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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 2 | No Intervention | Clopidogrel (75 mg/day) is stopped at the completion of the initial year of clopidogrel and aspirin administration post DES implantation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel | Drug | Clopidogrel, 75 mg QD, for one year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death and Myocardial Infarction | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Combined endpoints of death, myocardial infarction, repeat revascularization, stroke and major/minor bleeding | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Subhash Banerjee, MD | VA North Texas Healthcare System, UT Southwestern Medical Center | Principal Investigator |
| Emmanouil S Brilakis, MD, PhD | VA North Texas Healthcare System, Dallas, TX | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dallas Veterans Hospital | Dallas | Texas | 75216 | United States | ||
| The Onassis cardiac Surgery Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18940284 | Background | Banerjee S, Varghese C, Samuel J, Weideman RA, Little BB, Kelly KC, Rao SV, Reilly RF, Brilakis ES. Comparison of the impact of short (<1 year) and long-term (> or =1 year) clopidogrel use following percutaneous coronary intervention on mortality. Am J Cardiol. 2008 Nov 1;102(9):1159-62. doi: 10.1016/j.amjcard.2008.06.058. Epub 2008 Sep 11. | |
| 18252883 |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Athens |
| Greece |
| Escorts Health Institute & Research Centre Ltd | New Delhi | India |
| Ho PM, Peterson ED, Wang L, Magid DJ, Fihn SD, Larsen GC, Jesse RA, Rumsfeld JS. Incidence of death and acute myocardial infarction associated with stopping clopidogrel after acute coronary syndrome. JAMA. 2008 Feb 6;299(5):532-9. doi: 10.1001/jama.299.5.532. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |