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Dual anti-platelet therapy in coronary artery bypass graft surgery

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20171113037434N1
Enrollment
216
Registered
2018-01-10
Start date
2012-05-01
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary artery bypass graft. Presence of coronary angioplasty implant and graft

Interventions

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 an
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
Control group: Aspirin 80-325 mg/day

Sponsors

Sanofi-Aventis Pharmaceutical Company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients Age =18 year-old Candidate for elective coronary bypass graft surgery

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Graft patency. Timepoint: six months after CABG surgery. Method of measurement: coronary CT angiography.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHooman Bakhshandeh

Rajaie Cardiovascular Medical and Research Center

hooman.bakhshande@gmail.com+98 21 2392 3138

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026