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

NCT01046942 | Unknown Phase 3

• 1 other identifier: H-C-2007-0057
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Rate of other thromboembolic events( e.g. myocardial infarction,stroke, pulmonary embolus etc.)and cardiovascular death

  3 months

• Assessing coagulation profile pre- and postoperatively, including aspirin and clopidogrel resistance

  3 months

Study Arms (2)

Clopidogrel+Aspirin, hypercoagulabel

EXPERIMENTAL

Drug: Clopidogrel+acetylsalicylic acid

Aspirin,hypercoagulabel control

ACTIVE COMPARATOR

Drug: acetylsalicylic acid

Interventions

Clopidogrel+acetylsalicylic acid 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

Also known as: Plavix

Clopidogrel+Aspirin, hypercoagulabel

acetylsalicylic acid DRUG

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

Also known as: Aspirin, Magnyl

Aspirin,hypercoagulabel control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective/subacute multivessel CABG
• Isolated CABG procedure, no concomitant surgery
• age \> 18 years
• Able to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Dep. of cardiothoracic surgery, Rigshospitalet

Copenhagen, Kbh, 2100, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 22540524 DERIVED

MeSH Terms

Conditions

Thrombophilia; Thrombosis

Interventions

Clopidogrel; Aspirin; aspirin, magnesium oxide combination

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Sulman Rafiq, MD

  Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital

  STUDY DIRECTOR

• Daniel Steinbrüchel, Professor

  Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital

  PRINCIPAL INVESTIGATOR

• Pär Johansson, cons. MD,MPA

  Blood Bank, Rigshospitalet, Copenhagen University Hospital

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Central Study Contacts

Sulman Rafiq, MD

CONTACT

(0045) 35458728; sulman_raf@hotmail.com

Daniel Steinbrüchel, Professor

CONTACT

(0045) 35458016; daniel.steinbrüchel@rh.hosp.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 12, 2010
• Study Start: November 1, 2008
• Primary Completion: May 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 24, 2013

Record last verified: 2013-09

Locations

DK (1)