Ignite Creation Date:
2024-05-06 @ 3:22 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02271022
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2014-10-10
Brief Title:
Utilization of Ticagrelor in the Upstream Setting for Non-ST-Segment Elevation Myocardial Infarction UPSTREAM An ED-Based Clinical Registry
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Utilization of Ticagrelor in the Upstream Setting for Non-ST-Segment Elevation Myocardial Infarction UPSTREAM An ED-Based Clinical Registry
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the UPSTREAM Registry is to address the data gap regarding the course of NSTEMI Non-ST-Elevation Myocardial Infarctionbetween 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- ie 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 IIbIIIa 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 ACCAHA 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 interventions 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 andor 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 callchart review
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 IIbIIIa 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 ACCAHA 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 interventions 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 andor 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 callchart review
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None