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

NCT00781573 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2018-09-13

No results posted yet for this study

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

Interventions

DRUG

Clopidogrel

Clopidogrel, 75 mg QD, for one year

Sponsors & Collaborators

  • North Texas Veterans Healthcare System

    lead FED

Principal Investigators

  • Subhash Banerjee, MD · VA North Texas Healthcare System, UT Southwestern Medical Center

  • Emmanouil S Brilakis, MD, PhD · VA North Texas Healthcare System, Dallas, TX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-11
Primary Completion
2014-03-03
Completion
2014-03-03

Countries

  • United States
  • Greece
  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00781573 on ClinicalTrials.gov