Protocol summary

Summary
The design objective of this study was to evaluate the effect of Helicobacter pylori eradication in reducing gastrointestinal bleeding in patients under treatment with aspirin and clopidogrel. Inclusion criteria included patients receiving the theraputic regimen of aspirin and clopidogrel in acute coronary syndrome and positive Helicobacter pylori stool antigen test. Exclusion criteria included a history of gastrointestinal bleeding, history of Helicobacter pylori eradication, pregnancy, cirrhosis, Patients with any medical history of any malignancy, history of peptic disease proven by endoscopy, acute or chronic renal failure, decompensated heart failure, and other serious health conditions. After the initial assessment, one hundred and forty patients were randomly divided into treatment and control groups. The two groups are matched in terms of factors such as age, sex, underlying disease (diabetes, hypertension), type of acute coronary syndrome, history of aggressive medical intervention (coronary stenting with balloon angioplasty), smoking and corticosteroid consumption. Patients in the control group received only pantoprazole and placebo while treatment group, received Standard Triple-Drug Therapy for Helicobacter pylori Eradication including amoxicillin, clarithromycin and pantoprazole over ten days. After 4 weeks of eradication therapy by stool antigen test, patients in the treatment group are examined. Once eradication is confirmed, Patients will be assessed quarterly for gastrointestinal bleeding. Deaths due to cardiovascular events or gastrointestinal complications are recorded. After three months, patients of both groups are compared. The primary objective was to reduce gross gastrointestinal bleeding and decreasing gastrointestinal symptoms such as dyspepsia, heart failure or recurrent thrombotic events during the study period were selected as secondary targets.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014081814190N5
Registration date: 2014-09-06, 1393/06/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-09-06, 1393/06/15
Registrant information
Name
Mohammad Bahadoram
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3011
Email address
bahadoram.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology Development-Ahvaz Jondishapur University of Medical Sci
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of helicobacter pylori eradication in Gastrointestinal side effects of aspirin and clopidogrel in patients with acute coronary syndrome
Public title
Efficacy of helicobacter pylori eradication in Gastrointestinal side effects in patients with acute coronary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients receiving the therapeutic regimen of aspirin and clopidogrel in acute coronary syndrome; positive Helicobacter pylori stool antigen test. Exclusion criteria: history of gastrointestinal bleeding; history of Helicobacter pylori eradication; pregnancy; cirrhosis; Patients with any medical history of any malignancy; history of peptic disease proven by endoscopy; acute or chronic renal failure; decompensated heart failure; other serious health conditions.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
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
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, University City, Ahvaz
City
Ahvaz
Postal code
Approval date
2013-08-23, 1392/06/01
Ethics committee reference number
ajums.REC.1393.38

Health conditions studied

1

Description of health condition studied
Acute coronary syndrome
ICD-10 code
I24.9
ICD-10 code description
Acute ischaemic heart disease, unspecified

Primary outcomes

1

Description
gross gastrointestinal bleeding
Timepoint
Three months after the end of treatment
Method of measurement
using a questionnaire

Secondary outcomes

1

Description
Dyspepsia
Timepoint
Three months after the end of treatment
Method of measurement
using a questionnaire

2

Description
Thrombotic events
Timepoint
Three months after the end of treatment
Method of measurement
using a questionnaire

Intervention groups

1

Description
Intervention group: Amoxicillin 1 gram twice daily + Clarithromycine 500 mg twice daily + Pantoprazol 40 mg twice daily + Garlic daily
Category
Treatment - Drugs

2

Description
Control group: Patients received Pelasebo + Pantoprazol 40 mg twice daily.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Hospital
Full name of responsible person
Dr. Abdol Rahim Masjedizadeh
Street address
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology Development-Ahvaz Jondishapur University of Medical Sci
Full name of responsible person
Dr. Nader Saki
Street address
Ground Floor, Faculty of Rehabilitation Sciences ,Ahvaz Jundishapur University of Medical Sciences, Ahvaz
City
Ahvaz
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 and Technology Development-Ahvaz Jondishapur University of Medical Sci
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Arman Shahriari
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, University City, Ahvaz Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1336 7543
Fax
Email
armanshahriari@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Abdol Rahim Masjedizadeh
Position
Association professor at Gastroenterology and Endoscopy
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, University City, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1336 7543
Fax
Email
rahim.masjedi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mohammad Bahadoram
Position
Medical Student
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, University City, Ahvaz
City
Ahvaz
Postal code
Phone
00
Fax
Email
mohammadbahadoram@yahoo.com; bahadoram.m@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...