ThrombElastoGraphic Haemostatic Status and Antiplatelet Therapy After Coronary Artery Bypass Graft Surgery (TEG-CABG)
Primary Purpose
Graft Patency, Coronary Artery Bypass Grafting Surgery, Hypercoagulability
Status
Unknown status
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Clopidogrel+acetylsalicylic acid
acetylsalicylic acid
Sponsored by
About this trial
This is an interventional treatment trial for Graft Patency focused on measuring 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
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
Sites / Locations
- Dep. of cardiothoracic surgery, RigshospitaletRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Clopidogrel+Aspirin, hypercoagulabel
Aspirin,hypercoagulabel control
Arm Description
Outcomes
Primary Outcome Measures
Graft patency at 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
Rate of other thromboembolic events( e.g. myocardial infarction,stroke, pulmonary embolus etc.)and cardiovascular death
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
Full Information
NCT ID
NCT01046942
First Posted
January 11, 2010
Last Updated
September 23, 2013
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT01046942
Brief Title
ThrombElastoGraphic Haemostatic Status and Antiplatelet Therapy After Coronary Artery Bypass Graft Surgery
Acronym
TEG-CABG
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
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clopidogrel+Aspirin, hypercoagulabel
Arm Type
Experimental
Arm Title
Aspirin,hypercoagulabel control
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Clopidogrel+acetylsalicylic acid
Other Intervention Name(s)
Plavix
Intervention Description
loading dose clopidogrel 300mg on second postoperative day. Thereafter 75mg clopidogrel daily for 3 months Aspirin 75mg daily, started within 24 hours after surgery
Intervention Type
Drug
Intervention Name(s)
acetylsalicylic acid
Other Intervention Name(s)
Aspirin, Magnyl
Intervention Description
aspirin 75 mg daily, started 6-24 hours after surgery
Primary Outcome Measure Information:
Title
Graft patency at 3 months
Description
Graft patency of Saphenous vein grafts will be significantly higher in TEG-Hypercoagulable patients on clopidogrel+aspirin vs. aspirin alone.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Rate of other thromboembolic events( e.g. myocardial infarction,stroke, pulmonary embolus etc.)and cardiovascular death
Description
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.
Time Frame
3 months
Title
Assessing coagulation profile pre- and postoperatively, including aspirin and clopidogrel resistance
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sulman Rafiq, MD
Phone
(0045) 35458728
Email
sulman_raf@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Steinbrüchel, Professor
Phone
(0045) 35458016
Email
daniel.steinbrüchel@rh.hosp.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sulman Rafiq, MD
Organizational Affiliation
Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Daniel Steinbrüchel, Professor
Organizational Affiliation
Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pär Johansson, cons. MD,MPA
Organizational Affiliation
Blood Bank, Rigshospitalet, Copenhagen University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Klaus Kofoed, cons.MD
Organizational Affiliation
Dep. of Cardiology, Rigshospitalet,Copenhagen University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mette Zacho, MD
Organizational Affiliation
Dept. of Radiology, Rigshospitalet, Copenhagen University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Trine Stissing, MD
Organizational Affiliation
Blood Bank, Rigshospitalet, Copenhagen University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Dep. of cardiothoracic surgery, Rigshospitalet
City
Copenhagen
State/Province
Kbh
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sulman Rafiq, MD
Phone
(0045) 35458728
Email
sulman_raf@hotmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
22540524
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.
Results Reference
derived
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ThrombElastoGraphic Haemostatic Status and Antiplatelet Therapy After Coronary Artery Bypass Graft Surgery
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