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TRIAGE: Patients Undergoing Percutaneous Coronary Interventions to Improve Clinical Outcomes Through Optimal Platelet Inhibition


N/A
18 Years
N/A
Open (Enrolling)
Both
Percutaneous Coronary Intervention, Dual Antiplatelet Therapy, Aspirin, Clopidogrel

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Trial Information

TRIAGE: Patients Undergoing Percutaneous Coronary Interventions to Improve Clinical Outcomes Through Optimal Platelet Inhibition


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).


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

MACE

Outcome Description:

Major adverse cardiac events (all-cause death, myocardial infarction and stent thrombosis)

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

George Dangas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

GCO 12-0028

NCT ID:

NCT01582217

Start Date:

March 2012

Completion Date:

February 2014

Related Keywords:

  • Percutaneous Coronary Intervention
  • Dual Antiplatelet Therapy
  • Aspirin
  • Clopidogrel
  • Bleeding
  • Risk Score
  • Outcomes
  • Prasugrel

Name

Location
Mount Sinai Medical Center New York, New York  10029