Coronary Artery DiseaseTARGET-CABGNCT00857155
Time Based Strategy to Reduce Clopidogrel Associated Bleeding Related to Coronary Artery Bypass Graft (CABG)
A study testing Clopidogrel withdraw prior to CABG in people with Coronary Artery Disease, run by LifeBridge Health at 1 site in United States.
Trial summary
Purpose: In patients with coronary artery disease, aspirin and Plavix are used increasingly to prevent the formation of blood clots in the coronary arteries. These drugs exert their beneficial effects by irreversibly blocking platelets, the compounds found in blood responsible for clotting after an injury or during a… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Clopidogrel withdraw prior to CABG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Feb 2011
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must provide written informed consent.
- Patients must currently be on aspirin therapy (81-325 mg).
- Male or female patients between the ages of 18-85 requiring CABG.
Who cannot join
- Patients undergoing emergent surgery following failed percutaneous coronary revascularization.
- Patients with a history of previous cardiac surgery and patients needing concomitant valvular surgery.
- Pre-operative exposure to either coumadin or platelet GPIIb/IIIa inhibitors.
- Patients with a history of bleeding diathesis.
- Patients with an activated partial thrombin time >1.5 normal.
- Patients with platelet count <120,000/mm3.
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- Patients with hematocrit <30%.
- Patients with creatinine clearance <30mL/min.
- Patients with known active hepatic disease.
- Patients with any other condition that, in the opinion of the investigator, may either put the patient at risk or influence the result of the study (e.g. malignancy, limiting life expectancy, noncompliance).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sinai Hospital
Baltimore, Maryland, 21215
Kevin P Bliden
About this study
Purpose: In patients with coronary artery disease, aspirin and Plavix are used increasingly to prevent the formation of blood clots in the coronary arteries. These drugs exert their beneficial effects by irreversibly blocking platelets, the compounds found in blood responsible for clotting after an injury or during a heart attack. However, these effects also place patients at increased risk for bleeding after coronary artery bypass surgery. Therefore, it is currently recommended to withhold Plavix therapy for 5 days before undergoing surgery in order to reduce the incidence of bleeding. However, it has been repeatedly shown that Plavix exerts variable effects on different patients, which may be partially explained by poor absorption, drug-drug interaction, and by variations in deoxyribonucleic acid (DNA) which constitutes your genes. In addition, the time required for platelets to regain function after Plavix treatment has been shown to vary between patients. Therefore, by measuring platelet function, it may be possible to determine the optimal amount of time required to withhold Plavix before undergoing bypass surgery, which may improve rates of bleeding following the procedure. The purpose of this study is to classify patients into groups based on platelet function in order to define the ideal time period for delaying surgery. By analyzing the amount of time required for platelet recovery, it is expected that surgery-related bleeding will decrease without increasing the risk of blood clot formation.
Eligibility: Approximately 200 patients requiring CABG will be enrolled at Sinai Hospital, which is the only site where this study is being conducted.
Read more
To be eligible you must:
- Be able to provide written informed consent.
- Be between the ages of 18-85 and require CABG.
- Currently be on aspirin therapy (81-325mg).
Read the detailed description
Primary objective:
We hypothesize that stratifying patients on clopidogrel into time-based platelet function recovery groups as determined by pre-operative clopidogrel response measured by point of care methods will result in similar rates of bleeding as compared to those of clopidogrel naïve patients undergoing elective CABG.
Study design:
This will be a single center, prospective study analyzing clopidogrel naïve patients and patients on clopidogrel with background aspirin therapy requiring CABG.
- Conditions
- Coronary Artery Disease
- Being tested
- Clopidogrel withdraw prior to CABG
- Keywords
- Coronary Artery Disease, CABG, Clopidogrel, Aspirin, Point of Care devices
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel withdraw prior to CABGOther
Patients on clopidogrel are stratified into time-based platelet function recovery groups as determined by point of care methods and based on these groups clopidogrel is withdrawn at a pre-specified timepoint before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin only | No intervention | Continue aspirin until surgery |
| Clopidogrel and Aspirin | Other | Not described Receives: Other: Clopidogrel withdraw prior to CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is chest tube drainage.
Measured: During the index hospitalization
Secondary outcomes (1)
The secondary endpoint is transfusion requirements.
Measured: Index hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2011 (estimated)
- Study completionFeb 2011 (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 Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LifeBridge Health
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857155
- Sponsor's protocol ID
- IRB# 1464
- Acronym
- TARGET-CABG
- Status last verified
- Mar 2009
- First submitted
- 4 Mar 2009
- Last updated
- 6 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Mahla E, Suarez TA, Bliden KP, Rehak P, Metzler H, Sequeira AJ, Cho P, Sell J, Fan J, Antonino MJ, Tantry US, Gurbel PA. Platelet function measurement-based strategy to reduce bleeding and waiting time in clopidogrel-treated patients undergoing coronary artery bypass graft surgery: the timing based on platelet function strategy to reduce clopidogrel-associated bleeding related to CABG (TARGET-CABG) study. Circ Cardiovasc Interv. 2012 Apr;5(2):261-9. doi: 10.1161/CIRCINTERVENTIONS.111.967208. Epub 2012 Mar 6.
PubMed 22396581
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Based Strategy to Reduce Clopidogrel Associated Bleeding Related to Coronary Artery Bypass Graft (CABG)
- ClinicalTrials.gov ID
- NCT00857155
- Acronym / sponsor ID
- TARGET-CABG / IRB# 1464
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, CABG, Clopidogrel, Aspirin, Point of Care devices
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- LifeBridge HealthUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 6 Mar 2009 (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.
Purpose: In patients with coronary artery disease, aspirin and Plavix are used increasingly to prevent the formation of blood clots in the coronary arteries. These drugs exert their beneficial effects by irreversibly blocking platelets, the compounds found in blood responsible for clotting after an injury or during a heart attack. However, these effects also place patients at increased risk for bleeding after coronary artery bypass surgery. Therefore, it is currently recommended to withhold Plavix therapy for 5 days before undergoing surgery in order to reduce the incidence of bleeding. However, it has been repeatedly shown that Plavix exerts variable effects on different patients, which may be partially explained by poor absorption, drug-drug interaction, and by variations in deoxyribonucleic acid (DNA) which constitutes your genes. In addition, the time required for platelets to regain function after Plavix treatment has been shown to vary between patients. Therefore, by measuring platelet function, it may be possible to determine the optimal amount of time required to withhold Plavix before undergoing bypass surgery, which may improve rates of bleeding following the procedure. The purpose of this study is to classify patients into groups based on platelet function in order to define the ideal time period for delaying surgery. By analyzing the amount of time required for platelet recovery, it is expected that surgery-related bleeding will decrease without increasing the risk of blood clot formation.
Eligibility: Approximately 200 patients requiring CABG will be enrolled at Sinai Hospital, which is the only site where this study is being conducted.
To be eligible you must:
- Be able to provide written informed consent.
- Be between the ages of 18-85 and require CABG.
- Currently be on aspirin therapy (81-325mg).
Detailed description
Primary objective:
We hypothesize that stratifying patients on clopidogrel into time-based platelet function recovery groups as determined by pre-operative clopidogrel response measured by point of care methods will result in similar rates of bleeding as compared to those of clopidogrel naïve patients undergoing elective CABG.
Study design:
This will be a single center, prospective study analyzing clopidogrel naïve patients and patients on clopidogrel with background aspirin therapy requiring CABG.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin only | No intervention | –Continue aspirin until surgery |
| Clopidogrel and Aspirin | Other | Other: Clopidogrel withdraw prior to CABG |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must provide written informed consent.
- Patients must currently be on aspirin therapy (81-325 mg).
- Male or female patients between the ages of 18-85 requiring CABG.
Key exclusion criteria (10 listed)
- Patients undergoing emergent surgery following failed percutaneous coronary revascularization.
- Patients with a history of previous cardiac surgery and patients needing concomitant valvular surgery.
- Pre-operative exposure to either coumadin or platelet GPIIb/IIIa inhibitors.
- Patients with a history of bleeding diathesis.
- Patients with an activated partial thrombin time >1.5 normal.
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 withdraw prior to CABGPatients on clopidogrel are stratified into time-based platelet function recovery groups as determined by point of care methods and based on these groups clopidogrel is withdrawn at a pre-specified timepoint before surgery. | Other | Clopidogrel and Aspirin |
Primary outcome
The primary endpoint is chest tube drainage.
Time frame: During the index hospitalization
1 secondary outcome
The secondary endpoint is transfusion requirements.
Time frame: Index hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2009.
- Derived from this study: PubMed 22396581Mahla E, Suarez TA, Bliden KP, Rehak P, Metzler H, Sequeira AJ, Cho P, Sell J, Fan J, Antonino MJ, Tantry US, Gurbel PA. Platelet function measurement-based strategy to reduce bleeding and waiting time in clopidogrel-treated patients undergoing coronary artery bypass graft surgery: the timing based on platelet function strategy to reduce clopidogrel-associated bleeding related to CABG (TARGET-CABG) study. Circ Cardiovasc Interv. 2012 Apr;5(2):261-9. doi: 10.1161/CIRCINTERVENTIONS.111.967208. Epub 2012 Mar 6.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clopidogrel withdraw prior to CABG in people with Coronary Artery Disease, run by LifeBridge Health at 1 site in United States.
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 3 inclusion and 10 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 6 Mar 2009. 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 United States. 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.
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 Kevin P Bliden, BS (4106014795, kbliden@lifebridgehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is chest tube drainage. (time frame: During the index hospitalization). 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 NCT00857155, 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 6 Mar 2009.