View Clinical Trial (Medical Research Study)
Study of Optimal Clopidogrel Duration in Patients Receiving Drug Eluting Stents (SCORE Trial)
| City: |
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Dallas |
| State: |
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Texas |
| Zip Code: |
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75216 |
| Conditions: |
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Myocardial Infarction |
| Purpose: |
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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. The investigators 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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- Post-PCI patients receiving at least 1 DES
- Completed 9-15 months 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
- Patients with a life expectancy less than 1 year due to active cancers (except basal
cell carcinoma)
- Pregnancy
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| NCT ID: |
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NCT00781573 |
| Primary Contact: |
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Principal Investigator
Subhash Banerjee, MD
VA North Texas Healthcare System, UT Southwestern Medical Center
Subhash Banerjee, MD
Phone: (214)857-1608
Email: subhash.banerjee@va.gov
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| Backup Contact: |
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Email: Preeti.Kamath@va.gov
Preeti Kamath
Phone: 214-857-0305
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| Location Contact: |
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Dallas, Texas 75216
United States
Subhash Banerjee, MD
Phone: 214-857-1608
Email: subhash.banerjee@va.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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