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

September 23, 2013 updated by: Sulman Rafiq, Rigshospitalet, Denmark

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Kbh
      • Copenhagen, Kbh, Denmark, 2100
        • Recruiting
        • Dep. of cardiothoracic surgery, Rigshospitalet
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
Assessing coagulation profile pre- and postoperatively, including aspirin and clopidogrel resistance
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

May 1, 2014

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

January 11, 2010

First Submitted That Met QC Criteria

January 11, 2010

First Posted (Estimate)

January 12, 2010

Study Record Updates

Last Update Posted (Estimate)

September 24, 2013

Last Update Submitted That Met QC Criteria

September 23, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-C-2007-0057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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