Study of Optimal Clopidogrel Duration in Patients Receiving Drug Eluting Stents (SCORE Trial)
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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. 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.
| Condition | Intervention |
|---|---|
|
Myocardial Infarction |
Drug: Clopidogrel |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Study of Optimal Clopidogrel Duration in Patients Receiving Drug Eluting Stents (SCORE Trial) |
- Death and Myocardial Infarction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 |
|---|---|
|
Experimental: 1
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
Other Name: Clopidogrel
|
|
No Intervention: 2
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:
- Death / Myocardial infarction (MI) (Primary end-point)
- 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 |
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
Contacts and Locations| Contact: Subhash Banerjee, MD | (214)857-1608 | subhash.banerjee@va.gov |
| Contact: Preeti Kamath | 214-857-0305 | Preeti.Kamath@va.gov |
| United States, Texas | |
| Dallas Veterans Hospital | Recruiting |
| Dallas, Texas, United States, 75216 | |
| Contact: Subhash Banerjee, MD 214-857-1608 subhash.banerjee@va.gov | |
| Contact: Preeti Kamath 214-857-0305 Preeti.Kamath@va.gov | |
| Principal Investigator: Subhash Banerjee, MD | |
| Sub-Investigator: Emmanouil S Brilakis, MD, PhD | |
| Greece | |
| The Onassis cardiac Surgery Centre | Completed |
| Athens, Greece | |
| India | |
| Escorts Health Institute & Research Centre Ltd | Completed |
| New Delhi, India | |
| 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: | Dr. Subhash Banerjee, Acting chief of cardiology, VA North Texas Healthcare System, Dallas, TX |
| ClinicalTrials.gov Identifier: | NCT00781573 History of Changes |
| Other Study ID Numbers: | Dallas VA IRB #08-048 |
| Study First Received: | October 28, 2008 |
| Last Updated: | September 7, 2010 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by North Texas Veterans Healthcare System:
|
Drug Eluting Stent Clopidogrel Optimal duration of clopidogrel post DES stent implantation |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Myocardial Ischemia Heart Diseases Ischemia Pathologic Processes Necrosis Cardiovascular Diseases Vascular Diseases Clopidogrel Ticlopidine Platelet Aggregation Inhibitors Hematologic Agents |
Therapeutic Uses Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Fibrinolytic Agents Fibrin Modulating Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 21, 2013