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Treatment With Adenosine Diphosphate (ADP) Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS)

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01088503
First received: March 15, 2010
Last updated: December 22, 2015
Last verified: December 2015
  Purpose

The TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) study is a prospective, observational longitudinal study to evaluate the real world effectiveness and use of prasugrel and other ADP receptor inhibitor therapies among myocardial infarction (MI) participants treated with percutaneous coronary intervention (PCI) during the index hospitalization. Participant management and treatment decisions are at the discretion of the care team per routine clinical practice. Approximately 17,000 participants will be enrolled at approximately 350 sites in the United States. Follow-up will be conducted through 15 months in approximately 15,650 participants.

TRANSLATE-ACS will complement the results of both randomized controlled clinical trials and current registries in addressing the real world treatment patterns and clinical outcomes for MI participants managed with PCI and initiated on ADP receptor inhibitor therapy. In addition to determining the effectiveness of prasugrel in comparison to other ADP receptor inhibitors, the study will also determine factors associated with initial ADP receptor inhibitor selection and longitudinal patterns of use, evaluate the safety, and describe and compare resource use and medical costs associated with ADP receptor inhibitors. Additionally, this study will generate a continuum of information from the inpatient to outpatient settings to provide a comprehensive picture of participant treatment and outcomes not currently available for novel ADP receptor inhibitors.


Condition Intervention
Acute Coronary Syndrome
Drug: ADP receptor inhibitors

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The TRANSLATE-ACS Study: Treatment With ADP Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Percentage of Participants With Major Adverse Cardiovascular Events (MACE) [ Time Frame: Baseline through 12 months ] [ Designated as safety issue: No ]
    MACE is defined as a composite of all-cause death, myocardial infarction (MI), stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participants = (number of participants with events in 12 months/ number of participants treated) * 100.

  • Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment [ Time Frame: Day 0 (study enrollment) ] [ Designated as safety issue: No ]
    Factors are drug-eluting stent (DES) vs. bare metal stent (BMS) placement, other (no stent) vs. BMS, STEMI, other race, cardiogenic shock occurred within 24 hours, male, European Quality of Life Questionnaire-5 Dimension Health State Score (EQ-5D) - United States (US) Index =1 vs. <1, married, diabetes, and other vs. BMS placement. The EQ-5D US index is a participant-rated, health-related, quality-of-life instrument based on US population. Scores range from -0.11 to 1.0 with 1.0 = perfect health.

  • Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Pre-Procedure Hemoglobin [ Time Frame: Day 0 (study enrollment) ] [ Designated as safety issue: No ]
  • Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Duke Coronary Artery Disease (CAD) Index [ Time Frame: Day 0 (study enrollment) ] [ Designated as safety issue: No ]
    The Duke CAD Index is a validated composite measure of angiographic burden, which assigns prognostic weights 1 through 100. Higher scores indicate greater angiographic burden and are associated with poorer prognosis.


Secondary Outcome Measures:
  • Percentage of Participants With Cumulative Severe or Moderate Bleeding Events [ Time Frame: Baseline, 1, 6, 12 and 15 months ] [ Designated as safety issue: Yes ]
    Bleeding events were collected utilizing the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) definition of bleeding. Non-coronary artery bypass grafting (CABG)-related GUSTO severe or life-threatening bleeding is any intracranial hemorrhage (ICH) OR any bleeding event resulting in substantial hemodynamic compromise requiring treatment. Non-CABG-related GUSTO moderate bleeding is any bleeding event resulting in the need for transfusion that is not considered a GUSTO severe or life-threatening bleed. Additional bleeding events are fatal bleeding or ICH, or any non -fatal surgical-related bleeding events leading to ≥4 units of red cell transfusion. Observed (unadjusted) percentages of participants with bleeding events, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participants = (number of participants with events / number of participants treated) * 100.

  • Percentage of Participants With MACE and Who Had No Prior History of Transient Ischemic Attack (TIA)/Stroke, Weigh ≥60 Kilograms (kg), and Are Age <75 Years [ Time Frame: Baseline through 12 months ] [ Designated as safety issue: No ]
    MACE is defined as a composite of all-cause death, MI, stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participant = (number of participants with events / number of participants treated) * 100.

  • Percentage of Participants With MACE Over 1, 6 and 15 Months [ Time Frame: Baseline through 1, 6 and 15 months ] [ Designated as safety issue: No ]
    MACE is defined as a composite of all-cause death, MI, stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE are presented. Kaplan-Meier analysis was used to estimate the percentage of participants with a MACE event.

  • Percentage of Participants With Definite or Probable Stent Thrombosis (ST) Events [ Time Frame: Baseline through 15 months ] [ Designated as safety issue: No ]
    Academic Research Consortium (ARC) criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least 1 of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with ST events are presented. Kaplan-Meier analysis was used to estimate the percentage of participants with a definite or probable ST event.

  • Resource Use Patterns, Cumulative Total Medical Costs, and Cost Effectiveness [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Enrollment: 12227
Study Start Date: March 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ADP receptor inhibitor treatment
Participants admitted for non ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) and treated with an ADP receptor inhibitor during the index hospitalization.
Drug: ADP receptor inhibitors
Dosage regimen as determined by the treating physician.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants admitted or already in hospital with acute myocardial infarction (MI) who are treated with percutaneous coronary intervention (PCI) and an ADP receptor inhibitor.
Criteria

Inclusion Criteria:

  • greater than or equal to 18 years of age
  • diagnosed with NSTEMI or STEMI treated with a PCI during the index hospitalization
  • initiated (or continued) on ADP receptor inhibitor therapy before discharge
  • fully informed and are able to provide written consent for longitudinal follow-up and data collection

Exclusion Criteria:

  • simultaneously participating in a research study that directs choice of either an investigational or approved ADP receptor inhibitor within the first 12 months after MI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088503

  Show 186 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Daiichi Sankyo Inc.
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours EST) Eli Lilly and Company
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01088503     History of Changes
Other Study ID Numbers: 12549  H7T-US-B007 
Study First Received: March 15, 2010
Results First Received: January 29, 2015
Last Updated: December 22, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 26, 2016