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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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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

sulman_raf@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Daniel Steinbrüchel, Professor

Phone

(0045) 35458016

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

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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