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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clopidogrel+Aspirin, hypercoagulabel | Experimental |
| |
| Aspirin,hypercoagulabel control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel+acetylsalicylic acid | Drug | loading dose clopidogrel 300mg on second postoperative day. Thereafter 75mg clopidogrel daily for 3 months Aspirin 75mg daily, started within 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sulman Rafiq, MD | Contact | (0045) 35458728 | sulman_raf@hotmail.com | |
| Daniel Steinbrüchel, Professor | Contact | (0045) 35458016 | daniel.steinbrüchel@rh.hosp.dk |
| Name | Affiliation | Role |
|---|---|---|
| Sulman Rafiq, MD | Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital | Study Director |
| Daniel Steinbrüchel, Professor | Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of cardiothoracic surgery, Rigshospitalet | Recruiting | Copenhagen | Kbh | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22540524 | Derived | 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. |
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|
| acetylsalicylic acid | Drug | aspirin 75 mg daily, started 6-24 hours after surgery |
|
|
| 3 months |
| Assessing coagulation profile pre- and postoperatively, including aspirin and clopidogrel resistance | 3 months |
| Pär Johansson, cons. MD,MPA | Blood Bank, Rigshospitalet, Copenhagen University Hospital | Study Director |
| 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 | Study Chair |
| ID | Term |
|---|---|
| D019851 | Thrombophilia |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D001241 | Aspirin |
| C024079 | aspirin, magnesium oxide combination |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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