Coronary Artery DiseasePhase 4NCT00370045
Peri-Procedural Myocardial Infarction, Platelet Reactivity, Thrombin Generation, and Clot Strength: Differential Effects of Eptifibatide + Bivalirudin Versus Bivalirudin
A Phase 4 study testing Bivalirudin with and without eptifibatide in people with Coronary Artery Disease, run by LifeBridge Health at 1 site in United States.
Trial summary
The purpose of this study is to compare levels of clot formation (platelet aggregation), markers of heart muscle damage, and inflammation in two groups undergoing percutaneous coronary stent implantation. 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?
- Bivalirudin with and without eptifibatide
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to not given
- 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
- Subjects (men or women) aged ³ 18
- Patients undergoing elective coronary stenting (200 patients)
Who cannot join
- ST-segment elevation myocardial infarction within 48 hours prior to randomization
- Prior PCI within previous 4 weeks of randomization or planned staged PCI within the subsequent month.
- Cardiogenic shock
- > 50% unprotected left main stenosis
- Any low molecular weight heparin within the prior 12 hours
- Treatment with any P2Y12 blocker (Plavix or Ticlid) within the previous 14 days before randomization
Show all 19Show fewer
- Treatment with any platelet GPIIb/IIIa inhibitor within the previous 30 days before randomization
- Concurrent treatment with warfarin
- History of bleeding diathesis, or evidence of active abnormal bleeding within 30 days of randomization.
- History of hemorrhagic stroke at any time, or stroke or TIA of any etiology within 30 days of randomization.
- Major surgery within 6 weeks prior to randomization.
- Known platelet count of <100,000/mm3.
- PT > 1.5 X control
- HCT < 25%
- Known allergy or contraindication to eptifibatide, heparin, aspirin or plavix.
- Participation in a study of experimental therapy or device 30 days prior to randomization.
- Creatinine level of greater than 2.0 mg/dl or a creatinine clearance <30mL
- Known history of alcohol or drug abuse
- Pregnant women or women of child bearing potential not using an acceptable method of contraception.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sinai Hospital
Baltimore, Maryland, 21215
Kevin P Bliden, BS, 410-601-4795, kbliden@lifebridgehealth.org
Paul A Gurbel, MD
About this study
Official title: Peri-Procedural Myocardial Infarction, Platelet Reactivity, Thrombin Generation, and Clot Strength: Differential Effects of Eptifibatide + Bivalirudin Versus Bivalirudin -The CLEAR PLATELETS-2 Study
The purpose of this study is to compare levels of clot formation (platelet aggregation), markers of heart muscle damage, and inflammation in two groups undergoing percutaneous coronary stent implantation. The first group will be on a regimen of high-dose clopidogrel used in combination with bivalirudin plus eptifibatide, and the second group will be on a regimen of high-dose clopidogrel with bivalirudin alone. Clinical outcomes will be determined up to one year after enrollment.
Read the detailed description
Percutaneous stent implantation has revolutionized the revascularization procedure for patients with obstructive coronary disease and angina. The major risk of coronary stenting, both during and after the procedure, is clot formation (thrombosis) which often leads to significant heart muscle damage. The standard medical practice for patients undergoing coronary stenting is the use of antiplatelet (plavix, aspirin) and anticoagulant (blood thinner) therapy. The results from our recently completed CLEAR PLATELETS I study showed that the addition of eptifibatide (a potent antiplatelet agent) to current therapy resulted in superior reduction in clot formation, inflammation and heart damage after elective coronary intervention. Recent studies have also suggested the drug bivalirudin to be a safer and more effective therapy compared to heparin, the current anticoagulant agent of choice. It has been hypothesized that bivalirudin acts not only as an anticoagulant but also as an antiplatelet agent, making the use of eptifibatide in current coronary therapy unwarranted. In the CLEAR PLATELET II study, we will compare levels of clot formation (platelet aggregation), markers of heart muscle damage, and inflammation in two groups. The first group will be on a regimen of high-dose clopidogrel used in combination with bivalirudin plus eptifibatide, and the second group will be on a regimen of high-dose clopidogrel with bivalirudin alone. The antiplatelet/antithrombotic effect that bivalirudin has in combination with these current therapies is unknown; therefore we hope to see the effect that bivalirudin has on arresting platelet formation with and without eptifibatide.
This research will be done at Sinai Hospital of Baltimore with Paul Gurbel M.D. as the principal investigator. It will include 200 patients who will be randomized equally between groups.
Clopidogrel (600 mg) + eptifibatide + bivalirudin Clopidogrel (600 mg) + bivalirudin
All patients will receive treatment with clopidogrel in the cath lab immediately after successful stenting. All patients post-stenting will receive standard antiplatelet treatment (75mg Plavix and 325 mg aspirin). Patients will have serial assessment of platelet reactivity, myocardial necrosis markers, and inflammatory markers (3 tablespoons of blood per time point) at baseline, 2 hours, 8 hours, and 18- 24 hours post-stenting. All blood work will be processed at the Sinai Center for Thrombosis Research. Clinical outcomes will be recorded using a standard case report form. Patients will be followed up at 30 days and 1 year by telephone to assess for adverse events.
- Conditions
- Coronary Artery Disease
- Being tested
- Bivalirudin with and without eptifibatide
- 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.
Bivalirudin with and without eptifibatideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the antiplatelet effects of clopidogrel+bivalirudin vs. clopidogrel+bivalirudin+eptifibatide in patients undergoing elective percutaneous intervention
Secondary outcomes (3)
Compare the release of myocardial necrosis and inflammatory markers
Measure platelet reactivity with conventional light transmittance aggregometry and thrombelastography
Assess in-hospital 30 day, and 1 year clinical outcomes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2006 (estimated)
- Study startMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- LifeBridge Health
- Sponsor type
- University, hospital or other
- Investigators
- Paul A Gurbel, MD, Principal investigator, Platelet and Thrombosis Research L.L.C
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370045
- Sponsor's protocol ID
- P04745
- Status last verified
- Aug 2006
- First submitted
- 28 Aug 2006
- Last updated
- 30 Aug 2006
- Results posted
- No
Publications
Lewis JP, Ryan K, O'Connell JR, Horenstein RB, Damcott CM, Gibson Q, Pollin TI, Mitchell BD, Beitelshees AL, Pakzy R, Tanner K, Parsa A, Tantry US, Bliden KP, Post WS, Faraday N, Herzog W, Gong Y, Pepine CJ, Johnson JA, Gurbel PA, Shuldiner AR. Genetic variation in PEAR1 is associated with platelet aggregation and cardiovascular outcomes. Circ Cardiovasc Genet. 2013 Apr;6(2):184-92. doi: 10.1161/CIRCGENETICS.111.964627. Epub 2013 Feb 7.
PubMed 23392654Shuldiner AR, O'Connell JR, Bliden KP, Gandhi A, Ryan K, Horenstein RB, Damcott CM, Pakyz R, Tantry US, Gibson Q, Pollin TI, Post W, Parsa A, Mitchell BD, Faraday N, Herzog W, Gurbel PA. Association of cytochrome P450 2C19 genotype with the antiplatelet effect and clinical efficacy of clopidogrel therapy. JAMA. 2009 Aug 26;302(8):849-57. doi: 10.1001/jama.2009.1232.
PubMed 19706858Gurbel PA, Bliden KP, Saucedo JF, Suarez TA, DiChiara J, Antonino MJ, Mahla E, Singla A, Herzog WR, Bassi AK, Hennebry TA, Gesheff TB, Tantry US. Bivalirudin and clopidogrel with and without eptifibatide for elective stenting: effects on platelet function, thrombelastographic indexes, and their relation to periprocedural infarction results of the CLEAR PLATELETS-2 (Clopidogrel with Eptifibatide to Arrest the Reactivity of Platelets) study. J Am Coll Cardiol. 2009 Feb 24;53(8):648-57. doi: 10.1016/j.jacc.2008.10.045.
PubMed 19232896
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-Procedural Myocardial Infarction, Platelet Reactivity, Thrombin Generation, and Clot Strength: Differential Effects of Eptifibatide + Bivalirudin Versus Bivalirudin -The CLEAR PLATELETS-2 Study
- ClinicalTrials.gov ID
- NCT00370045
- Acronym / sponsor ID
- P04745
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- LifeBridge HealthUniversity, hospital or other
- Study start
- Mar 2006
- First posted
- 30 Aug 2006 (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 compare levels of clot formation (platelet aggregation), markers of heart muscle damage, and inflammation in two groups undergoing percutaneous coronary stent implantation. The first group will be on a regimen of high-dose clopidogrel used in combination with bivalirudin plus eptifibatide, and the second group will be on a regimen of high-dose clopidogrel with bivalirudin alone. Clinical outcomes will be determined up to one year after enrollment.
Detailed description
Percutaneous stent implantation has revolutionized the revascularization procedure for patients with obstructive coronary disease and angina. The major risk of coronary stenting, both during and after the procedure, is clot formation (thrombosis) which often leads to significant heart muscle damage. The standard medical practice for patients undergoing coronary stenting is the use of antiplatelet (plavix, aspirin) and anticoagulant (blood thinner) therapy. The results from our recently completed CLEAR PLATELETS I study showed that the addition of eptifibatide (a potent antiplatelet agent) to current therapy resulted in superior reduction in clot formation, inflammation and heart damage after elective coronary intervention. Recent studies have also suggested the drug bivalirudin to be a safer and more effective therapy compared to heparin, the current anticoagulant agent of choice. It has been hypothesized that bivalirudin acts not only as an anticoagulant but also as an antiplatelet agent, making the use of eptifibatide in current coronary therapy unwarranted. In the CLEAR PLATELET II study, we will compare levels of clot formation (platelet aggregation), markers of heart muscle damage, and inflammation in two groups. The first group will be on a regimen of high-dose clopidogrel used in combination with bivalirudin plus eptifibatide, and the second group will be on a regimen of high-dose clopidogrel with bivalirudin alone. The antiplatelet/antithrombotic effect that bivalirudin has in combination with these current therapies is unknown; therefore we hope to see the effect that bivalirudin has on arresting platelet formation with and without eptifibatide.
This research will be done at Sinai Hospital of Baltimore with Paul Gurbel M.D. as the principal investigator. It will include 200 patients who will be randomized equally between groups.
Clopidogrel (600 mg) + eptifibatide + bivalirudin Clopidogrel (600 mg) + bivalirudin
All patients will receive treatment with clopidogrel in the cath lab immediately after successful stenting. All patients post-stenting will receive standard antiplatelet treatment (75mg Plavix and 325 mg aspirin). Patients will have serial assessment of platelet reactivity, myocardial necrosis markers, and inflammatory markers (3 tablespoons of blood per time point) at baseline, 2 hours, 8 hours, and 18- 24 hours post-stenting. All blood work will be processed at the Sinai Center for Thrombosis Research. Clinical outcomes will be recorded using a standard case report form. Patients will be followed up at 30 days and 1 year by telephone to assess for adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects (men or women) aged ³ 18
- Patients undergoing elective coronary stenting (200 patients)
Key exclusion criteria (19 listed)
- ST-segment elevation myocardial infarction within 48 hours prior to randomization
- Prior PCI within previous 4 weeks of randomization or planned staged PCI within the subsequent month.
- Cardiogenic shock
- > 50% unprotected left main stenosis
- Any low molecular weight heparin within the prior 12 hours
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 |
|---|---|---|
| Bivalirudin with and without eptifibatide | Drug | – |
Primary outcome
Compare the antiplatelet effects of clopidogrel+bivalirudin vs. clopidogrel+bivalirudin+eptifibatide in patients undergoing elective percutaneous intervention
3 secondary outcomes
Compare the release of myocardial necrosis and inflammatory markers
Measure platelet reactivity with conventional light transmittance aggregometry and thrombelastography
Assess in-hospital 30 day, and 1 year clinical outcomes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2006.
- Derived from this study: PubMed 23392654Lewis JP, Ryan K, O'Connell JR, Horenstein RB, Damcott CM, Gibson Q, Pollin TI, Mitchell BD, Beitelshees AL, Pakzy R, Tanner K, Parsa A, Tantry US, Bliden KP, Post WS, Faraday N, Herzog W, Gong Y, Pepine CJ, Johnson JA, Gurbel PA, Shuldiner AR. Genetic variation in PEAR1 is associated with platelet aggregation and cardiovascular outcomes. Circ Cardiovasc Genet. 2013 Apr;6(2):184-92. doi: 10.1161/CIRCGENETICS.111.964627. Epub 2013 Feb 7.
- Derived from this study: PubMed 19706858Shuldiner AR, O'Connell JR, Bliden KP, Gandhi A, Ryan K, Horenstein RB, Damcott CM, Pakyz R, Tantry US, Gibson Q, Pollin TI, Post W, Parsa A, Mitchell BD, Faraday N, Herzog W, Gurbel PA. Association of cytochrome P450 2C19 genotype with the antiplatelet effect and clinical efficacy of clopidogrel therapy. JAMA. 2009 Aug 26;302(8):849-57. doi: 10.1001/jama.2009.1232.
- Derived from this study: PubMed 19232896Gurbel PA, Bliden KP, Saucedo JF, Suarez TA, DiChiara J, Antonino MJ, Mahla E, Singla A, Herzog WR, Bassi AK, Hennebry TA, Gesheff TB, Tantry US. Bivalirudin and clopidogrel with and without eptifibatide for elective stenting: effects on platelet function, thrombelastographic indexes, and their relation to periprocedural infarction results of the CLEAR PLATELETS-2 (Clopidogrel with Eptifibatide to Arrest the Reactivity of Platelets) study. J Am Coll Cardiol. 2009 Feb 24;53(8):648-57. doi: 10.1016/j.jacc.2008.10.045.
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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.
Paul A Gurbel, MD principal investigator
Platelet and Thrombosis Research L.L.C
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bivalirudin with and without eptifibatide 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 2 inclusion and 19 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 30 Aug 2006. 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.
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?
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?
Compare the antiplatelet effects of clopidogrel+bivalirudin vs. clopidogrel+bivalirudin+eptifibatide in patients undergoing elective percutaneous intervention. 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 NCT00370045, which also lists 3 linked publications.
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 Aug 2006.