Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Patients Undergoing Percutaneous Coronary Intervention (PCI) Through Optimal Platelet Inhibition (TRIAGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01582217
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : December 23, 2015
Sponsor:
Collaborators:
Daiichi Sankyo, Inc.
Accumetrics, Inc.
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date April 18, 2012
First Posted Date April 20, 2012
Last Update Posted Date December 23, 2015
Study Start Date March 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2012)
MACE [ Time Frame: 12 months ]
Major adverse cardiac events (all-cause death, myocardial infarction and stent thrombosis)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 18, 2012)
Rates of major bleeding [ Time Frame: 12 months ]
The rates of major bleeding in patients treated with a thienopyridine based on the clinical algorithm.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Patients Undergoing Percutaneous Coronary Intervention (PCI) Through Optimal Platelet Inhibition
Official Title TRIAGE: Patients Undergoing Percutaneous Coronary Interventions to Improve Clinical Outcomes Through Optimal Platelet Inhibition
Brief Summary The purpose of this study is to assess the the 1-year rates of ischemic and bleeding complications in patients whose dual antiplatelet therapy regimen post-PCI has been determined with the use of a clinical algorithm that includes both clinical risks and platelet reactivity while on chronic clopidogrel therapy.
Detailed Description Prospective multicenter registry. Patients already on chronic dual antiplatelet therapy with aspirin and clopidogrel will be assessed for (1) clinical risks factors for future bleeding and ischemic complications, and (2) on-treatment platelet reactivity as measured by the VerifyNow P2Y12 assay (Accumetrics, Inc., San Diego, CA, USA). These will be considered by utilization of a clinical algorithm to determine the dual antiplatelet regimen post-PCI (aspirin in combination with 1. clopidogrel, 2. prasugrel 5mg daily, or 3. prasugrel 10mg daily).
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects in any of the participating sites who are on chronic clopidogrel treatment and return for PCI will be considered for this study.
Condition
  • Percutaneous Coronary Intervention
  • Dual Antiplatelet Therapy
  • Aspirin
  • Clopidogrel
Intervention Not Provided
Study Groups/Cohorts
  • SA + 5mg prasugrel
    Prasugrel 5 mg group: Patients with Intermediate or high bleeding risks and PRU ≥ 230 are Prescribed 5mg of prasugrel daily along with aspirin.
  • ASA + 10 mg prasugrel
    Prasugrel 10 mg group: Patients with Low bleeding risk and high ischemia risk and PRU ≥ 230 are prescribed 10 mg of prasugrel daily along with aspirin.
  • ASA + 75 mg clopidogrel daily
    Clopidogrel 75 mg group (control): PRU ≤ 230; high bleeding risk or high ischemic risk; patients with active malignancy, age >75; Wt< 60kg with previous CVA or TA are prescribed 75 mg of clopidogrel daily along with aspirin.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 22, 2015)
318
Original Estimated Enrollment
 (submitted: April 18, 2012)
1000
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • The subject has provided informed written.
  • The subject must be ≥ 18 years of age (or minimum age as required by local regulations) at the time of enrollment.
  • Patient is established on chronic clopidogrel therapy when he/she returns for PCI, and the components of DAPT are determined by the clinical decision algorithm as local standard of care.
  • The subject is willing and able to cooperate with the study procedures and required follow-ups.

Exclusion Criteria:

  • Patients with cardiogenic shock will be excluded.
  • The subject is participating in an investigational device or drug study. Subject must have completed the follow up phase of any previous study at least 30 days prior to enrolment in this study.
  • Pregnant women.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01582217
Other Study ID Numbers GCO 12-0028
FWA # 00005656 and 00005651
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Icahn School of Medicine at Mount Sinai
Study Sponsor Icahn School of Medicine at Mount Sinai
Collaborators
  • Daiichi Sankyo, Inc.
  • Accumetrics, Inc.
Investigators
Principal Investigator: George Dangas, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date December 2015