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

• Conditions: Patients with coronary syndrome undergoing CABG in cardiopulmonary bypass receiving postoperative treatment with aspirin alone; MedDRA version: 9.1Level: LLTClassification code 10051592Term: Acute coronary syndrome

• Registration Number: EUCTR2007-003218-33-DK
• Lead Sponsor: Blood bank, Rigshospitalet, University Hospital of Copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-24
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 130

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

Exclusion Criteria

1.Age < 18 years

2.Cardiovascular
·ST-segment elevation myocardial infarction within 48 hours prior to randomization.
·Prior CABG within previous 4 weeks of randomization.
·Cardiogenic shock.
·Postoperative need for vasopressor and/or inotropic support postoperatively

3.Prior or concomitant therapy.
·Concurrent treatment with warfarin.

4.Hemorrhage risk
·History of bleeding diathesis or evidence of active abnormal bleeding within 30 days of randomization.
·Known haemophilia or thrombocytopathy (Glanzman´s thrombastenia, Bernard-Souliers sdm)
·History of hemorrhagic stroke at any time or stroke or TIA of any etiology within 30 days of randomization.
·Major surgery within 6 weeks prior to randomization.
·Known platelet count of <150,000/mm3.
·PT > 1.5 x control
·HCT < 25%
·Clinical signs of ongoing bleeding at time of inclusion (occult or overt)

5.General
·Known allergy or contraindication to aspirin or clopidogrel.
·Participation in a study of experimental therapy or device within prior 30 days.
·Creatinine level of greater than 4.0 mg/dl.
·Liver disease evidenced by ASAT/ALAT > 1.5 times normal
·Known history of alcohol or drug abuse.
·Pregnant women or women of child-bearing potential.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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