Clinical trial NCT02271022: Utilization of Ticagrelor in the Upstream Setting for Non-ST-Segment Elevation Myocardial Infarction (UPSTREAM): An ED-Based Clinical Registry
Official title: Utilization of Ticagrelor in the Upstream Setting for Non-ST-Segment Elevation Myocardial Infarction (UPSTREAM): An ED-Based Clinical Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndromes
Keywords: ACS, Acute Coronary Syndromes
NSTEMI
MI, Myocardial Infarction
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-10-22
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite and individual components of cardiovascular death, MI, and stroke
timeFrame: 30 days
measure: Bleeding rates within 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Choice of alternative OAP agents in either the upstream setting or after switching from upstream ticagrelor to downstream or discharge clopidogrel or prasugrel will be explored and analyzed
timeFrame: 30 days
measure: Time between administration of first upstream OAP agent and catheterization
timeFrame: 30 days
measure: Healthcare Resource Utilization
timeFrame: 30 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Sacramento
country: United States
facility: Research Site
state: California
city: Bridgeport
country: United States
facility: Research Site
state: Connecticut
city: Hartford
country: United States
facility: Research Site
state: Connecticut
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Macon
country: United States
facility: Research Site
state: Georgia
city: Peoria
country: United States
facility: Research Site
state: Illinois
city: Richmond
country: United States
facility: Research Site
state: Indiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Worcester
country: United States
facility: Research Site
state: Massachusetts
city: Bloomfield
country: United States
facility: Research Site
state: Michigan
city: Grand Blanc
country: United States
facility: Research Site
state: Michigan
city: Royal Oak
country: United States
facility: Research Site
state: Michigan
city: Duluth
country: United States
facility: Research Site
state: Minnesota
city: Saint Paul
country: United States
facility: Research Site
state: Minnesota
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: Springfield
country: United States
facility: Research Site
state: Missouri
city: Camden
country: United States
facility: Research Site
state: New Jersey
city: Flemington
country: United States
facility: Research Site
state: New Jersey
city: Newark
country: United States
facility: Research Site
state: New Jersey
city: Piscataway
country: United States
facility: Research Site
state: New Jersey
city: Teaneck
country: United States
facility: Research Site
state: New Jersey
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Roseburg
country: United States
facility: Research Site
state: Oregon
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: York And Ephrata
country: United States
facility: Research Site
state: Pennsylvania
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Galveston
country: United States
facility: Research Site
state: Texas
city: McKinney
country: United States
facility: Research Site
state: Texas
city: New Braunfels
country: United States
facility: Research Site
state: Texas
city: Charlottesville
country: United States
facility: Research Site
state: Virginia
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Manitowoc
country: United States
facility: Research Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: Hospital Quality Foundation
name: Charles V. Pollack, MA, MD, FACEP, FAAEM, FAHA
role: PRINCIPAL_INVESTIGATOR
References: