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ThrombElastoGraphic Haemostatic Status and Antiplatelet Therapy After Coronary Artery Bypass Graft Surgery (TEG-CABG)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by Sulman Rafiq, Rigshospitalet, Denmark.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Rigshospitalet, Denmark
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
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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 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 Sulman Rafiq, Rigshospitalet, Denmark:
Primary Outcome Measures:
- Graft patency at 3 months [ Time Frame: 3 months ]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 ]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 ]
| 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:
|
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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01046942
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
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 |
Keywords provided by Sulman Rafiq, 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 Ticlopidine Clopidogrel Hemostatics Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on July 19, 2017