The impact of allopurinol versus placebo in patients with acute ST-elevation myocardial infarction undergoing fibrinolytic therapy with streptokinase is studied. One hundred and forty-six patients with first acute ST-elevation myocardial infarction and unavailable primary per-cutaneous coronary intervention, who are candidates for fibrinolytic therapy will studied. Patients with previous myocardial infarction or primary valvular disease will excluded from the study. Patients will divided randomized (with Computer software "Random number generator"), double-blind (unaware patients and investigator) to placebo and allopurinol groups. In Allopurinol group, patients will receive four oral Allopurinol 100mg tablets stat when arriving at the emergency department, followed by one 100mg tablet daily for 4 weeks, other group will receive placebo. Then patients will be evaluated and compared for goals (90 minute ST resolution after fibrinolytic therapy, six months Major Adverse Cardiovascular Events (MACE), including in-hospital and late death, re-hospitalization for acute decompensation of heart failure, recurrent myocardial infarction and need to repeat revascularization).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014062916229N3
Registration date:2015-01-24, 1393/11/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-24, 1393/11/04
Registrant information
Name
Samad Ghaffari
Name of organization / entity
Cardiovascular Research Center, Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 3576
Email address
ghafaris@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Cardiovascular Research Center, Tabriz University of Medical SciencesDrug Applied Research Center, Tabriz University of Medical Sciences
Expected recruitment start date
2014-05-31, 1393/03/10
Expected recruitment end date
2015-05-31, 1394/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of allopurinol versus placebo in patients with acute ST elevation myocardial infarction undergoing fibrinolytic therapy with streptokinase
Public title
The impact of Allopurinol in acute myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with first acute STEMI who are candidates for fibrinolytic therapy
Exclusion criteria: Patients with firs acute STEMI who are candidates for Primary PCI, Patients with previous myocardial infarction or Primary valvular disease
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
146
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The trial is double blind, so neither the patients nor the investigator are aware of the type of administered drug (Allopurinol or placebo). Random drug list has been prepared by the governing board of the Center for Drug Research.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah St., Tabriz
City
Tabriz
Postal code
Approval date
2013-07-22, 1392/04/31
Ethics committee reference number
92178
Health conditions studied
1
Description of health condition studied
myocardial infarction
ICD-10 code
121.3
ICD-10 code description
Acute transmural myocardial infarction of unspecified site
Primary outcomes
1
Description
ST resolution (in milimeter)
Timepoint
On arriving at the emergency department (before the intervention) and 90 minute after streptokinase adminsteration(intervention) in emergency department
Method of measurement
ECG
Secondary outcomes
1
Description
Cardiac biomarkers level
Timepoint
first 48 hour (arrival at the emergency department (before the intervention) and then daily(after the intervention))
Method of measurement
laboratory
2
Description
Heart failure
Timepoint
During hospitalization
Method of measurement
Physical examination and history and echocardiography
3
Description
Recurrent myocardial infarction
Timepoint
six month after intrvention (streptokinase)
Method of measurement
Telephone follow-up and patients hospital records
4
Description
In hospital death
Timepoint
During hospitalization
Method of measurement
Physical examination
5
Description
six month death
Timepoint
six month after intrvention (streptokinase)
Method of measurement
Telephone follow-up and patients hospital records
6
Description
Re-hospitalization for acute decompensation of heart failure
Timepoint
six month after intrvention (streptokinase)
Method of measurement
Telephone follow-up and patients hospital records
7
Description
Repeat revascularization
Timepoint
six month after intrvention (streptokinase)
Method of measurement
Telephone follow-up and patients hospital records
Intervention groups
1
Description
Intervention 1: patients will receive four oral Allopurinol 100mg tablets when arriving at the emergency department, followed by one 100mg tablet daily for 4 weeks.
Allopurinol is a xanthine oxidase inhibitor and decreases production of uric acid.
Category
Treatment - Drugs
2
Description
Intervention 2: Placebo tablets are similar in appearance with Allopurinol tablets,which patients will receive four oral tablets when arriving at the emergency department, followed by one tablet daily orally for 4 weeks.
Allopurinol and Placebo tablets has prepared by Drug Applied Research Center of Tabriz University of Medical Sciences.