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ThrombElastoGraphic Haemostatic Status and Antiplatelet Therapy After Coronary Artery Bypass Graft Surgery (TEG-CABG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01046942
Recruitment Status : Unknown
Verified September 2013 by Sulman Rafiq, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : January 12, 2010
Last Update Posted : September 24, 2013
Information provided by (Responsible Party):
Sulman Rafiq, Rigshospitalet, Denmark

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).

Condition or disease Intervention/treatment Phase
Graft Patency Coronary Artery Bypass Grafting Surgery Hypercoagulability Thrombosis Drug: Clopidogrel+acetylsalicylic acid Drug: acetylsalicylic acid Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2008
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: Clopidogrel+Aspirin, hypercoagulabel Drug: Clopidogrel+acetylsalicylic acid
loading dose clopidogrel 300mg on second postoperative day. Thereafter 75mg clopidogrel daily for 3 months Aspirin 75mg daily, started within 24 hours after surgery
Other Name: Plavix

Active Comparator: Aspirin,hypercoagulabel control Drug: acetylsalicylic acid
aspirin 75 mg daily, started 6-24 hours after surgery
Other Names:
  • Aspirin
  • Magnyl

Primary Outcome Measures :
  1. Graft patency at 3 months [ Time Frame: 3 months ]
    Graft patency of Saphenous vein grafts will be significantly higher in TEG-Hypercoagulable patients on clopidogrel+aspirin vs. aspirin alone.

Secondary Outcome Measures :
  1. Rate of other thromboembolic events( e.g. myocardial infarction,stroke, pulmonary embolus etc.)and cardiovascular death [ Time Frame: 3 months ]
    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.

  2. Assessing coagulation profile pre- and postoperatively, including aspirin and clopidogrel resistance [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01046942

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Contact: Sulman Rafiq, MD (0045) 35458728
Contact: Daniel Steinbrüchel, Professor (0045) 35458016 daniel.steinbrü

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Dep. of cardiothoracic surgery, Rigshospitalet Recruiting
Copenhagen, Kbh, Denmark, 2100
Contact: Sulman Rafiq, MD    (0045) 35458728   
Sponsors and Collaborators
Rigshospitalet, Denmark
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Study Director: Sulman Rafiq, MD Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital
Principal Investigator: Daniel Steinbrüchel, Professor Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital
Study Director: Pär Johansson, cons. MD,MPA Blood Bank, Rigshospitalet, Copenhagen University Hospital
Study Chair: Klaus Kofoed, cons.MD Dep. of Cardiology, Rigshospitalet,Copenhagen University Hospital
Study Chair: Mette Zacho, MD Dept. of Radiology, Rigshospitalet, Copenhagen University Hospital
Study Chair: Trine Stissing, MD Blood Bank, Rigshospitalet, Copenhagen University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sulman Rafiq, MD, Rigshospitalet, Denmark Identifier: NCT01046942    
Other Study ID Numbers: H-C-2007-0057
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: September 24, 2013
Last Verified: September 2013
Keywords provided by Sulman Rafiq, Rigshospitalet, Denmark:
Saphenous vein
Antiplatelet therapy
Clopidogrel resistance
Aspirin resistance
Saphenous vein graft disease
Multiplate aggregometry
Multislice CT
Coronary artery bypass graft surgery
coagulation status
graft patency
Additional relevant MeSH terms:
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Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Hematologic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents