Graft PatencyPhase 3TEG-CABGNCT01046942
ThrombElastoGraphic Haemostatic Status and Antiplatelet Therapy After Coronary Artery Bypass Graft Surgery
A Phase 3 study testing Clopidogrel+acetylsalicylic acid and acetylsalicylic acid in people with Graft Patency and Coronary Artery Bypass Grafting Surgery, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Patency, Coronary Artery Bypass Grafting Surgery, Hypercoagulability
- What is being tested?
- Clopidogrel+acetylsalicylic acid and acetylsalicylic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2008to Sep 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective/subacute multivessel CABG
- Isolated CABG procedure, no concomitant surgery
- age > 18 years
- Able to give informed consent
Who cannot join
- 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
Show all 17Show fewer
- 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 locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Dep. of cardiothoracic surgery, Rigshospitalet
Copenhagen, Kbh, 2100
Sulman Rafiq, MD, (0045) 35458728, sulman_raf@hotmail.com
About this study
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
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).
Read the 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.
- Being tested
- Clopidogrel+acetylsalicylic acid, acetylsalicylic acid
- 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
- Medical subject headings
- Thrombophilia, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel+acetylsalicylic acidDrug
Also called Plavix
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 acidDrug
Also called Aspirin, Magnyl
aspirin 75 mg daily, started 6-24 hours after surgery
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel+Aspirin, hypercoagulabel | Experimental | Not described Receives: Drug: Clopidogrel+acetylsalicylic acid |
| Aspirin,hypercoagulabel control | Active comparator | Not described Receives: Drug: acetylsalicylic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 3 months
Assessing coagulation profile pre- and postoperatively, including aspirin and clopidogrel resistance
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startNov 2008
- Primary completionMay 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graft PatencyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sulman Rafiq, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Sulman Rafiq, MD, Study director, Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University HospitalDaniel Steinbrüchel, Professor, Principal investigator, Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University HospitalPär Johansson, cons. MD,MPA, Study director, Blood Bank, Rigshospitalet, Copenhagen University HospitalKlaus Kofoed, cons.MD, Study chair, Dep. of Cardiology, Rigshospitalet,Copenhagen University HospitalMette Zacho, MD, Study chair, Dept. of Radiology, Rigshospitalet, Copenhagen University HospitalTrine Stissing, MD, Study chair, Blood Bank, Rigshospitalet, Copenhagen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046942
- Sponsor's protocol ID
- H-C-2007-0057
- Acronym
- TEG-CABG
- Status last verified
- Sep 2013
- First submitted
- 11 Jan 2010
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22540524
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01046942
- Acronym / sponsor ID
- TEG-CABG / H-C-2007-0057
- Keywords
- Saphenous vein, Antiplatelet therapy, Hypercoagulable, Clopidogrel resistance, Aspirin resistance, Clopidogrel, Aspirin, Saphenous vein graft disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- May 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel+Aspirin, hypercoagulabel | Experimental | Drug: Clopidogrel+acetylsalicylic acid |
| Aspirin,hypercoagulabel control | Active comparator | Drug: acetylsalicylic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective/subacute multivessel CABG
- Isolated CABG procedure, no concomitant surgery
- age > 18 years
- Able to give informed consent
Key exclusion criteria (17 listed)
- Myocardial infarction <48h of surgery
- Prior CABG surgery within 1 month
- Cardiac Shock within 48h of surgery
- Atrial fibrillation
- Anticoagulation therapy with VKA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clopidogrel+acetylsalicylic acidAlso: Plavixloading dose clopidogrel 300mg on second postoperative day. Thereafter 75mg clopidogrel daily for 3 months Aspirin 75mg daily, started within 24 hours after surgery | Drug | Clopidogrel+Aspirin, hypercoagulabel |
| acetylsalicylic acidAlso: Aspirin, Magnylaspirin 75 mg daily, started 6-24 hours after surgery | Drug | Aspirin,hypercoagulabel control |
Primary outcome
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.
2 secondary outcomes
Rate of other thromboembolic events( e.g. myocardial infarction,stroke, pulmonary embolus etc.)and cardiovascular death
Time frame: 3 months
Assessing coagulation profile pre- and postoperatively, including aspirin and clopidogrel resistance
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2013.
- Derived from this study: PubMed 22540524Rafiq 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sulman Rafiq, MD study director
Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital
Daniel Steinbrüchel, Professor principal investigator
Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital
Pär Johansson, cons. MD,MPA study director
Blood Bank, Rigshospitalet, Copenhagen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clopidogrel+acetylsalicylic acid and acetylsalicylic acid in people with Graft Patency and Coronary Artery Bypass Grafting Surgery, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sulman Rafiq, MD ((0045) 35458728, sulman_raf@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft patency at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01046942, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2013.