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

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Unknown status

CT.gov ID

NCT01046942

Collaborator

(none)

250

Enrollment

Location

Arms

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

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).

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

Study Type:

Interventional

Anticipated 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 :

Nov 1, 2008

Anticipated Primary Completion Date :

May 1, 2014

Anticipated Study Completion Date :

Sep 1, 2014

Arms and Interventions

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 Names: Plavix
Active Comparator: Aspirin,hypercoagulabel control	Drug: acetylsalicylic acid aspirin 75 mg daily, started 6-24 hours after surgery Other Names: Aspirin Magnyl

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 Names:

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

Primary Outcome Measures

Graft patency at 3 months [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 [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.
Assessing coagulation profile pre- and postoperatively, including aspirin and clopidogrel resistance [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dep. of cardiothoracic surgery, Rigshospitalet	Copenhagen	Kbh	Denmark	2100

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