Coronary Artery DiseasePhase 4NCT00724880
Effect of Clopidogrel (Plavix) on Postoperative Bleeding in Patients Undergoing Coronary Artery Bypass Surgery.
A Phase 4 study testing Clopidogrel in people with Coronary Artery Disease, run by Catharina Ziekenhuis Eindhoven.
Trial summary
Running title: Effect of Clopidogrel on Postoperative Bleeding in Patients undergoing Coronary Artery Bypass Surgery Title: Clopidogrel and bleeding in patients undergoing coronary artery bypass grafting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Dec 2007
- Phase
- Phase 4
- 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
- Patients who are using clopidogrel at least 5 days before surgery with a dose of 75 mg clopidogrel without loading dose with or without concomitant use of aspirin.
- Patients who received a loading dose of 300-600 mg clopidogrel 24 hours before CABG, with or without concomitant use of aspirin
- Patients approved for elective or urgent CABG surgery
Who cannot join
- Patients who are concomitant using oral coumarin derivates, heparine derivates iv., dipiridamol or other anticoagulant treatment, 5 days before operation.
- Patients with pre-existing bleeding disorders, thrombocytopenia
- Patients who have renal insufficiency (creatinine >2.0 mg/dL) or chronic renal failure requiring dialysis
- Patients in end stage heart failure
- Patients who have evidence of significant hepatic disease including clinical signs or laboratory values of total bilirubin> 2.0 mg/dL, ALAT or ASAT> 3X upper limit of normal, or INR >2X upper limit of normal (not due to anticoagulation therapy)
- Emergency bypass surgery when patients cant be random enrolled in one of the three groups
Show all 15Show fewer
- Concomitant valvular or other cardiac procedures
- Re-operation (patients known with previous heart operations)
- Off-pump CABG
- Chronic alcoholism
- Immediate post operative complications that in the opinion of the investigator can alter the further results of the trial (thromboembolism or ischemic CVA with use of anticoagulants, severe liver function disorders, sepsis, disseminated intravascular coagulation, adverse effects to blood products, etc)
- Patients whom recently (3-6 months before screening) received PCI and continuation of clopidogrel till the day of operation is advisable (according to the advice of the cardiologist)
- Patients who refuse to accept medically- indicated blood products
- Pregnancy and breast feeding
- Patients who received investigational drugs in the previous 30 days, or are currently participating in a study during which the administration of investigational drugs within one month is anticipated
About this study
Official title: Effect of Clopidogrel (Plavix) on Postoperative Bleeding in Patients Undergoing Coronary Artery Bypass Surgery. A Prospective Randomized Controlled Study
- Running title: Effect of Clopidogrel on Postoperative Bleeding in Patients undergoing Coronary Artery Bypass Surgery
- Title: Clopidogrel and bleeding in patients undergoing coronary artery bypass grafting. Is surgical delay necessary in patients using clopidogrel? And if so, which is the safety time interval when clopidogrel should be stopped before surgery in order to avoid bleeding and other related complications.
- Background: By blockade of the platelet ADP receptor, clopidogrel inhibits the binding of fibrinogen to the platelet GPIIb/IIIa receptor complex, thereby preventing platelet aggregation from ADP stimulation. Some authors suggest that the platelet function is completely recovered in 7 days after stopping clopidogrel in healthy subjects. Other researches suggest full recovery of platelet function in 3 to 5 days.
- Study objectives: To investigate if the interruption of the clopidogrel is necessary before CABG in order to prevent bleeding and other complications.
To trace the increased risk patients for postoperative bleeding and to individualize the therapy according to TEG measurements.
Read more
- Design: A prospective, randomized mono- center study
- Patients: Patients who are receiving elective or urgent CABG surgery and are pre-treated at least 5 days before surgery with clopidogrel
- Primary endpoint: To determine if there are significant differences in blood loss, transfusions and rethoracotomies in the three selected groups of patients treated with clopidogrel To asses the predictive value of the TEG clot strength in postoperative bleeding in patients using Clopidogrel.
- Secondary endpoints: Death, myocardial infarction, stroke, respiratory failure, renal failure requiring dialysis, mediastinitis,readmission rates within 30 days from discharge, and ICU and hospital lengths of stay
- Risks: Using standard dose of aprotinin, we consider no increased risk in blood loss and other related complications for this three groups of patients.
- Possible benefits: Reduction of time delay in operating patients under treatment with clopidogrel.
A more accurate time interval when clopidogrel should be stopped before surgery in order to eliminate the risk of bleeding and associated complications.
- Conditions
- Coronary Artery Disease
- Being tested
- Clopidogrel
- Keywords
- coronary artery bypass grafting, clopidogrel, post-operative bleeding
- 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.
ClopidogrelDrug
Also called plavix
Clopidogrel is stopped 5 days prior to surgery
ClopidogrelDrug
Also called plavix
Clopidogrel is stopped 3 days prior to surgery
ClopidogrelDrug
Also called plavix
Clopidogrel is stopped 0 days prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Clopidogrel is stopped 5 days prior to surgery Receives: Drug: Clopidogrel |
| 2 | Experimental | Clopidogrel is stopped 3 days prior to surgery Receives: Drug: Clopidogrel |
| 3 | Experimental | Clopidogrel is stopped 0 days prior to surgery Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point of this study is to determine if there are significant differences in blood loss, transfusions and rethoracotomies in the three selected groups of patients treated with clopidogrel
Measured: within 30 days (+/- 5 days) after surgery
To asses the predictive value of the TEG clot strength in postoperative bleeding in patients using clopidogrel
Measured: within 30 days (+/- 5 days) after surgery
Secondary outcomes (9)
death
Measured: within 30 days (+/- 5 days) after surgery
myocardial infarction
Measured: within 30 days (+/- 5 days) after surgery
stroke
Measured: within 30 days (+/- 5 days) after surgery
respiratory failure
Measured: within 30 days (+/- 5 days) after surgery
renal failure requiring dialysis
Measured: within 30 days (+/- 5 days) after surgery
mediastinitis
Measured: within 30 days (+/- 5 days) after surgery
wound infection
Measured: within 30 days (+/- 5 days) after surgery
readmission rates within 30 days from discharge
Measured: within 30 days (+/- 5 days) after surgery
ICU and hospital lengths of stay.
Measured: within 30 days (+/- 5 days) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startJun 2006
- Primary completionNov 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Investigators
- A.H.M. van Straten, MD, Principal investigator, Catharina hospital, department of Cardio Thoracic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724880
- Sponsor's protocol ID
- Plavix studie
- Status last verified
- Jul 2008
- First submitted
- 28 Jul 2008
- Last updated
- 30 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Clopidogrel (Plavix) on Postoperative Bleeding in Patients Undergoing Coronary Artery Bypass Surgery. A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00724880
- Acronym / sponsor ID
- Plavix studie
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery bypass grafting, clopidogrel, post-operative bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 30 Jul 2008 (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.
- Running title: Effect of Clopidogrel on Postoperative Bleeding in Patients undergoing Coronary Artery Bypass Surgery
- Title: Clopidogrel and bleeding in patients undergoing coronary artery bypass grafting. Is surgical delay necessary in patients using clopidogrel? And if so, which is the safety time interval when clopidogrel should be stopped before surgery in order to avoid bleeding and other related complications.
- Background: By blockade of the platelet ADP receptor, clopidogrel inhibits the binding of fibrinogen to the platelet GPIIb/IIIa receptor complex, thereby preventing platelet aggregation from ADP stimulation. Some authors suggest that the platelet function is completely recovered in 7 days after stopping clopidogrel in healthy subjects. Other researches suggest full recovery of platelet function in 3 to 5 days.
- Study objectives: To investigate if the interruption of the clopidogrel is necessary before CABG in order to prevent bleeding and other complications.
To trace the increased risk patients for postoperative bleeding and to individualize the therapy according to TEG measurements.
- Design: A prospective, randomized mono- center study
- Patients: Patients who are receiving elective or urgent CABG surgery and are pre-treated at least 5 days before surgery with clopidogrel
- Primary endpoint: To determine if there are significant differences in blood loss, transfusions and rethoracotomies in the three selected groups of patients treated with clopidogrel To asses the predictive value of the TEG clot strength in postoperative bleeding in patients using Clopidogrel.
- Secondary endpoints: Death, myocardial infarction, stroke, respiratory failure, renal failure requiring dialysis, mediastinitis,readmission rates within 30 days from discharge, and ICU and hospital lengths of stay
- Risks: Using standard dose of aprotinin, we consider no increased risk in blood loss and other related complications for this three groups of patients.
- Possible benefits: Reduction of time delay in operating patients under treatment with clopidogrel.
A more accurate time interval when clopidogrel should be stopped before surgery in order to eliminate the risk of bleeding and associated complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ClopidogrelClopidogrel is stopped 5 days prior to surgery |
| 2 | Experimental | Drug: ClopidogrelClopidogrel is stopped 3 days prior to surgery |
| 3 | Experimental | Drug: ClopidogrelClopidogrel is stopped 0 days prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are using clopidogrel at least 5 days before surgery with a dose of 75 mg clopidogrel without loading dose with or without concomitant use of aspirin.
- Patients who received a loading dose of 300-600 mg clopidogrel 24 hours before CABG, with or without concomitant use of aspirin
- Patients approved for elective or urgent CABG surgery
Key exclusion criteria (15 listed)
- Patients who are concomitant using oral coumarin derivates, heparine derivates iv., dipiridamol or other anticoagulant treatment, 5 days before operation.
- Patients with pre-existing bleeding disorders, thrombocytopenia
- Patients who have renal insufficiency (creatinine >2.0 mg/dL) or chronic renal failure requiring dialysis
- Patients in end stage heart failure
- Patients who have evidence of significant hepatic disease including clinical signs or laboratory values of total bilirubin> 2.0 mg/dL, ALAT or ASAT> 3X upper limit of normal, or INR >2X upper limit of normal (not due to anticoagulation therapy)
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 |
|---|---|---|
| ClopidogrelAlso: plavixClopidogrel is stopped 5 days prior to surgery | Drug | 1 |
| ClopidogrelAlso: plavixClopidogrel is stopped 3 days prior to surgery | Drug | 2 |
| ClopidogrelAlso: plavixClopidogrel is stopped 0 days prior to surgery | Drug | 3 |
Primary outcome
The primary end point of this study is to determine if there are significant differences in blood loss, transfusions and rethoracotomies in the three selected groups of patients treated with clopidogrel
Time frame: within 30 days (+/- 5 days) after surgery
To asses the predictive value of the TEG clot strength in postoperative bleeding in patients using clopidogrel
Time frame: within 30 days (+/- 5 days) after surgery
9 secondary outcomes
death
Time frame: within 30 days (+/- 5 days) after surgery
myocardial infarction
Time frame: within 30 days (+/- 5 days) after surgery
stroke
Time frame: within 30 days (+/- 5 days) after surgery
respiratory failure
Time frame: within 30 days (+/- 5 days) after surgery
renal failure requiring dialysis
Time frame: within 30 days (+/- 5 days) after surgery
mediastinitis
Time frame: within 30 days (+/- 5 days) after surgery
wound infection
Time frame: within 30 days (+/- 5 days) after surgery
readmission rates within 30 days from discharge
Time frame: within 30 days (+/- 5 days) after surgery
ICU and hospital lengths of stay.
Time frame: within 30 days (+/- 5 days) after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2008.
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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.
A.H.M. van Straten, MD principal investigator
Catharina hospital, department of Cardio Thoracic Surgery
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopidogrel in people with Coronary Artery Disease, run by Catharina Ziekenhuis Eindhoven.
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 15 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: finished, as of the sponsor's last update on 30 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end point of this study is to determine if there are significant differences in blood loss, transfusions and rethoracotomies in the three selected groups of patients treated with clopidogrel (time frame: within 30 days (+/- 5 days) after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2008.