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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Sulman Rafiq, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01046942
First received: January 11, 2010
Last updated: September 23, 2013
Last verified: September 2013

January 11, 2010
September 23, 2013
November 2008
May 2014   (final data collection date for primary outcome measure)
Graft patency at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Rate of other thromboembolic events( e.g. myocardial infarction,stroke, pulmonary embolus etc.) [ Time Frame: 3 months,1 year ] [ Designated as safety issue: No ]
  • Assessing coagulation profile pre- and postoperatively, including aspirin and clopidogrel resistance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Recruiting
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
Both
18 Years and older
No
Contact: Sulman Rafiq, MD (0045) 35458728 sulman_raf@hotmail.com
Contact: Daniel Steinbrüchel, Professor (0045) 35458016 daniel.steinbrüchel@rh.hosp.dk
Denmark
 
NCT01046942
H-C-2007-0057
No
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