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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Clopidogrel
Sponsored by
North Texas Veterans Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Drug Eluting Stent, Clopidogrel, Optimal duration of clopidogrel post DES stent implantation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dallas Veterans Hospital
  • The Onassis cardiac Surgery Centre
  • Escorts Health Institute & Research Centre Ltd

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Death and Myocardial Infarction

Secondary Outcome Measures

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

Full Information

First Posted
October 28, 2008
Last Updated
September 11, 2018
Sponsor
North Texas Veterans Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT00781573
Brief Title
Study of Optimal Clopidogrel Duration in Patients Receiving Drug Eluting Stents (SCORE Trial)
Acronym
SCORE
Official Title
Study of Optimal Clopidogrel Duration in Patients Receiving Drug Eluting Stents (SCORE Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 11, 2008 (Actual)
Primary Completion Date
March 3, 2014 (Actual)
Study Completion Date
March 3, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North Texas Veterans Healthcare System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: Death / Myocardial infarction (MI) (Primary end-point) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Drug Eluting Stent, Clopidogrel, Optimal duration of clopidogrel post DES stent implantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Clopidogrel (75 mg/day) is continued for another year at the completion of the initial year of clopidogrel and aspirin administration post DES implantation
Arm Title
2
Arm Type
No Intervention
Arm Description
Clopidogrel (75 mg/day) is stopped at the completion of the initial year of clopidogrel and aspirin administration post DES implantation
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
Clopidogrel, 75 mg QD, for one year
Primary Outcome Measure Information:
Title
Death and Myocardial Infarction
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Combined endpoints of death, myocardial infarction, repeat revascularization, stroke and major/minor bleeding
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Subhash Banerjee, MD
Organizational Affiliation
VA North Texas Healthcare System, UT Southwestern Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emmanouil S Brilakis, MD, PhD
Organizational Affiliation
VA North Texas Healthcare System, Dallas, TX
Official's Role
Study Director
Facility Information:
Facility Name
Dallas Veterans Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
The Onassis cardiac Surgery Centre
City
Athens
Country
Greece
Facility Name
Escorts Health Institute & Research Centre Ltd
City
New Delhi
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
18940284
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.
Results Reference
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PubMed Identifier
18252883
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.
Results Reference
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Study of Optimal Clopidogrel Duration in Patients Receiving Drug Eluting Stents (SCORE Trial)

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