Antitrombotisk effekt af ADP receptor inhibitor i tillæg til Aspirin til hyperkoagulable patienter der gennemgår CABG kirurgi.

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2007
INTERVENTION: 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: CLOPIDOGREL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75‐150 Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Enteral use (Noncurrent) CONDITION: 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 PRIMARY OUTCOME: 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 Primary end point(s): · Graft patency evaluated by MSCT 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 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 <18 breaths/min, normal consciousness) on the 1st postoperative day at time of inclusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 31b3aa6ef9d6dfda2d933658ff55cadf37f73b69
First added on: Aug 21, 2024