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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:
ClinicalTrials.gov Identifier:
NCT01088503
First Posted: March 17, 2010
Last Update Posted: January 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company
  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 ]
    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) ]
    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) ]
  • Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Duke Coronary Artery Disease (CAD) Index [ Time Frame: Day 0 (study enrollment) ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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):
Hess CN, Kaltenbach LA, Doll JA, Cohen DJ, Peterson ED, Wang TY. Race and Sex Differences in Post-Myocardial Infarction Angina Frequency and Risk of 1-Year Unplanned Rehospitalization. Circulation. 2017 Feb 7;135(6):532-543. doi: 10.1161/CIRCULATIONAHA.116.024406.
Jackson LR 2nd, Peterson ED, McCoy LA, Ju C, Zettler M, Baker BA, Messenger JC, Faries DE, Effron MB, Cohen DJ, Wang TY. Impact of Proton Pump Inhibitor Use on the Comparative Effectiveness and Safety of Prasugrel Versus Clopidogrel: Insights From the Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS) Study. J Am Heart Assoc. 2016 Oct 21;5(10). pii: e003824.
Fosbøl EL, Ju C, Anstrom KJ, Zettler ME, Messenger JC, Waksman R, Effron MB, Baker BA, Cohen DJ, Peterson ED, Wang TY. Early Cessation of Adenosine Diphosphate Receptor Inhibitors Among Acute Myocardial Infarction Patients Treated With Percutaneous Coronary Intervention: Insights From the TRANSLATE-ACS Study (Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome). Circ Cardiovasc Interv. 2016 Nov;9(11). pii: e003602.
Krishnamoorthy A, Peterson ED, Knight JD, Anstrom KJ, Effron MB, Zettler ME, Davidson-Ray L, Baker BA, McCollam PL, Mark DB, Wang TY. How Reliable are Patient-Reported Rehospitalizations? Implications for the Design of Future Practical Clinical Studies. J Am Heart Assoc. 2016 Jan 25;5(1). pii: e002695. doi: 10.1161/JAHA.115.002695.
Hess CN, Wang TY, McCoy LA, Messenger JC, Effron MB, Zettler ME, Henry TD, Peterson ED, Fonarow GC. Unplanned Inpatient and Observation Rehospitalizations After Acute Myocardial Infarction: Insights From the Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS) Study. Circulation. 2016 Feb 2;133(5):493-501. doi: 10.1161/CIRCULATIONAHA.115.017001. Epub 2015 Dec 17.
Wang TY, Henry TD, McCoy LA, Berger PB, Cohen DJ, Effron MB, Zettler M, Baker BA, Messenger JC, Peterson ED. Contemporary use of platelet function and pharmacogenomic testing among patients with acute myocardial infarction undergoing percutaneous coronary intervention in the United States. Am Heart J. 2015 Oct;170(4):706-14. doi: 10.1016/j.ahj.2015.06.021. Epub 2015 Jul 2.
Mathews R, Wang TY, Honeycutt E, Henry TD, Zettler M, Chang M, Fonarow GC, Peterson ED; TRANSLATE-ACS Study Investigators. Persistence with secondary prevention medications after acute myocardial infarction: Insights from the TRANSLATE-ACS study. Am Heart J. 2015 Jul;170(1):62-9. doi: 10.1016/j.ahj.2015.03.019. Epub 2015 Apr 2.
Mathews R, Peterson ED, Honeycutt E, Chin CT, Effron MB, Zettler M, Fonarow GC, Henry TD, Wang TY. Early Medication Nonadherence After Acute Myocardial Infarction: Insights into Actionable Opportunities From the TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) Study. Circ Cardiovasc Qual Outcomes. 2015 Jul;8(4):347-56. doi: 10.1161/CIRCOUTCOMES.114.001223. Epub 2015 Jun 2.
Wang TY, Henry TD, Effron MB, Honeycutt E, Hess CN, Zettler ME, Cohen DJ, Baker BA, Berger PB, Anstrom KJ, Angiolillo DJ, Peterson ED; TRANSLATE-POPS Investigators. Cluster-randomized clinical trial examining the impact of platelet function testing on practice: the treatment with adenosine diphosphate receptor inhibitors: longitudinal assessment of treatment patterns and events after acute coronary syndrome prospective open label antiplatelet therapy study. Circ Cardiovasc Interv. 2015 Jun;8(6):e001712. doi: 10.1161/CIRCINTERVENTIONS.114.001712.
Xian Y, Wang TY, McCoy LA, Effron MB, Henry TD, Bach RG, Zettler ME, Baker BA, Fonarow GC, Peterson ED. Association of Discharge Aspirin Dose With Outcomes After Acute Myocardial Infarction: Insights From the Treatment with ADP Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) Study. Circulation. 2015 Jul 21;132(3):174-81. doi: 10.1161/CIRCULATIONAHA.114.014992. Epub 2015 May 20.
Bagai A, Peterson ED, Honeycutt E, Effron MB, Cohen DJ, Goodman SG, Anstrom KJ, Gupta A, Messenger JC, Wang TY. In-hospital switching between adenosine diphosphate receptor inhibitors in patients with acute myocardial infarction treated with percutaneous coronary intervention: Insights into contemporary practice from the TRANSLATE-ACS study. Eur Heart J Acute Cardiovasc Care. 2015 Dec;4(6):499-508. doi: 10.1177/2048872614564082. Epub 2014 Dec 16.
Hess CN, McCoy LA, Duggirala HJ, Tavris DR, O'Callaghan K, Douglas PS, Peterson ED, Wang TY. Sex-based differences in outcomes after percutaneous coronary intervention for acute myocardial infarction: a report from TRANSLATE-ACS. J Am Heart Assoc. 2014 Feb 7;3(1):e000523. doi: 10.1161/JAHA.113.000523.
Wang TY, McCoy L, Henry TD, Effron MB, Messenger JC, Cohen DJ, Mark DB, Stone GW, Zettler M, Singh M, Fonarow GC, Peterson ED; TRANSLATE-ACS Study Investigators. Early post-discharge bleeding and antiplatelet therapy discontinuation among acute myocardial infarction patients treated with percutaneous coronary intervention. J Am Coll Cardiol. 2014 Apr 29;63(16):1700-2. doi: 10.1016/j.jacc.2013.12.012. Epub 2014 Jan 30.
Chin CT, Wang TY, Anstrom KJ, Zhu B, Maa JF, Messenger JC, Ryan KA, Davidson-Ray L, Zettler M, Effron MB, Mark DB, Peterson ED. Treatment with adenosine diphosphate receptor inhibitors-longitudinal assessment of treatment patterns and events after acute coronary syndrome (TRANSLATE-ACS) study design: expanding the paradigm of longitudinal observational research. Am Heart J. 2011 Nov;162(5):844-51. doi: 10.1016/j.ahj.2011.08.021.

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01088503     History of Changes
Other Study ID Numbers: 12549
H7T-US-B007 ( Other Identifier: Eli Lilly and Company )
First Submitted: March 15, 2010
First Posted: March 17, 2010
Results First Submitted: January 29, 2015
Results First Posted: January 29, 2016
Last Update Posted: January 29, 2016
Last Verified: December 2015

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


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