title: Thrombelastographic haemostatic status and antiplatelet therapy after coronary artery bypass surgery (TEG-CABG trial): assessing and monitoring the antithrombotic effect of clopidogrel and aspirin versus aspirin alone in hypercoagulable patients: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Hypercoagulability, assessed by the thrombelastography (TEG) assay, has in several observational studies been associated with an increased risk of post-procedural thromboembolic complications. We hypothesize that intensified antiplatelet therapy with clopidogrel and aspirin, as compared to aspirin alone, will improve saphenous vein graft patency in preoperatively TEG-Hypercoagulable coronary artery bypass surgery (CABG) patients and reduce their risk for thromboembolic complications and death postoperatively.
  
  
  METHODS
  This is a prospective randomized clinical trial, with an open-label design with blinded evaluation of graft patency. TEG-Hypercoagulability is defined as a TEG maximum amplitude above 69 mm. Two hundred and fifty TEG-Hypercoagulable patients will be randomized to either an interventional group receiving clopidogrel 75 mg daily for three months (after initial oral bolus of 300 mg) together with aspirin 75 mg or a control group receiving aspirin 75 mg daily alone. Monitoring of antiplatelet efficacy and on-treatment platelet reactivity to clopidogrel and aspirin will be conducted with Multiplate aggregometry. Graft patency will be assessed with Multislice computed tomography (MSCT) at three months after surgery.
  
  
  CONCLUSIONS
  The present trial is the first randomized clinical trial to evaluate whether TEG-Hypercoagulable CABG patients will benefit from intensified antiplatelet therapy after surgery. Monitoring of platelet inhibition from instituted antithrombotic therapy will elucidate platelet resistance patterns after CABG surgery. The results could be helpful in redefining how clinicians can evaluate patients preoperatively for their postoperative thromboembolic risk and tailor individualized postoperative antiplatelet therapy.
  
  
  BACKGROUND
  Clinicaltrials.gov Identifier NCT01046942.
authors.affiliation: Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. sulman_raf@hotmail.com
authors.forename: Sulman
authors.initials: S
authors.lastname: Rafiq
authors.forename: Pär Ingemar
authors.initials: PI
authors.lastname: Johansson
authors.forename: Mette
authors.initials: M
authors.lastname: Zacho
authors.forename: Trine
authors.initials: T
authors.lastname: Stissing
authors.forename: Klaus
authors.initials: K
authors.lastname: Kofoed
authors.forename: Nikolaj Bang
authors.initials: NB
authors.lastname: Lilleør
authors.forename: Daniel Andreas
authors.initials: DA
authors.lastname: Steinbrüchel
mesh_terms: D001241:Aspirin / Q000008:administration & dosage / Q000627:therapeutic use*; D002985:Clinical Protocols; D000077144:Clopidogrel; D001026:Coronary Artery Bypass / Q000009:adverse effects*; D006801:Humans; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D011446:Prospective Studies; D013916:Thrombelastography; D013923:Thromboembolism / Q000517:prevention & control*; D019851:Thrombophilia / Q000188:drug therapy*; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin