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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by Sulman Rafiq, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01046942
First Posted: January 12, 2010
Last Update Posted: September 24, 2013
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.
Information provided by (Responsible Party):
Sulman Rafiq, Rigshospitalet, Denmark
January 11, 2010
January 12, 2010
September 24, 2013
November 2008
May 2014   (Final data collection date for primary outcome measure)
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.
Graft patency at 3 months and 1 year [ Time Frame: 3 months, 1 year ]
Complete list of historical versions of study NCT01046942 on ClinicalTrials.gov Archive Site
  • 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.
  • Assessing coagulation profile pre- and postoperatively, including aspirin and clopidogrel resistance [ Time Frame: 3 months ]
  • Rate of other thromboembolic events( e.g. myocardial infarction,stroke, pulmonary embolus etc.) [ Time Frame: 3 months,1 year ]
  • Assessing coagulation profile pre- and postoperatively, including aspirin and clopidogrel resistance [ Time Frame: 1 year ]
Not Provided
Not Provided
 
ThrombElastoGraphic Haemostatic Status and Antiplatelet Therapy After Coronary Artery Bypass Graft Surgery
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).

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Graft Patency
  • Coronary Artery Bypass Grafting Surgery
  • Hypercoagulability
  • Thrombosis
  • 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
  • Drug: acetylsalicylic acid
    aspirin 75 mg daily, started 6-24 hours after surgery
    Other Names:
    • Aspirin
    • Magnyl
  • Experimental: Clopidogrel+Aspirin, hypercoagulabel
    Intervention: Drug: Clopidogrel+acetylsalicylic acid
  • Active Comparator: Aspirin,hypercoagulabel control
    Intervention: Drug: acetylsalicylic acid
Rafiq S, Johansson PI, Zacho M, Stissing T, Kofoed K, Lilleør NB, Steinbrüchel 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
250
September 2014
May 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01046942
H-C-2007-0057
No
Not Provided
Not Provided
Sulman Rafiq, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
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
Rigshospitalet, Denmark
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP