Clinical trial NCT00781573: Study of Optimal Clopidogrel Duration in Patients Receiving Drug Eluting Stents (SCORE Trial)
Official title: Study of Optimal Clopidogrel Duration in Patients Receiving Drug Eluting Stents (SCORE Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: Drug Eluting Stent
Clopidogrel
Optimal duration of clopidogrel post DES stent implantation
Lead sponsor: North Texas Veterans Healthcare System
Sponsor class: FED
First posted: 2008-10-29
Enrollment: 167
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Death and Myocardial Infarction
timeFrame: 12 months
Secondary outcomes:
measure: Combined endpoints of death, myocardial infarction, repeat revascularization, stroke and major/minor bleeding
timeFrame: 12 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas Veterans Hospital
state: Texas
city: Athens
country: Greece
facility: The Onassis cardiac Surgery Centre
city: New Delhi
country: India
facility: Escorts Health Institute & Research Centre Ltd
Study officials:
affiliation: VA North Texas Healthcare System, UT Southwestern Medical Center
name: Subhash Banerjee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA North Texas Healthcare System, Dallas, TX
name: Emmanouil S Brilakis, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.