Utilization of Ticagrelor in the Upstream Setting for Non-ST-Segment Elevation Myocardial Infarction (UPSTREAM): An ED-Based Clinical Registry



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 99
Updated:3/27/2019
Start Date:February 17, 2015
End Date:March 31, 2020
Contact:AstraZeneca Clinical Study Information Center
Email:information.center@astrazeneca.com
Phone:1-877-240-9479

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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.

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.

Inclusion Criteria:

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"- i.e., 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.

Exclusion Criteria:

1. Life expectancy less than 90 days in opinion of treating clinician;

2. Not undergoing diagnostic angiography within 72 hours of ED arrival;

3. Refusal of consent; or

4. Unlikely to comply with follow-up by telephone.
We found this trial at
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