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ThrombElastoGraphic Haemostatic Status and Antiplatelet Therapy After Coronary Artery Bypass Graft Surgery

NCT ID: NCT01046942

Last Updated: 2013-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2014-09-30

Brief Summary

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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

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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.

Conditions

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Graft Patency Coronary Artery Bypass Grafting Surgery Hypercoagulability Thrombosis

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Clopidogrel+Aspirin, hypercoagulabel

Group Type EXPERIMENTAL

Clopidogrel+acetylsalicylic acid

Intervention Type DRUG

loading dose clopidogrel 300mg on second postoperative day. Thereafter 75mg clopidogrel daily for 3 months Aspirin 75mg daily, started within 24 hours after surgery

Aspirin,hypercoagulabel control

Group Type ACTIVE_COMPARATOR

acetylsalicylic acid

Intervention Type DRUG

aspirin 75 mg daily, started 6-24 hours after surgery

Interventions

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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

Intervention Type DRUG

acetylsalicylic acid

aspirin 75 mg daily, started 6-24 hours after surgery

Intervention Type DRUG

Other Intervention Names

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Plavix Aspirin Magnyl

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Sulman Rafiq

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sulman Rafiq, MD

Role: STUDY_DIRECTOR

Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital

Daniel Steinbrüchel, Professor

Role: PRINCIPAL_INVESTIGATOR

Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital

Pär Johansson, cons. MD,MPA

Role: STUDY_DIRECTOR

Blood Bank, Rigshospitalet, Copenhagen University Hospital

Klaus Kofoed, cons.MD

Role: STUDY_CHAIR

Dep. of Cardiology, Rigshospitalet,Copenhagen University Hospital

Mette Zacho, MD

Role: STUDY_CHAIR

Dept. of Radiology, Rigshospitalet, Copenhagen University Hospital

Trine Stissing, MD

Role: STUDY_CHAIR

Blood Bank, Rigshospitalet, Copenhagen University Hospital

Locations

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Dep. of cardiothoracic surgery, Rigshospitalet

Copenhagen, Kbh, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Sulman Rafiq, MD

Role: CONTACT

Phone: (0045) 35458728

Email: [email protected]

Daniel Steinbrüchel, Professor

Role: CONTACT

Phone: (0045) 35458016

Email: daniel.steinbrü[email protected]

Facility Contacts

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Sulman Rafiq, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 22540524 (View on PubMed)

Other Identifiers

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H-C-2007-0057

Identifier Type: -

Identifier Source: org_study_id