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

September 11, 2018 updated by: Subhash Banerjee, North Texas Veterans Healthcare System
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • The Onassis cardiac Surgery Centre
  • India
      • New Delhi, India
        • Escorts Health Institute & Research Centre Ltd
  • United States
    • Texas
      • Dallas, Texas, United States, 75216
        • Dallas Veterans Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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
Clopidogrel, 75 mg QD, for one year
No Intervention: 2
Clopidogrel (75 mg/day) is stopped at the completion of the initial year of clopidogrel and aspirin administration post DES implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death and Myocardial Infarction
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Combined endpoints of death, myocardial infarction, repeat revascularization, stroke and major/minor bleeding
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Texas Veterans Healthcare System

Investigators

  • Principal Investigator: Subhash Banerjee, MD, VA North Texas Healthcare System, UT Southwestern Medical Center
  • Study Director: Emmanouil S Brilakis, MD, PhD, VA North Texas Healthcare System, Dallas, TX

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2008

Primary Completion (Actual)

March 3, 2014

Study Completion (Actual)

March 3, 2014

Study Registration Dates

First Submitted

October 28, 2008

First Submitted That Met QC Criteria

October 28, 2008

First Posted (Estimate)

October 29, 2008

Study Record Updates

Last Update Posted (Actual)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dallas VA IRB #08-048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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