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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Condition or disease	Intervention/treatment	Phase
Graft Patency; Coronary Artery Bypass Grafting Surgery; Hypercoagulability; Thrombosis	Drug: Clopidogrel+acetylsalicylic acid; Drug: acetylsalicylic acid	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	250 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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; Other Names: Aspirin; Magnyl

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. Assessing coagulation profile pre- and postoperatively, including aspirin and clopidogrel resistance [ Time Frame: 3 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Contacts

Contact: Sulman Rafiq, MD	(0045) 35458728	sulman_raf@hotmail.com
Contact: Daniel Steinbrüchel, Professor	(0045) 35458016	daniel.steinbrüchel@rh.hosp.dk

Locations

Denmark
Dep. of cardiothoracic surgery, Rigshospitalet	Recruiting
Copenhagen, Kbh, Denmark, 2100
Contact: Sulman Rafiq, MD (0045) 35458728 sulman_raf@hotmail.com

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Sulman Rafiq, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT01046942 History of Changes
Other Study ID Numbers:	H-C-2007-0057
First Posted:	January 12, 2010
Last Update Posted:	September 24, 2013
Last Verified:	September 2013

Keywords provided by Sulman Rafiq, Rigshospitalet, Denmark:

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

Additional relevant MeSH terms:

Thrombosis; Thrombophilia; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hematologic Diseases; Aspirin; Ticlopidine; Clopidogrel; Hemostatics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents

Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents