Study of Optimal Clopidogrel Duration in Patients Receiving Drug Eluting Stents (SCORE Trial)

Myocardial Infarction Clinical Trial

— SCORE  

Official title:

Study of Optimal Clopidogrel Duration in Patients Receiving Drug Eluting Stents (SCORE Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781573
• Other study ID #: Dallas VA IRB #08-048
• Status: Completed
• Phase: N/A
• Start date: September 11, 2008
• Est. completion date: March 3, 2014

Study information

• Verified date: September 2018
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: March 3, 2014
• Est. primary completion date: March 3, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Clopidogrel
Clopidogrel, 75 mg QD, for one year

Locations

Country	Name	City	State
Greece	The Onassis cardiac Surgery Centre	Athens
India	Escorts Health Institute & Research Centre Ltd	New Delhi
United States	Dallas Veterans Hospital	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
North Texas Veterans Healthcare System

Countries where clinical trial is conducted

United States,  Greece,  India, 

References & Publications (2)

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. — View 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. Erratum in: JAMA. 2008 May 28;299(20):2390. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death and Myocardial Infarction		12 months
Secondary	Combined endpoints of death, myocardial infarction, repeat revascularization, stroke and major/minor bleeding		12 months