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

Thrombosis Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01046942
• Other study ID #: H-C-2007-0057
• Status: Recruiting
• Phase: Phase 3
• First received: January 11, 2010
• Last updated: September 23, 2013
• Start date: November 2008
• Est. completion date: September 2014

Study information

• Verified date: September 2013
• Source: Rigshospitalet, Denmark
• Contact: Sulman Rafiq, MD
• Phone: (0045) 35458728
• Email: sulman_raf[@]hotmail.com
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: September 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting Surgery
• Graft Patency
• Hypercoagulability
• Thrombophilia
• Thrombosis

Intervention

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

Locations

Country	Name	City	State
Denmark	Dep. of cardiothoracic surgery, Rigshospitalet	Copenhagen	Kbh

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months	No
Secondary	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.	3 months	No
Secondary	Assessing coagulation profile pre- and postoperatively, including aspirin and clopidogrel resistance		3 months	No