comparison of efficacy and safety of high-dose versus low-dose aspirin in patients with ST-segment myocardial infarction (STEMI) after primary percutaneous coronary intervention
objective: The aim of this study is to compare long term safety and efficacy of low-dose versus high-dose aspirin in patients with ST segment elevation myocardial infarction (STEMI)undergoing primary percutaneous coronary intervention (PCI). design: This is a double-blind parallel randomized clinical trial. setting and conduct: this study perform at Heshmat hospital, Rasht, Iran. participants: patients with STEMI defined as typical chest pain lasting for >30 minutes and ST-segment elevation >1 mm in >2 contiguous electrocardiographic leads, who underwent primary PCI within 12 hours of the onset of symptoms include to the study. Patients with a history of gastrointestinal bleeding and hemorrhagic stroke exclude from the study. An informed consent will be provided for all patients to participate. intervention: Eligible patients then randomly allocate to receive 325 mg daily as high-dose aspirin or 81 mg daily as low-dose aspirin for one month. Drugs will be provided in similar boxes labeled as A or B. main outcome variables: death, myocardial infarction, revascularization procedure stroke and major bleeding during one year after primary PCI.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014122220392N1
Registration date:2016-02-28, 1394/12/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-28, 1394/12/09
Registrant information
Name
Fatemeh Moaddab
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3361 8177
Email address
moaddab@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan University of Medical Sciences.
Address: vice chancellor for research building, west Shahid Beheshti highway, Rasht, Iran
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of efficacy and safety of high-dose versus low-dose aspirin in patients with ST-segment myocardial infarction (STEMI) after primary percutaneous coronary intervention
Public title
efficacy and safety of various aspirin doses in patients with ST-segment myocardial infarction undergoing primary percutaneous coronary intervention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with ST-segment myocardial infarction who underwent primary PCI within 12 hours of the onset of heart attack.
Exclusion Criteria:patients with a history of gastrointestinal bleeding and hemorrhagic stroke; opium and alcohol abusers, patients with coagulopathies or history of anticoagulant therapy ; major surgery within 6 weeks; platelets less than 100,000/ microliter; hematocrit less than 25%; creatinine more than 4 mg/dl
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
175
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Guilan University of Medical Sciences
Street address
Vice chancellor for research building, West Shahid Beheshti highway, Rasht, Iran
telephone interview and echcardiogarphy for patients with primary outcome
Secondary outcomes
1
Description
Major bleeding
Timepoint
one month and one year after primary PCI
Method of measurement
telephone interview
Intervention groups
1
Description
The intervention group receive aspirin with chemical substance of acetyl salisilic acid as 325 mg orally tablet once a day for a duration of 1 month from days 2-30 after primary PCI.
Category
Treatment - Drugs
2
Description
The control group receive aspirin with chemical substance of acetyl salisilic acid as 80 mg orally tablet once a day for a duration of 1 month from days 2-30 after primary PCI.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmat Hospital
Full name of responsible person
Dr. Pursadeghi
Street address
Heshmat Hospital, 15 khordad street, Rasht
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Guilan University of Medical Sciences
Full name of responsible person
Dr. Rasoul Tabari
Street address
vice chancellor for research building, west Shahid Beheshti highway, Rasht, Iran
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Guilan 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
Guilan university of medical sciences
Full name of responsible person
Dr. Mohaddese Pursadeghi
Position
Resident of Cardiology
Other areas of specialty/work
Street address
interventional cardiovascular research center, Heshmat hospital, 15 Khordad st, Rasht, Iran
City
Rasht
Postal code
Phone
+98 13 3361 8177
Fax
Email
saman.khojasteh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan university of medical sciences
Full name of responsible person
Dr. Arsalan Salari
Position
Cardiologist and Angioplasty Fellowship
Other areas of specialty/work
Street address
interventional cardiovascular research center, Heshmat hospital, 15 Khordad st, Rasht, Iran
City
Rasht
Postal code
Phone
+98 13 3361 8177
Fax
Email
a.salari55@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan university of medical sciences
Full name of responsible person
Dr. Mohadese Pursadeghi
Position
Reident of Cardiology
Other areas of specialty/work
Street address
interventional cardiovascular research center, Heshmat hospital, 15 Khordad st, Rasht, Iran
City
Rasht
Postal code
Phone
+98 13 3361 8177
Fax
Email
sasan.khojasteh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)