Utilization of Ticagrelor in the Upstream Setting for Non-ST-Segment Elevation Myocardial Infarction (UPSTREAM): An ED-Based Clinical Registry
Condition: Acute Coronary Syndromes
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Infarction
Study type: Observational [Patient Registry]

Summary: 
      The primary objective of the UPSTREAM Registry is to address the data gap regarding the
      course of NSTEMI (Non-ST-Elevation Myocardial Infarction)between ED (Emergency Department)
      arrival and diagnostic angiography in detail, by characterizing and following the ED and
      peri-ED use of advanced OAP (Oral Anti-Platelet) agents. In addition to exploring ED
      treatment patterns and success of both ischemic and bleeding risk stratification prior to
      definition of the coronary anatomy, data generated via the UPSTREAM registry will allow
      plausible attribution of ischemic and bleeding outcomes to pre-catheterization antiplatelet
      therapy in the management of NSTEMI. This registry further seeks to demonstrate that
      contemporary use of upstream ticagrelor is associated with an economically-sound utilization
      of hospital resources, and smooth transition of care into the outpatient, secondary
      prevention setting for the first 30 days after hospitalization. Finally, it will allow
      characterization of patient selection factors and processes for ticagrelor vs alternative OAP
      agents, carrying out that descriptive comparison through discharge. Patients transferred in
      to an UPSTREAM hospital are eligible for inclusion, but the timing for OAP agent
      administration and diagnostic catheterization begin with ED care at the first hospital.
    

Detailed description: 
      This is a Phase IV, post-approval, multicenter, prospective, noninterventional study of
      consecutive patients with a working diagnosis of NSTEMI (Non-ST-Elevation Myocardial
      Infarction) and treatment with an OAP (Oral Anti-Platelet) agent (ticagrelor, clopidogrel, or
      prasugrel) either in the ED (Emergency Department), or in any case within the timeframe that
      emergency physicians consider to be "upstream"- i.e., within the first 72 hours after ED
      arrival and at least 4 hours before diagnostic angiography. This registry is designed to
      address the data gap regarding the course of NSTEMI between ED arrival and diagnostic
      angiography in detail, by characterizing and following the ED and peri-ED use of advanced OAP
      agents.

      Demographic, ischemic vs bleeding risk stratification [calculated retrospectively by GRACE
      (Global Registry of Acute Coronary Events), TIMI (Thrombolysis in Myocardial Infarction), and
      PURSUIT (Platelet glycoprotein IIb/IIIa in Unstable angina: Receptor Suppression Using
      Integrilin) scores, and CRUSADE (Can Rapid risk stratification of Unstable angina patients
      Suppress ADverse outcomes with Early implementation of the ACC/AHA guidelines) Bleeding
      Score, respectively], and OAP agent data (including, when discernible, rationale for agent
      selection) will be collected for all UPSTREAM patients, regardless of OAP therapy, through
      discharge. Risk factors, angiography results, intervention/s (if any), post-catheterization
      care, discharge regimens, and in-hospital outcomes will be recorded.

      Patients who are treated upstream, in-hospital, and are discharged home on ticagrelor, will
      be further followed up, by telephone and/or chart review (if necessary elements are included
      in chart accessible to investigator), at 30 (+10) days post-discharge, during which
      evaluation data elements to be collected include patient-reported compliance with visits and
      medications, patient-reported healthcare resource utilization, and any pertinent events or
      complications.

      Patients who are treated upstream, in-hospital, or discharged home on a different OAP therapy
      (clopidogrel or prasugrel) will not be followed beyond the data collection completed at
      hospital discharge. It is expected that a relatively small number of patients will change
      therapy from ticagrelor to another OAP agent after discharge and prior to 30 days
      post-discharge, though such changes will be queried in the 30-day call/chart review.
    

Intervention name(s): Non-Interventional Study
Intervention type(s): Other
Intervention description(s): Non-Interventional Study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients (≥18 years of age) with a working diagnosis of NSTEMI and treatment with an OAP
        agent (ticagrelor, clopidogrel, or prasugrel) either in the ED, or in any case within the
        timeframe that emergency physicians consider to be "upstream"-within the first 72 hours of
        care and at least 4 hours before diagnostic angiography. In addition, only those patients
        who undergo a diagnostic coronary angiography within 72 hours of ED arrival will be
        eligible for UPSTREAM.
      
Keywords: ACS, Acute Coronary Syndromes; NSTEMI; MI, Myocardial Infarction