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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

History of Changes

Purpose

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	Intervention	Phase
Graft Patency Coronary Artery Bypass Grafting Surgery Hypercoagulability Thrombosis	Drug: Clopidogrel+acetylsalicylic acid Drug: acetylsalicylic acid	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: factor V Leiden thrombophilia prothrombin thrombophilia

MedlinePlus related topics: Coronary Artery Bypass Surgery

Drug Information available for: Aspirin Clopidogrel bisulfate

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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 ]


Estimated Enrollment:	250
Study Start Date:	November 2008
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046942

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

No publications provided by Rigshospitalet, Denmark

Additional 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
Study First Received:	January 11, 2010
Last Updated:	September 23, 2013
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:


Coronary artery bypass graft surgery Saphenous vein Antiplatelet therapy Hypercoagulable Clopidogrel resistance Aspirin resistance Clopidogrel Aspirin	Saphenous vein graft disease TEG Thrombelastography Multiplate aggregometry Multislice CT coagulation status graft patency CABG

Additional relevant MeSH terms:


Thrombophilia Thrombosis Cardiovascular Diseases Embolism and Thrombosis Hematologic Diseases Vascular Diseases Aspirin Clopidogrel Hemostatics Analgesics Analgesics, Non-Narcotic Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Antipyretics Antirheumatic Agents	Cardiovascular Agents Central Nervous System Agents Coagulants Cyclooxygenase Inhibitors Enzyme Inhibitors Fibrin Modulating Agents Fibrinolytic Agents Hematologic Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Platelet Aggregation Inhibitors Purinergic Agents

ClinicalTrials.gov processed this record on February 26, 2015

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