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

Rigshospitalet

Status and phase: Unknown; Phase 3

Conditions: Thrombosis; Hypercoagulability; Coronary Artery Bypass Grafting Surgery; Graft Patency

Treatments: Drug: Clopidogrel+acetylsalicylic acid; Drug: acetylsalicylic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01046942

H-C-2007-0057

Details and patient eligibility

About

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).

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

250 participants in 2 patient groups

Clopidogrel+Aspirin, hypercoagulabel

Experimental group

Treatment:

Drug: Clopidogrel+acetylsalicylic acid

Aspirin,hypercoagulabel control

Active Comparator group

Treatment:

Drug: acetylsalicylic acid