NCT00370045

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2006

Completed
Last Updated

August 30, 2006

Status Verified

August 1, 2006

First QC Date

August 28, 2006

Last Update Submit

August 29, 2006

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

Bivalirudin with and without eptifibatideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinai Hospital

Baltimore, Maryland, 21215, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 23392654DERIVED

  • Shuldiner 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.

    PMID: 19706858DERIVED

  • Gurbel 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.

    PMID: 19232896DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

bivalirudinEptifibatide

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Paul A Gurbel, MD

    Platelet and Thrombosis Research L.L.C

    PRINCIPAL INVESTIGATOR

Central Study Contacts

kevin p bliden, BS

CONTACT

4106014795kbliden@lifebridgehealth.org

joe Dichiara, BS

CONTACT

4106010619jdichiar@lifebridgehealth.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 28, 2006

First Posted

August 30, 2006

Study Start

March 1, 2006

Last Updated

August 30, 2006

Record last verified: 2006-08

Locations

US(1)