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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Sulman Rafiq, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01046942
First received: January 11, 2010
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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).


Condition Intervention Phase
Graft Patency
Coronary Artery Bypass Grafting Surgery
Hypercoagulability
Thrombosis
Drug: Clopidogrel+acetylsalicylic acid
Drug: acetylsalicylic acid
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Graft patency at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Graft patency of Saphenous vein grafts will be significantly higher in TEG-Hypercoagulable patients on clopidogrel+aspirin vs. aspirin alone.


Secondary Outcome Measures:
  • Rate of other thromboembolic events( e.g. myocardial infarction,stroke, pulmonary embolus etc.)and cardiovascular death [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Assessing coagulation profile pre- and postoperatively, including aspirin and clopidogrel resistance [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: November 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Plavix
Active Comparator: Aspirin,hypercoagulabel control Drug: acetylsalicylic acid
aspirin 75 mg daily, started 6-24 hours after surgery
Other Names:
  • Aspirin
  • Magnyl

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046942

Contacts
Contact: Sulman Rafiq, MD (0045) 35458728 sulman_raf@hotmail.com
Contact: Daniel Steinbrüchel, Professor (0045) 35458016 daniel.steinbrüchel@rh.hosp.dk

Locations
Denmark
Dep. of cardiothoracic surgery, Rigshospitalet Recruiting
Copenhagen, Kbh, Denmark, 2100
Contact: Sulman Rafiq, MD    (0045) 35458728    sulman_raf@hotmail.com   
Sponsors and Collaborators
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
  More Information

No publications provided by Rigshospitalet, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sulman Rafiq, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01046942     History of Changes
Other Study ID Numbers: H-C-2007-0057
Study First Received: January 11, 2010
Last Updated: September 23, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:
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

Additional relevant MeSH terms:
Thrombosis
Thrombophilia
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Hematologic Diseases
Aspirin
Clopidogrel
Hemostatics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Purinergic P2Y Receptor Antagonists

ClinicalTrials.gov processed this record on September 22, 2014