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

Blood bank, Rigshospitalet, University Hospital of Copenhagen0 个研究点目标入组 130 人开始时间: 2007年7月24日最近更新: 2013年4月22日

适应症

试验速览

暂无简介。

•·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

•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)
•·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.

发起方

Blood bank, Rigshospitalet, University Hospital of Copenhagen