ThrombElastoGraphic Haemostatic Status and Antiplatelet Therapy After Coronary Artery Bypass Graft Surgery (TEG-CABG)
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Graft Patency Coronary Artery Bypass Grafting Surgery Hypercoagulability Thrombosis||Drug: Clopidogrel+acetylsalicylic acid Drug: acetylsalicylic acid||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
U.S. FDA Resources
|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
- 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.
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT01046942
|Contact: Sulman Rafiq, MD||(0045) firstname.lastname@example.org|
|Contact: Daniel Steinbrüchel, Professor||(0045) 35458016||daniel.steinbrüchel@rh.hosp.dk|
|Dep. of cardiothoracic surgery, Rigshospitalet||Recruiting|
|Copenhagen, Kbh, Denmark, 2100|
|Contact: Sulman Rafiq, MD (0045) 35458728 email@example.com|
|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|