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

Acute Coronary Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271022
• Other study ID #: NIS-BRIL-UPSTREAM
• Status: Completed
• Start date: February 17, 2015
• Est. completion date: October 31, 2019

Study information

• Verified date: October 2020
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Infarction
• Myocardial Infarction

Intervention

Other:
• Non-Interventional Study
Non-Interventional Study

Locations

Country	Name	City	State
United States	Research Site	Atlanta	Georgia
United States	Research Site	Baltimore	Maryland
United States	Research Site	Baltimore	Maryland
United States	Research Site	Baltimore	Maryland
United States	Research Site	Birmingham	Alabama
United States	Research Site	Bloomfield	Michigan
United States	Research Site	Boston	Massachusetts
United States	Research Site	Bridgeport	Connecticut
United States	Research Site	Brooklyn	New York
United States	Research Site	Camden	New Jersey
United States	Research Site	Charlottesville	Virginia
United States	Research Site	Cleveland	Ohio
United States	Research Site	Dallas	Texas
United States	Research Site	Duluth	Minnesota
United States	Research Site	Durham	North Carolina
United States	Research Site	Flemington	New Jersey
United States	Research Site	Gainesville	Florida
United States	Research Site	Galveston	Texas
United States	Research Site	Grand Blanc	Michigan
United States	Research Site	Hartford	Connecticut
United States	Research Site	Hialeah	Florida
United States	Research Site	Kansas City	Missouri
United States	Research Site	Kansas City	Missouri
United States	Research Site	Kansas City	Missouri
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Macon	Georgia
United States	Research Site	Manitowoc	Wisconsin
United States	Research Site	McKinney	Texas
United States	Research Site	Memphis	Tennessee
United States	Research Site	Memphis	Tennessee
United States	Research Site	Miami	Florida
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Mobile	Alabama
United States	Research Site	Nashville	Tennessee
United States	Research Site	New Braunfels	Texas
United States	Research Site	New York	New York
United States	Research Site	New York	New York
United States	Research Site	Newark	New Jersey
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Peoria	Illinois
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Piscataway	New Jersey
United States	Research Site	Richmond	Indiana
United States	Research Site	Roseburg	Oregon
United States	Research Site	Royal Oak	Michigan
United States	Research Site	Sacramento	California
United States	Research Site	Saint Paul	Minnesota
United States	Research Site	Springfield	Missouri
United States	Research Site	Tacoma	Washington
United States	Research Site	Tampa	Florida
United States	Research Site	Teaneck	New Jersey
United States	Research Site	Washington	District of Columbia
United States	Research Site	Worcester	Massachusetts
United States	Research Site	York And Ephrata	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	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
Secondary	Time between administration of first upstream OAP agent and catheterization	Time between administration of first upstream OAP agent and catheterization will be analyzed as a continuous variable to assess more broadly the impact of OAP treatment prior to diagnostic angiography in NSTEMI.	30 days
Secondary	Healthcare Resource Utilization	In patients who are treated upstream, in-hospital, and who are on ticagrelor at the end of 30-days post-discharge, healthcare resource utilization data will be captured throughout the 30 day continuum.	30 days

External Links

•   study report synopsis