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

NCT00781573 | Completed DMC

• 1 other identifier: Dallas VA IRB #08-048
• Study Type: interventional
• Target: 167
• Locations: 3 countries
• Sites: 3

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.

Conditions

Myocardial Infarction

Keywords

Drug Eluting Stent; Clopidogrel; Optimal duration of clopidogrel post DES stent implantation

Outcome Measures

Primary Outcomes (1)

• Death and Myocardial Infarction

  12 months

Secondary Outcomes (1)

• Combined endpoints of death, myocardial infarction, repeat revascularization, stroke and major/minor bleeding

  12 months

Study Arms (2)

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

Drug: Clopidogrel

2

NO INTERVENTION

Clopidogrel (75 mg/day) is stopped at the completion of the initial year of clopidogrel and aspirin administration post DES implantation

Interventions

Clopidogrel DRUG

Clopidogrel, 75 mg QD, for one year

1

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• North Texas Veterans Healthcare System: lead

Study Sites (3)

Dallas Veterans Hospital

Dallas, Texas, 75216, United States

Location

The Onassis cardiac Surgery Centre

Athens, Greece

Location

Escorts Health Institute & Research Centre Ltd

New Delhi, India

Location

Related 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.

  PMID: 18940284 BACKGROUND

• 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.

  PMID: 18252883 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting chief of Cardiology

Study Record Dates

• First Submitted: October 28, 2008
• First Posted: October 29, 2008
• Study Start: September 11, 2008
• Primary Completion: March 3, 2014
• Study Completion: March 3, 2014
• Last Updated: September 13, 2018

Record last verified: 2018-09

Locations

IN (1); US (1); GR (1)