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Sponsored by: |
Dallas VA Medical Center |
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Information provided by: | North Texas Veterans' Healthcare System |
ClinicalTrials.gov Identifier: | NCT00781573 |
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 |
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Myocardial Infarction |
Drug: Clopidogrel |
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) |
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 |
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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
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Drug: Clopidogrel
Clopidogrel, 75 mg QD, for one year
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2: No Intervention
Clopidogrel (75 mg/day) is stopped at the completion of the initial year of clopidogrel and aspirin administration post DES implantation
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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:
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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Subhash Banerjee, MD | (214)857-1608 | subhash.banerjee@va.gov |
Contact: Cyril Varghese, BS | zcman84@yahoo.com |
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 |
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 |
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 |
Drug Eluting Stent Clopidogrel Optimal duration of clopidogrel post DES stent implantation |
Necrosis Heart Diseases Clopidogrel Myocardial Ischemia |
Vascular Diseases Ischemia Infarction Myocardial Infarction |
Pathologic Processes Therapeutic Uses Hematologic Agents |
Platelet Aggregation Inhibitors Cardiovascular Diseases Pharmacologic Actions |