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IRCT20171113037434N1 IRCT 2018-01-10 Sanofi-Aventis Pharmaceutical Company Dual anti-platelet therapy in coronary artery bypass graft surgery DAPT in CABG 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 2012-05-01 anticipated 216 Complete https://irct.ir/trial/27752 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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. 2 coronary artery bypass graft. Intervention 1: 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. Intervention 2: Control group: Aspirin 80-325 mg/day. Yes - There is a plan to make this available What will be shared: - study protocol - De-identified Individual Participant Data Set (without patients' name, file number and medical center) - final report of the study When: After publishing the results of the study To whom: The mentioned data/documents will be available for all the stakeholders. Complementary data can be requested only by academic researchers. Conditions: Written permission from the primary investigator (Dr Abdi) is needed for any publication and usage of data. Where to obtain: Documents/ data will be available via contacting Dr Seyfollah Abdi: phone:02123921 or email: dr.abdi@rhc.ac.ir How to obtain: Only process is direct contact with primary investigator. Comments:
public Hooman Bakhshandeh
Niayesh-Valiasr cross roads
Tehran Iran (Islamic Republic of) 1995614331 +98 21 2392 3138 hooman.bakhshande@gmail.com Rajaie Cardiovascular Medical and Research Center scientific Hooman Bakhshandeh
Niayesh-Valiasr cross roads
Tehran Iran (Islamic Republic of) 1995614331 +98 21 2392 3138 hooman.bakhshande@gmail.com Rajaie Cardiovascular Medical and Research Center Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patients Age ≥18 year-old Candidate for elective coronary bypass graft surgery 18 years no limit Both 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 Z95.5 Presence of coronary angioplasty implant and graft Treatment - Drugs Treatment - Drugs 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. Control group: Aspirin 80-325 mg/day Graft patency. Timepoint: six months after CABG surgery. Method of measurement: coronary CT angiography. 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.). 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. In-hospital mortality. Timepoint: hospital stay duration. Method of measurement: observation. Sanofi-Aventis Pharmaceutical Company Approved 2011-10-31 Ethics committee of FACULTY OF NURSING AND MIDWIFERY, Karaj Islamic Azad University Imam Ali Complex, End of Rajaei-Shahr, Moazen Blvd - Esteghlal Crossroad, Karaj Alborz Iran (Islamic Republic of)