Study of Optimal Clopidogrel Duration in Patients Receiving Drug Eluting Stents (SCORE Trial)
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 9/15/2018 |
| Start Date: | September 11, 2008 |
| End Date: | March 3, 2014 |
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.
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.
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.
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.
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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