Acute Coronary SyndromesNCT02271022
Utilization of Ticagrelor in the Upstream Setting for Non-ST-Segment Elevation Myocardial Infarction (UPSTREAM): An ED-Based Clinical Registry
An observational study of Acute Coronary Syndromes, run by AstraZeneca at 55 sites in United States.
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)… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- Non-Interventional Study
- How many people
- 2,000 participants
- Where
- 55 sitesUnited States
- Study dates
- 17 Feb 2015to 31 Oct 2019
- How long will I take part?
- 40 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
55 sites in 1 country.
55 sites in 1 country
United States55 sites
Research Site
Atlanta, Georgia, 30322
Research Site
Baltimore, Maryland, 20814
Research Site
Baltimore, Maryland, 21215
Research Site
Baltimore, Maryland, 21287
Research Site
Birmingham, Alabama, 35233
Research Site
Bloomfield, Michigan, 48323
Research Site
Boston, Massachusetts, 02115
Research Site
Bridgeport, Connecticut, 06610
Research Site
Brooklyn, New York, 11215
Research Site
Camden, New Jersey, 08103
Research Site
Charlottesville, Virginia, 22903
Research Site
Cleveland, Ohio, 44195
Research Site
Dallas, Texas, 75246
Research Site
Duluth, Minnesota, 55805
Research Site
Durham, North Carolina, 27710
Research Site
Flemington, New Jersey, 08822
Research Site
Gainesville, Florida, 32603
Research Site
Galveston, Texas, 77550
Research Site
Grand Blanc, Michigan, 48439
Research Site
Hartford, Connecticut, 06102
Research Site
Hialeah, Florida, 33016
Research Site
Kansas City, Missouri, 64106
Research Site
Kansas City, Missouri, 64111
Research Site
Kansas City, Missouri, 64116
Research Site
Little Rock, Arkansas, 72211
Research Site
Macon, Georgia, 31217
Research Site
Manitowoc, Wisconsin, 54221
Research Site
McKinney, Texas, 75069
Research Site
Memphis, Tennessee, 37920
Research Site
Memphis, Tennessee, 38120
Research Site
Miami, Florida, 33136
Research Site
Milwaukee, Wisconsin, 53226
Research Site
Mobile, Alabama, 36688
Research Site
Nashville, Tennessee, 37203
Research Site
New Braunfels, Texas, 78132
Research Site
New York, New York, 10029
Research Site
New York, New York, 11235
Research Site
Newark, New Jersey, 07102
Research Site
Oklahoma City, Oklahoma, 73135
Research Site
Peoria, Illinois, 61614
Research Site
Philadelphia, Pennsylvania, 19107
Research Site
Philadelphia, Pennsylvania, 19141
Research Site
Piscataway, New Jersey, 08854
Research Site
Richmond, Indiana, 47374
Research Site
Roseburg, Oregon, 97471
Research Site
Royal Oak, Michigan, 48073
Research Site
Sacramento, California, 95812
Research Site
Saint Paul, Minnesota, 55101
Research Site
Springfield, Missouri, 65807
Research Site
Tacoma, Washington, 98405
Research Site
Tampa, Florida, 33606
Research Site
Teaneck, New Jersey, 07666
Research Site
Washington D.C., District of Columbia, 20036
Research Site
Worcester, Massachusetts, 06105
Research Site
York and Ephrata, Pennsylvania, 17403
About this study
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.
Read the 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.
- Conditions
- Acute Coronary Syndromes
- Being tested
- Non-Interventional Study
- Keywords
- ACS, Acute Coronary Syndromes, NSTEMI, MI, Myocardial Infarction
- Medical subject headings
- Acute Coronary Syndrome, Non-ST Elevated Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-Interventional Study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 30 days
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.
Measured: 30 days
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study start17 Feb 2015
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 40 Days
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles V. Pollack, MA, MD, FACEP, FAAEM, FAHA, Principal investigator, Hospital Quality Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271022
- Sponsor's protocol ID
- NIS-BRIL-UPSTREAM
- Status last verified
- Oct 2020
- First submitted
- 10 Oct 2014
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Ticagrelor in the Upstream Setting for Non-ST-Segment Elevation Myocardial Infarction (UPSTREAM): An ED-Based Clinical Registry
- ClinicalTrials.gov ID
- NCT02271022
- Acronym / sponsor ID
- NIS-BRIL-UPSTREAM
- Conditions
- Acute Coronary Syndromes
- Keywords
- ACS, Acute Coronary Syndromes, NSTEMI, MI, Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2015 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 40 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Non-Interventional StudyPatients (≥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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-Interventional Study | Other | Cohort 1 |
Primary outcome
Composite and individual components of cardiovascular death, MI, and stroke
Time frame: 30 days
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.
Bleeding rates within 30 days
Time frame: 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.
3 secondary outcomes
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
Time frame: 30 days
Time between administration of first upstream OAP agent and catheterization
Time frame: 30 days
Healthcare Resource Utilization
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- study report synopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles V. Pollack, MA, MD, FACEP, FAAEM, FAHA principal investigator
Hospital Quality Foundation
55 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndromes, run by AstraZeneca at 55 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite and individual components of cardiovascular death, MI, and stroke (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.