Efficacy and safety endpoints of Ranolazine in comparison with conventional therapy in reduction of HbA1c percentage in type 2 diabetic patients with ischemic heart disease
An useful trial to change the protocol of using Ranolazin consumption in diabetic patients with CAD
Design
Two arm parallel group randomized trial with none-blinded postoperative care and outcome assessment of 60 patients
Settings and conduct
Rajaie cardiovascular, medical and research center, Valiasr Avenue, Tehran, Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria: HbA1c more than 6.5%, Age more than 50 year, both genders with diabetes mellitus and CAD.
CSA at least 3 months triggered by physical effort and relieved by rest and/or sublingual nitroglycerin.
CAD documented by one or more of the following: Angiography evidence of more than 50% stenosis of one or more coronary arteries, History of MI, Cardiac imaging or exercise test diagnostic for CAD.
Treatment with up to 2 anti-anginal therapies at a stable dose for at least 2 weeks before starting the trial.
T2DM patients who use Metformin and Gliclazide.
Exclusion criteria: New York Heart Association Class III and IV.
Acute coronary syndrome in the prior 2 months or planned for coronary revascularization.
Stroke or transient ischemic attack within 6 months prior.
QTc more than 500 ms.
Systolic blood pressure more than 180, diastolic blood pressure more than 110 mmHg.
Liver cirrhosis.
Prior treatment with CYP 3A4 inhibitors or P GlyP inductors.
Treatment with anti arrhythmic medicine class ll and lll.
Alcohol consumption or drug users.
Simvastatin consumption.
Intervention groups
Control group who takes nitroglycerin and metformin and glyclazide and in other group ranolazine added and nitroclycerin consumption discontinued
Main outcome variables
Reduction of HbA1c
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161026030511N3
Registration date:2018-12-23, 1397/10/02
Registration timing:retrospective
Last update:2018-12-23, 1397/10/02
Update count:0
Registration date
2018-12-23, 1397/10/02
Registrant information
Name
bahram fariborz farsad
Name of organization / entity
Rajaei Cardiovascular, Medical & Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 22139
Email address
ffarsad@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Samin daroo company
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
2016-06-21, 1395/04/01
Actual recruitment end date
2016-12-21, 1395/10/01
Trial completion date
2017-02-23, 1395/12/05
Scientific title
Efficacy and safety endpoints of Ranolazine in comparison with conventional therapy in reduction of HbA1c percentage in type 2 diabetic patients with ischemic heart disease
Public title
Efficacy of Ranolazine in reduction of blood sugar in type 2 diabetic patients with ischemic heart disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
HbA1c more than 6.5%, Age more than 50 year, both genders with diabetes mellitus and coronary artery disease (CAD)
Experiencing chronic stable angina for at least 3 months triggered by physical effort and relieved by rest and/or sublingual nitroglycerin
CAD documented by one or more of the following: Angiography evidence of more than 50% stenosis of one or more coronary arteries, History of MI, cardiac imaging or exercise test diagnostic for CAD
Treatment with up to 2 anti-anginal therapies at a stable dose for at least 2 weeks before starting the trial
T2DM patients who use Metformin and Gliclazide
Exclusion criteria:
New York Heart Association class III and IV
Acute coronary syndrome in the prior 2 months or planned for coronary revascularization
Stroke or transient ischemic attack within 6 months prior
QTc more than 500 ms
Systolic blood pressure more than 180, diastolic blood pressure more than 110 mmHg
Liver cirrhosis
Prior treatment with CYP 3A4 inhibitors or P GlyP inductors
Treatment with anti arrhythmic medicine class ll and lll
Alcohol consumption or drug users
Simvastatin consumption
Age
From 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not 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 of Shahid Beheshti University of Medical Sciences
Street address
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
6153- 14155
Approval date
2015-11-30, 1394/09/09
Ethics committee reference number
IR.SBMU.PHNM.1394.308
Health conditions studied
1
Description of health condition studied
Diabetes mellitus
ICD-10 code
E11.0
ICD-10 code description
Type 2 diabetes mellitus with hyperosmolarity
2
Description of health condition studied
Stable angina
ICD-10 code
I20.8
ICD-10 code description
Other forms of angina pectoris
Primary outcomes
1
Description
Percentage of HbA1c
Timepoint
Per month
Method of measurement
Blood test Hitachi 911 automatic analyzer
Secondary outcomes
1
Description
Reduction of using sublingual nitroglycerin per week
Timepoint
Weekly
Method of measurement
Patient report
Intervention groups
1
Description
intervention group: treatment with Ranolazine (Ranexa) 1000 mg orally 2 times a day for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: continued their conventional therapy Nitroglycerin 2.6 mg orally twice a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Bahram Fariborz Farsad
Street address
Valiasr Ave Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 23921
Email
ffarsad@yahoo.com
Web page address
http://www.rhc.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Samin Daroo Company
Full name of responsible person
Dr Bahram Fariborz Farsad
Street address
Valiasr Ave Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 23921
Email
ffarsad@yahoo.com
Web page address
http://www.rhc.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Samin Daroo Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Rajaie cardiovascular, medical and research center
Full name of responsible person
Bahram Fariborz Farsad
Position
Clinical pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Valiasr Ave., Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 2266 3310
Fax
Email
ffarsad@yahoo.com
Web page address
http://www.rhc.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Bahram Fariborz Farsad
Position
Clinical pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Valiasr Ave., Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 2266 3310
Fax
Email
ffarsad@yahoo.com
Web page address
http://www.rhc.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Bahram Fariborz Farsad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Valiasr Ave., Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 2266 3310
Fax
Email
ffarsad@yahoo.com
Web page address
http://www.rhc.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data will be sent by email to those who are interested after the article published
When the data will become available and for how long
6 month after publishing the article
To whom data/document is available
Pharmacists and medical doctors
Under which criteria data/document could be used
Only for continue the researches which is suggested in the article
From where data/document is obtainable
Dr Farsad, Rajaie cardiovascular, medical and research center
What processes are involved for a request to access data/document