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

Percutaneous Coronary Intervention Clinical Trial

— TRIAGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582217
• Other study ID #: GCO 12-0028
• Secondary ID: FWA # 00005656 a
• Status: Completed
• Phase: N/A
• First received: April 18, 2012
• Last updated: December 22, 2015
• Start date: March 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBrazil: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aspirin
• Clopidogrel
• Dual Antiplatelet Therapy
• Percutaneous Coronary Intervention

Locations

Country	Name	City	State
United States	Mount Sinai Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Accumetrics, Inc., Daiichi Sankyo Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE	Major adverse cardiac events (all-cause death, myocardial infarction and stent thrombosis)	12 months	Yes
Secondary	Rates of major bleeding	The rates of major bleeding in patients treated with a thienopyridine based on the clinical algorithm.	12 months	Yes