Clinical trial NCT01046942: ThrombElastoGraphic Haemostatic Status and Antiplatelet Therapy After Coronary Artery Bypass Graft Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Graft Patency
Coronary Artery Bypass Grafting Surgery
Hypercoagulability
Thrombosis
Keywords: Saphenous vein
Antiplatelet therapy
Hypercoagulable
Clopidogrel resistance
Aspirin resistance
Clopidogrel
Aspirin
Saphenous vein graft disease
TEG
Thrombelastography
Multiplate aggregometry
Multislice CT
Coronary artery bypass graft surgery
coagulation status
graft patency
CABG
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2010-01-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: Graft patency after CABG is reported to 80-90% worldwide 1 year following surgery. In the immediate period after surgery, and the following month, graft occlusion mainly occurs due to thrombosis.

Patients with platelet hyperreactivity have increased risk of thromboembolic events, including graft occlusion, myocardial infarction and stroke. Therefore intensifying the antiplatelet therapy in these patients, must be anticipated to have beneficial effects.

Hypercoagulable patients are identified with thrombelastography(TEG) as having a Maximal Amplitude(MA)\>69, thereafter randomized to either clopidogrel(3months) and aspirin or aspirin alone. At 3 months postoperative after surgery the coronary graft patency is assessed with Multislice CT scan.

Pre- and postoperatively, and then again at 3month followup, TEG and multiplate aggregometry are performed to assess platelet reactivity and resistance to aspirin and clopidogrel.

Eligibility criteria: 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 ulcer· 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

Primary outcomes:
measure: Graft patency at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Rate of other thromboembolic events( e.g. myocardial infarction,stroke, pulmonary embolus etc.)and cardiovascular death
timeFrame: 3 months
measure: Assessing coagulation profile pre- and postoperatively, including aspirin and clopidogrel resistance
timeFrame: 3 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dep. of cardiothoracic surgery, Rigshospitalet
state: Kbh
Study officials:
affiliation: Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital
name: Sulman Rafiq, MD
role: STUDY_DIRECTOR
affiliation: Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital
name: Daniel Steinbrüchel, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Blood Bank, Rigshospitalet, Copenhagen University Hospital
name: Pär Johansson, cons. MD,MPA
role: STUDY_DIRECTOR
affiliation: Dep. of Cardiology, Rigshospitalet,Copenhagen University Hospital
name: Klaus Kofoed, cons.MD
role: STUDY_CHAIR
affiliation: Dept. of Radiology, Rigshospitalet, Copenhagen University Hospital
name: Mette Zacho, MD
role: STUDY_CHAIR
affiliation: Blood Bank, Rigshospitalet, Copenhagen University Hospital
name: Trine Stissing, MD
role: STUDY_CHAIR
References:
citation: Rafiq S, Johansson PI, Zacho M, Stissing T, Kofoed K, Lilleor NB, Steinbruchel DA. 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. Trials. 2012 Apr 27;13:48. doi: 10.1186/1745-6215-13-48.