Protocol summary

Summary
Main objective: Comparing effectiveness of high dose atorvastatin versus low dose atorvastatin in cardiovascular outcome after percutaneous coronary intervention (PCI) in patients with stable angina, for prevention of major cardiovascular events- Method: randomized clinical trial, double blinded, single center, drug intervention- Control group: atorvastatin, tablet 10 mg twice per day oral (standard treatment)- Intervention group: atorvastatin, tablet 40 mg twice per day oral- Inclusion criteria: patients with stable angina that nominated for coronary angioplasty- Exclusion criteria: acute coronary syndrome (unstable angina, non ST elevation myocardial infarction, ST elevation myocardial infarction), bare stent angioplasty, balloon angioplasty, angioplasty on saphenous vein graft, liver disease- Volume: 469 patients, 6 month fallow up- Primary outcome measure: major adverse cardiac and cerebrovascular events, all cause mortality, stroke, target lesion revascularization, target vessel revascularization, acute coronary syndrome, at least 3 times increase of liver and or mascular enzymes- Secondary outcome measure: total cholesterol (end of study), LDL (end of study), HDL (end of study), triglyceride(end of study), total cholesterol to HDL (end of study)

General information

Acronym
HAT-COP
IRCT registration information
IRCT registration number: IRCT2016060418741N2
Registration date: 2016-06-14, 1395/03/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-06-14, 1395/03/25
Registrant information
Name
Babak Bagheri
Name of organization / entity
Mazandaran university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3332 4002
Email address
bbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran Univesity of Medical Sceinces
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effectiveness of high dose atorvastatin versus low dose atorvastatin in cardiovascular outcome after Percutaneous Coronary Intervention (PCI) in patients with stable angina
Public title
effect of high dose of atorvastatin after angioplasty in patients with stable angina
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with stable angina that nominated for coronary angioplasty Exclusion criteria: acute coronary syndrome (unstable angina, non ST elevation myocardial infarction, ST elevation myocardial infarction); bare stent angioplasty; balloon angioplasty; angioplasty on saphenous vein graft; liver disease
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 469
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
Mazandaran University of Medical Sciences
Street address
Valiasr highway, Imam square, Sari
City
Sari
Postal code
Approval date
2013-01-23, 1391/11/04
Ethics committee reference number
91168

Health conditions studied

1

Description of health condition studied
stable angina
ICD-10 code
I25
ICD-10 code description
Chronic ischaemic heart disease

Primary outcomes

1

Description
major adverse cardiovascular and cerebrovascular events
Timepoint
6 month after procedure
Method of measurement
Questionnaire

2

Description
all cause mortality
Timepoint
6 month after procedure
Method of measurement
Questionnaire

3

Description
myocardial infarction
Timepoint
6 month after procedure
Method of measurement
Questionnaire

4

Description
stroke
Timepoint
6 month after procedure
Method of measurement
Questionnaire

5

Description
target lesion revascularization
Timepoint
6 month after procedure
Method of measurement
Questionnaire

6

Description
target vessel revascularization
Timepoint
6 month after procedure
Method of measurement
Questionnaire

7

Description
acute coronary syndrome
Timepoint
6 month after procedure
Method of measurement
Questionnaire

8

Description
at least 3 times increase of liver enzyme
Timepoint
3 , 6 month after procedure
Method of measurement
miligram per deciliter

9

Description
at least 3 times increase of mascular enzyme
Timepoint
3 , 6 month after procedure
Method of measurement
miligram per deciliter

Secondary outcomes

1

Description
low density lipoprotein (LDL)
Timepoint
end of study
Method of measurement
miligram per deciliter

2

Description
total cholesterol
Timepoint
end of study
Method of measurement
miligram per deciliter

3

Description
high density lipoprotein (HDL)
Timepoint
end of study
Method of measurement
miligram per deciliter

4

Description
triglyceride
Timepoint
end of study
Method of measurement
miligram per deciliter

5

Description
total cholesterol to HDL
Timepoint
end of study
Method of measurement
miligram per deciliter

Intervention groups

1

Description
Intervention group: atorvastatin- tablet 40 mg twice per day up to 6 month
Category
Treatment - Drugs

2

Description
Control group: standard treatment- atorvastatin- tablet 10 mg twice per day up to 6 month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital of Fatemeh Zahra
Full name of responsible person
Tohid Rahimi
Street address
Artesh boulevard, Sari
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Valiasr high way,Imam square, Sari
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Tohid Rahimi
Position
resident of cardiology
Other areas of specialty/work
Street address
Valiasr high way, Imam square, Sari
City
Sari
Postal code
Phone
+98 11 3332 4002
Fax
Email
t.rahimi59@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hospital of Fatemeh Zahra
Full name of responsible person
Tohid Rahim
Position
resident of cardiology
Other areas of specialty/work
Street address
Artesh boulevard, Sari
City
Sari
Postal code
Phone
+98 11 3332 4002
Fax
Email
t.rahimi59@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hospital of Fatemeh Zahra
Full name of responsible person
Tohid Rahimi
Position
resident of cardiology
Other areas of specialty/work
Street address
Artesh boulevard, Sari
City
Sari
Postal code
Phone
+98 11 3332 4002
Fax
Email
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
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