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

NCT02271022 | Completed

• 1 other identifier: NIS-BRIL-UPSTREAM
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 55

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.

Conditions

Acute Coronary Syndromes

Keywords

ACS, Acute Coronary Syndromes; NSTEMI; MI, Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

• Composite and individual components of cardiovascular death, MI, and stroke

  In patients who are treated upstream, in-hospital, and who are on ticagrelor at the end of 30-days post-discharge, composite and individual components of cardiovascular death, MI (Myocardial Infarction), and stroke, and bleeding rates will be assessed within 30 days.

  30 days

• Bleeding rates within 30 days

  In patients who are treated upstream, in-hospital, and who are on ticagrelor at the end of 30-days post-discharge, bleeding occurring in-hospital will be classified according to the TIMI, GUSTO (Global Use of Strategies to Open Occluded Arteries), PLATO (PLATelet inhibition and patient Outcomes), and BARC (Bleeding Academic Research Consortium) scales; bleeding reported by the patient at 30-day follow-up will also be assessed.

  30 days

Secondary Outcomes (3)

• 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

  30 days

• Time between administration of first upstream OAP agent and catheterization

  30 days

• Healthcare Resource Utilization

  30 days

Study Arms (1)

Cohort 1

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.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-Interventional Study

Cohort 1

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Life expectancy less than 90 days in opinion of treating clinician;
• Not undergoing diagnostic angiography within 72 hours of ED arrival;
• Refusal of consent; or
• Unlikely to comply with follow-up by telephone.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (55)

Research Site

Birmingham, Alabama, 35233, United States

Location

Research Site

Mobile, Alabama, 36688, United States

Location

Research Site

Little Rock, Arkansas, 72211, United States

Location

Research Site

Sacramento, California, 95812, United States

Location

Research Site

Bridgeport, Connecticut, 06610, United States

Location

Research Site

Hartford, Connecticut, 06102, United States

Location

Research Site

Washington D.C., District of Columbia, 20036, United States

Location

Research Site

Gainesville, Florida, 32603, United States

Location

Research Site

Hialeah, Florida, 33016, United States

Location

Research Site

Miami, Florida, 33136, United States

Location

Research Site

Tampa, Florida, 33606, United States

Location

Research Site

Atlanta, Georgia, 30322, United States

Location

Research Site

Macon, Georgia, 31217, United States

Location

Research Site

Peoria, Illinois, 61614, United States

Location

Research Site

Richmond, Indiana, 47374, United States

Location

Research Site

Baltimore, Maryland, 20814, United States

Location

Research Site

Baltimore, Maryland, 21215, United States

Location

Research Site

Baltimore, Maryland, 21287, United States

Location

Research Site

Boston, Massachusetts, 02115, United States

Location

Research Site

Worcester, Massachusetts, 06105, United States

Location

Research Site

Bloomfield, Michigan, 48323, United States

Location

Research Site

Grand Blanc, Michigan, 48439, United States

Location

Research Site

Royal Oak, Michigan, 48073, United States

Location

Research Site

Duluth, Minnesota, 55805, United States

Location

Research Site

Saint Paul, Minnesota, 55101, United States

Location

Research Site

Kansas City, Missouri, 64106, United States

Location

Research Site

Kansas City, Missouri, 64111, United States

Location

Research Site

Kansas City, Missouri, 64116, United States

Location

Research Site

Springfield, Missouri, 65807, United States

Location

Research Site

Camden, New Jersey, 08103, United States

Location

Research Site

Flemington, New Jersey, 08822, United States

Location

Research Site

Newark, New Jersey, 07102, United States

Location

Research Site

Piscataway, New Jersey, 08854, United States

Location

Research Site

Teaneck, New Jersey, 07666, United States

Location

Research Site

Brooklyn, New York, 11215, United States

Location

Research Site

New York, New York, 10029, United States

Location

Research Site

New York, New York, 11235, United States

Location

Research Site

Durham, North Carolina, 27710, United States

Location

Research Site

Cleveland, Ohio, 44195, United States

Location

Research Site

Oklahoma City, Oklahoma, 73135, United States

Location

Research Site

Roseburg, Oregon, 97471, United States

Location

Research Site

Philadelphia, Pennsylvania, 19107, United States

Location

Research Site

Philadelphia, Pennsylvania, 19141, United States

Location

Research Site

York and Ephrata, Pennsylvania, 17403, United States

Location

Research Site

Memphis, Tennessee, 37920, United States

Location

Research Site

Memphis, Tennessee, 38120, United States

Location

Research Site

Nashville, Tennessee, 37203, United States

Location

Research Site

Dallas, Texas, 75246, United States

Location

Research Site

Galveston, Texas, 77550, United States

Location

Research Site

McKinney, Texas, 75069, United States

Location

Research Site

New Braunfels, Texas, 78132, United States

Location

Research Site

Charlottesville, Virginia, 22903, United States

Location

Research Site

Tacoma, Washington, 98405, United States

Location

Research Site

Manitowoc, Wisconsin, 54221, United States

Location

Research Site

Milwaukee, Wisconsin, 53226, United States

Location

Related Links

• study report synopsis

MeSH Terms

Conditions

Acute Coronary Syndrome; Non-ST Elevated Myocardial Infarction; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Charles V. Pollack, MA, MD, FACEP, FAAEM, FAHA

  Hospital Quality Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 40 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: October 22, 2014
• Study Start: February 17, 2015
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: November 3, 2020

Record last verified: 2020-10

Locations

US (55)