Investigation of the efficacy of dual anti-platelet therapy compared to aspirin on graft patency and peri-operative bleeding in coronary artery bypass graft surgery
superiority of dual anti-platelet therapy(DAPT)(Clopidogrel+Aspirin) compared to mono-therapy(Aspirin) on reduction of early graft occlusion after CABG will be assessed.
Design
In a multi-center, randomized controlled trial with parallel design (phase II) 216 patients will be randomly assigned to intervention(DAPT) or control(aspirin) group.
Settings and conduct
The trial is open-label and will be conducted in three centers for cardiovascular diseases in Tehran, Iran.
Participants/Inclusion and exclusion criteria
Inclusion: Age ≥18 year; Candidate for elective CABG.
Exclusion: Concomitant valve surgeries; Concomitant Aortic surgery; Redo-CABG; Not taking Aspirin at least 48 hours before surgery; Clopidogrel use within 5 days before CABG; Any condition with increased bleeding risk that precludes DAPT; Significant bleeding in the first 4 hours after surgery
Intervention groups
Intervention (DAPT): loading dose of 300 mg of Clopidogrel within 24 hours after surgery and a maintenance dose of 75 mg/day for 30 days in combination with 80-325 mg Aspirin
Control: Aspirin 80-325 mg/day
Main outcome variables
graft patency evaluated by a CT angiography 6 months after the surgery
General information
Reason for update
Acronym
DAPT in CABG
IRCT registration information
IRCT registration number:IRCT20171113037434N1
Registration date:2018-01-10, 1396/10/20
Registration timing:retrospective
Last update:2018-01-10, 1396/10/20
Update count:0
Registration date
2018-01-10, 1396/10/20
Registrant information
Name
Seifollah Abdi
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2356
Email address
dr.abdi@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2012-05-01, 1391/02/12
Expected recruitment end date
2015-12-30, 1394/10/09
Actual recruitment start date
2012-05-01, 1391/02/12
Actual recruitment end date
2015-12-30, 1394/10/09
Trial completion date
empty
Scientific title
Investigation of the efficacy of dual anti-platelet therapy compared to aspirin on graft patency and peri-operative bleeding in coronary artery bypass graft surgery
Public title
Dual anti-platelet therapy in coronary artery bypass graft surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients Age ≥18 year-old
Candidate for elective coronary bypass graft surgery
Exclusion criteria:
1) Concomitant valve surgeries
2) Concomitant Aortic surgery
3) Redo-CABGs
4) Patients who don't take Aspirin at least 48 hours before surgery
5) Clopidogrel use within 5 days before CABG
6) Any condition with increased bleeding risk that precludes dual anti-platelet therapy
7) Significant bleeding in the first 4 hours after surgery
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
216
Actual sample size reached:
140
Randomization (investigator's opinion)
Randomized
Randomization description
The participants in this study will be randomized (on a 1: 1 basis) using permuted block method to either dual anti-platelet therapy group (Clopidogrel and Aspirin) or Aspirin monotherapy group within 24 hours after surgery. The process of random assignment will be conducted in our data management center (DMC) a center, located in one of the collaborating hospitals (Rajaie Cardiovascular Medical and Research Center) by the team members do not involve in the conduction of the trial performed. Random sequence will be generated using permuted block randomization method (block of four). After registration of each patient in the trial, the responsible nurse called the center DMC and asked for the assigned study group. According to the random sequence, the staff in the center will announce the assigned group as "Group A" (DAPT) or "Group B" (control) to the nurse.
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 FACULTY OF NURSING AND MIDWIFERY, Karaj Islamic Azad University
Street address
Imam Ali Complex, End of Rajaei-Shahr, Moazen Blvd - Esteghlal Crossroad,
City
Karaj
Province
Alborz
Postal code
3148635731
Approval date
2011-10-31, 1390/08/09
Ethics committee reference number
1390/8/9-29
Health conditions studied
1
Description of health condition studied
coronary artery bypass graft
ICD-10 code
Z95.5
ICD-10 code description
Presence of coronary angioplasty implant and graft
Primary outcomes
1
Description
graft patency
Timepoint
six months after CABG surgery
Method of measurement
coronary CT angiography
Secondary outcomes
1
Description
The amount of chest tube output
Timepoint
four hours after surgery
Method of measurement
Measuring the chest tube drainage (it will be considered significant when its amount is more than 100 cm3 per hour in average for a 4 hours interval in ICU after surgery.)
2
Description
The need for blood transfusions with either of the following:a. ≥ 2 units of packed red blood cells b. ≥ 2 units of fresh frozen plasma c. ≥ 5 units of platelets
Timepoint
hospital stay duration
Method of measurement
Counting the transfused products units
3
Description
In-hospital mortality
Timepoint
hospital stay duration
Method of measurement
observation
Intervention groups
1
Description
Intervention group: Dual anti-platelet therapy (DAPT) group received a loading dose of 300 mg (4 tablets) of Clopidogrel (Plavix ®, Sanofi-Aventis Co.) within 24 hours after surgery and a maintenance dose of 75 mg/day was continued for 30 days in combination with 80-325 mg Aspirin.
Category
Treatment - Drugs
2
Description
Control group: Aspirin 80-325 mg/day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Seyfollah Abdi
Street address
Valiasr Ave Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
dr.abdi@rhc.ac.ir
Web page address
http://www.rhc.ac.ir
2
Recruitment center
Name of recruitment center
Day General Hospital
Full name of responsible person
Seyfollah Abdi
Street address
Valiasr Ave Abbaspour St. Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 8879 7111
Email
dr.abdi@rhc.ac.ir
Web page address
http://www.daygeneralhospital.ir
3
Recruitment center
Name of recruitment center
Pars General Hospital
Full name of responsible person
Seyfollah Abdi
Street address
No.67- Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1415944911
Phone
+98 21 8896 0051
Fax
+98 21 8896 6052
Email
dr.abdi@rhc.ac.ir
Web page address
http://www.parsgeneralhospital.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanofi-Aventis Pharmaceutical Company
Full name of responsible person
Nariman Sadri
Street address
18, 35th Str, Alvand Ave, Argentine Sq.
City
Tehran
Province
Tehran
Postal code
1516683511
Phone
+98 21 8864 9700
Email
info@sanofi-aventis.com
Web page address
http://www.sanofi.us/l/us/en/index.jsp
Grant name
Grant code / Reference number
CLOPI_L_05766
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanofi-Aventis Pharmaceutical 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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Hooman Bakhshandeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Niayesh-Valiasr cross roads
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 3138
Fax
+98 21 2266 3217
Email
hooman.bakhshande@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Hooman Bakhshandeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Niayesh-Valiasr cross roads
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 3138
Fax
+98 21 2266 3217
Email
hooman.bakhshande@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Hooman Bakhshandeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Niayesh-Valiasr cross roads
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 3138
Fax
+98 21 2266 3217
Email
hooman.bakhshande@gmail.com
Web page address
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
No - There is not a plan to make this available
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
- study protocol
- De-identified Individual Participant Data Set (without patients' name, file number and medical center)
- final report of the study
When the data will become available and for how long
After publishing the results of the study
To whom data/document is available
The mentioned data/documents will be available for all the stakeholders. Complementary data can be requested only by academic researchers.
Under which criteria data/document could be used
Written permission from the primary investigator (Dr Abdi) is needed for any publication and usage of data.
From where data/document is obtainable
Documents/ data will be available via contacting Dr Seyfollah Abdi: phone:02123921 or email: dr.abdi@rhc.ac.ir
What processes are involved for a request to access data/document
Only process is direct contact with primary investigator.