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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Subhash Banerjee, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT00781573
First received: October 28, 2008
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Myocardial Infarction
Drug: Clopidogrel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Optimal Clopidogrel Duration in Patients Receiving Drug Eluting Stents (SCORE Trial)

Resource links provided by NLM:


Further study details as provided by North Texas Veterans Healthcare System:

Primary Outcome Measures:
  • Death and Myocardial Infarction [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Combined endpoints of death, myocardial infarction, repeat revascularization, stroke and major/minor bleeding [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 280
Study Start Date: September 2008
Estimated Study Completion Date: March 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Clopidogrel
No Intervention: 2
Clopidogrel (75 mg/day) is stopped at the completion of the initial year of clopidogrel and aspirin administration post DES implantation

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781573

Locations
United States, Texas
Dallas Veterans Hospital
Dallas, Texas, United States, 75216
Greece
The Onassis cardiac Surgery Centre
Athens, Greece
India
Escorts Health Institute & Research Centre Ltd
New Delhi, India
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Subhash Banerjee, Acting chief of Cardiology, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT00781573     History of Changes
Other Study ID Numbers: Dallas VA IRB #08-048
Study First Received: October 28, 2008
Last Updated: November 1, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by North Texas Veterans Healthcare System:
Drug Eluting Stent
Clopidogrel
Optimal duration of clopidogrel post DES stent implantation

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 22, 2014