Patients with coronary syndrome undergoing CABG in cardiopulmonary bypass receiving postoperative treatment with aspirin alone MedDRA version: 9.1 Level: LLT Classification code 10051592 Term: Acute coronary syndrome
Conditions
Interventions
Trade Name: Clopidogrel
Product Name: Clopidogrel
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Plavix
CAS Number: 94188848
Current Sponsor code: Clopidogrel-1-CPH
Other descriptive name: CL
Sponsors
Blood bank, Rigshospitalet, University Hospital of Copenhagen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Patients undergoing elective CABG surgery in cardiopulmonary bypass · Age > 18 years and able to give informed consent · Stable vital signs within normal reference range (pulse within 20% of preoperatively, blood pressure within 10% of preoperatively, respiration frequency =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Age 1.5 x control · HCT 1.5 times normal · Known history of alcohol or drug abuse. · Pregnant women or women of child-bearing potential.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of additon of clopidogrel 75 mg daily for 6 months to lifelong aspirin in patients after CBAG on graft patency 3 months postoperatively;Secondary Objective: To evaluate the effect of additon of clopidogrel 75 mg daily for 6 months to lifelong aspirin in patients after CBAG on development of ischemic events within 6 months postoperatively;Primary end point(s): ·Graft patency evaluated by MSCT 3 months postoperatively | — |
Countries
Denmark
Outcome results
None listed