Dr Ali Maleki
Street address
N.11, Mehr Medical center
City
Broujerd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr Mohammadhassan Kaedi
Street address
Kamalvand, Research center
City
Khoramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?