Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborators:
Daiichi Sankyo Inc.
Accumetrics, Inc.
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT01582217
First received: April 18, 2012
Last updated: December 22, 2015
Last verified: December 2015
  Purpose
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.

Condition
Percutaneous Coronary Intervention
Dual Antiplatelet Therapy
Aspirin
Clopidogrel

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: TRIAGE: Patients Undergoing Percutaneous Coronary Interventions to Improve Clinical Outcomes Through Optimal Platelet Inhibition

Further study details as provided by Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • MACE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Major adverse cardiac events (all-cause death, myocardial infarction and stent thrombosis)


Secondary Outcome Measures:
  • Rates of major bleeding [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The rates of major bleeding in patients treated with a thienopyridine based on the clinical algorithm.


Enrollment: 318
Study Start Date: March 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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.

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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
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.
  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: NCT01582217

Locations
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Daiichi Sankyo Inc.
Accumetrics, Inc.
Investigators
Principal Investigator: George Dangas, MD Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01582217     History of Changes
Other Study ID Numbers: GCO 12-0028  FWA # 00005656 and 00005651 
Study First Received: April 18, 2012
Last Updated: December 22, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Australia: Department of Health and Ageing Therapeutic Goods Administration
Brazil: Ministry of Health

Keywords provided by Icahn School of Medicine at Mount Sinai:
Bleeding
Risk Score
Outcomes
Prasugrel

Additional relevant MeSH terms:
Clopidogrel
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016