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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01582217

Acronym

TRIAGE

Enrollment

318

Registered

2012-04-20

Start date

2012-03-31

Completion date

2014-12-31

Last updated

2015-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspirin, Clopidogrel, Dual Antiplatelet Therapy, Percutaneous Coronary Intervention

Keywords

Bleeding, Risk Score, Outcomes, Prasugrel

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
MACE	12 months	Major adverse cardiac events (all-cause death, myocardial infarction and stent thrombosis)

Secondary

Measure	Time frame	Description
Rates of major bleeding	12 months	The rates of major bleeding in patients treated with a thienopyridine based on the clinical algorithm.

Countries

United States

Outcome results