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Study of Optimal Clopidogrel Duration in Patients Receiving Drug Eluting Stents (SCORE Trial)
This study is currently recruiting participants.
Verified by North Texas Veterans' Healthcare System, September 2008
Sponsored by: Dallas VA Medical Center
Information provided by: North Texas Veterans' Healthcare System
ClinicalTrials.gov Identifier: NCT00781573
  Purpose

Although the optimal duration of clopidogrel (an anti-platelet agent) therapy has been established after bare metal stent implantation in the blood vessels of the heart, there is lack of consensus regarding the optimal duration of therapy after implantation of a drug eluting stents (DES). Current American College of Cardiology guidelines recommend clopidogrel use for at least one year in the absence of contraindications after DES implantation, while recognizing that the optimal duration remains unknown. While an extended clopidogrel therapy (that is beyond the current 1 year recommendation) may increase bleeding complication, it may reduce the rates of adverse cardiovascular events like heart attacks and repeat revascularization procedures. A clinical trial which randomizes patients with an uneventful one year course after a DES implantation, to an additional year of clopidogrel and aspirin therapy versus aspirin alone, will be able to answer the important question about the role of extended (2y) dual anti-platelet therapy with clopidogrel and aspirin after DES implants. We hypothesize that clopidogrel discontinuation at 1 year post-DES implantation is associated with an increase in cardiovascular events during the one year of follow-up period.


Condition Intervention
Myocardial Infarction
Drug: Clopidogrel

MedlinePlus related topics: Heart Attack
Drug Information available for: Clopidogrel Clopidogrel Bisulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: Study of Optimal Clopidogrel Duration in Patients Receiving Drug Eluting Stents (SCORE Trial)

Further study details as provided by North Texas Veterans' Healthcare System:

Primary Outcome Measures:
  • Death and Myocardial Infarction [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Combined endpoints of death, myocardial infarction, repeat revascularization, stroke and major/minor bleeding [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 280
Study Start Date: September 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Clopidogrel (75 mg/day) is continued for another year at the completion of the initial year of clopidogrel and aspirin administration post DES implantation
Drug: Clopidogrel
Clopidogrel, 75 mg QD, for one year
2: No Intervention
Clopidogrel (75 mg/day) is stopped at the completion of the initial year of clopidogrel and aspirin administration post DES implantation

Detailed Description:

SCORE is a multicenter, prospective randomized study of post-percutaneous coronary intervention (PCI) patients with an uneventful 1 year post-PCI course on dual anti-platelet therapy (DAPT) with clopidogrel and aspirin. Patient will be randomized to an additional 1 year of DAPT (treatment arm) vs. aspirin alone (control arm)to assess the following endpoints during the 1 year follow-up period:

  1. Death / Myocardial infarction (MI) (Primary end-point)
  2. Combined endpoints of death, myocardial infarction, repeat revascularization, stroke, and major/minor bleeding (Secondary end-point)

During the year of follow up, subjects will be contacted once every three months. This will enable us to track study endpoints in the study population. In addition the patients' medical records will be screened to investigate if any of the aforementioned endpoints have been reached.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Post-PCI patients receiving at least 1 DES
  • Completed 1 year follow-up free of MI, repeat revascularization
  • Able to provide informed consent
  • Have continued dual anti-platelet therapy with aspirin and clopidogrel for 1 year post-PCI

Exclusion Criteria:

  • Patients allergic to aspirin
  • Patients with aspirin resistance
  • Patients with allergy to clopidogrel
  • Patients on concomitant warfarin therapy
  • History of bleeding diathesis, coagulopathy, and/or platelet count < 100,000/ cubic mm
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781573

Contacts
Contact: Subhash Banerjee, MD (214)857-1608 subhash.banerjee@va.gov
Contact: Cyril Varghese, BS zcman84@yahoo.com

Locations
United States, Texas
Dallas Veterans Hospital Recruiting
Dallas, Texas, United States, 75216
Contact: Subhash Banerjee, MD     214-857-1608     subhash.banerjee@va.gov    
Contact: Cyril Varghese, BS         zcman84@yahoo.com    
Principal Investigator: Subhash Banerjee, MD            
Sub-Investigator: Emmanouil S Brilakis, MD, PhD            
Sponsors and Collaborators
Dallas VA Medical Center
Investigators
Principal Investigator: Subhash Banerjee, MD VA North Texas Healthcare System, UT Southwestern Medical Center
Study Director: Emmanouil S Brilakis, MD, PhD VA North Texas Healthcare System, Dallas, TX
  More Information

Publications:
Responsible Party: VA North Texas Healthcare System, Dallas, TX ( Dr. Subhash Banerjee, Acting chief of cardiology )
Study ID Numbers: Dallas VA IRB #08-048
Study First Received: October 28, 2008
Last Updated: October 28, 2008
ClinicalTrials.gov Identifier: NCT00781573  
Health Authority: United States: Federal Government

Keywords provided by North Texas Veterans' Healthcare System:
Drug Eluting Stent
Clopidogrel
Optimal duration of clopidogrel post DES stent implantation

Study placed in the following topic categories:
Necrosis
Heart Diseases
Clopidogrel
Myocardial Ischemia
Vascular Diseases
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:
Pathologic Processes
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009