Peri-Procedural Myocardial Infarction, Platelet Reactivity, Thrombin Generation, and Clot Strength: Differential Effects of Eptifibatide + Bivalirudin Versus Bivalirudin

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by LifeBridge Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
LifeBridge Health
ClinicalTrials.gov Identifier:
NCT00370045
First received: August 28, 2006
Last updated: August 29, 2006
Last verified: August 2006
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Drug: Bivalirudin with and without eptifibatide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

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Further study details as provided by LifeBridge Health:

Primary Outcome Measures:
  • Compare the antiplatelet effects of clopidogrel+bivalirudin vs. clopidogrel+bivalirudin+eptifibatide in patients undergoing elective percutaneous intervention

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 200
Study Start Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects (men or women) aged ³ 18
  • Patients undergoing elective coronary stenting (200 patients)

Exclusion Criteria:

  • 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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370045

Contacts
Contact: kevin p bliden, BS 4106014795 kbliden@lifebridgehealth.org
Contact: joe Dichiara, BS 4106010619 jdichiar@lifebridgehealth.org

Locations
United States, Maryland
Sinai Hospital Recruiting
Baltimore, Maryland, United States, 21215
Contact: Kevin P Bliden, BS    410-601-4795    kbliden@lifebridgehealth.org   
Principal Investigator: Paul A Gurbel, MD         
Sub-Investigator: William Herzog, MD         
Sub-Investigator: Charles Cummings, MD         
Sub-Investigator: Ashwani Bassi, MD         
Sub-Investigator: Benjamin Dubois, MD         
Sponsors and Collaborators
LifeBridge Health
Investigators
Principal Investigator: Paul A Gurbel, MD Platelet and Thrombosis Research L.L.C
  More Information

No publications provided by LifeBridge Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00370045     History of Changes
Other Study ID Numbers: P04745
Study First Received: August 28, 2006
Last Updated: August 29, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Bivalirudin
Hirudins
Eptifibatide
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014