Thrombosis Clinical Trial
— TEG-CABGOfficial title:
ThrombElastoGraphic Haemostatic Status and Antiplatelet Therapy After Coronary Artery Bypass Graft Surgery(TEG-CABG Trial):Does Intensified Postoperative Antiplatelet Therapy in Preoperatively Identified Hypercoagulable Patients Improve Outcome After CABG Surgery
The purpose of this study is to determine whether adding clopidogrel to aspirin after coronary bypass operation (CABG) improves graft patency, in patients that have preoperatively increased platelet activity(hypercoagulable) and therefore greater risk of graft occlusion( thrombosis).
Status | Recruiting |
Enrollment | 250 |
Est. completion date | September 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Elective/subacute multivessel CABG - Isolated CABG procedure, no concomitant surgery - age > 18 years - Able to give informed consent Exclusion Criteria: - Myocardial infarction <48h of surgery - Prior CABG surgery within 1 month - Cardiac Shock within 48h of surgery - Atrial fibrillation - Anticoagulation therapy with VKA - ICH/TCI within 30 days - Prior peptic ulcerĀ· Platelet count < 150 E9 - Ongoing bleeding - Known platelet disease - Allergic to aspirin or clopidogrel - Liver disease with elevated ALAT/ASAT> 1,5x normal - Creatinine> 0,120mmol/l - Contrast allergy - Alcohol or narcotics abuse - Pregnancy - Not able to give informed consent - Geographically not available for follow up |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Dep. of cardiothoracic surgery, Rigshospitalet | Copenhagen | Kbh |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Graft patency at 3 months | Graft patency of Saphenous vein grafts will be significantly higher in TEG-Hypercoagulable patients on clopidogrel+aspirin vs. aspirin alone. | 3 months | No |
Secondary | Rate of other thromboembolic events( e.g. myocardial infarction,stroke, pulmonary embolus etc.)and cardiovascular death | In the TEG-Hypercoagulable intervention group (clopidogrel+aspirin) we expect significantly lower rates, of other thromboembolic events (e.g. myocardial infarction,stroke, pulmonary embolism etc) and cardiovascular death, compared to TEG-Hypercoagulable patients on aspirin monotherapy. | 3 months | No |
Secondary | Assessing coagulation profile pre- and postoperatively, including aspirin and clopidogrel resistance | 3 months | No |
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