The purpose of this study is to compare the effect of Aspirin and Warfarin in preventing the recurrence of ischemic stroke in patients who have high risk patent foramen ovale (PFO); according to contrast-trans cranial doppler sonography findings. High risk PFO is defined as: 1. Accompany with atrial septal aneurysm 2. More than 50 bubbles observe during contrast-echocardiography 3. Multiple territory infarcts 4. Infarction following valsalva maneuver. All patients with ischemic stroke and PFO with above criteria will be included in this study. It was predicted that 35 patients will be recruited. Patients undergo contrast Trans-cranial doppler sonography and number of Micro-Embolic Signals (MES) will be counted. Then subjects will be divided in two groups blindly to receive Warfarin or Aspirin. They will be followed for 12 months for recurrence of stroke or complication of the managements. At the end of the study the preventive effect of Warfarin and Aspirin would be compared.
General information
Acronym
AWHPFO
IRCT registration information
IRCT registration number:IRCT138805192323N1
Registration date:2009-11-21, 1388/08/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-11-21, 1388/08/30
Registrant information
Name
Ehsan Yaghoubi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1229 6076
Email address
yaghubie@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2008-10-31, 1387/08/10
Expected recruitment end date
2010-07-22, 1389/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of Aspirin and Warfarin in Prevention of Recurrence of Ischemic Stroke in Patients With High Risk Patent Foramen Ovale
Public title
Treatment of High Risk Patent Foramen Ovale According to Contrast-trans Cranial Doppler Sonography
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: permanent or transient cerebral or retinal ischemia, age more than 18 years old, more than 50 bubbles in echocardiography, presence of atrial septal aneurysm, multiple infarctions in brain CT
Exclusion criteria: more than 50% stenosis in colour doppler sonography of neck arteries, thrombosis or ulcerated plaques in neck arteries, other cardiac definite source of stroke
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mohamad Hossein Dabaghmanesh
Street address
Main University building, division of research
City
Shiraz
Postal code
Approval date
2009-10-07, 1388/07/15
Ethics committee reference number
CT-88-4639
Health conditions studied
1
Description of health condition studied
permanent or transient cerebral or retinal ischemic attack
ICD-10 code
G45-G46
ICD-10 code description
Transient Cerebral Ischaemic attacks and related syndromes-Vascular syndromes of Brain in Cerebrovascular Diseases
Primary outcomes
1
Description
permanent or transient cerebral or retinal ischemic attack or death due to any cause
Timepoint
3 months, 6 months, 9 months and 12 months after intervention
Method of measurement
by phone for recurrence of stroke
Secondary outcomes
empty
Intervention groups
1
Description
Aspirin 80 mg TID orally and continuing for 1 year until progression or unacceptable toxicity develops.
Category
Treatment - Drugs
2
Description
Warfarin 5 mg per day orally and adjust it to achieve INR between 2 and 3 and continue it for 1 year until progression or unacceptable toxicity develops
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Reza Nemati
Street address
Namazi hospital, Zand square.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abdolhamid Shariat
Street address
Zand street, Main University Building, division of research
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Shiraz Neuroscience Research center, Shiraz University of Medical Sciences,
Full name of responsible person
Abdolhamid Shariat
Position
Assistant Professor of Neurology
Other areas of specialty/work
Street address
Zand square, Motahari Clinic, Neurology Department
City
Shiraz
Postal code
Phone
+98 71 1612 1065
Fax
Email
shariat123@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Afshin Borhani Haghighi
Position
Associate professor of Neurology
Other areas of specialty/work
Street address
Department of Neurology, motahari clinic, Zand square.
City
Shiraz
Postal code
Phone
+98 71 1612 1065
Fax
Email
borhanihaghighi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ehsan Yaghoubi
Position
Neurology resident
Other areas of specialty/work
Street address
Zand square, Namazi hospital
City
Shiraz
Postal code
Phone
+98 71 1612 1065
Fax
Email
yaghoubie@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)