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: February 18, 2014
Last verified: February 2014
  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) patients treated with percutaneous coronary intervention (PCI) during the index hospitalization. Patient management and treatment decisions are at the discretion of the care team per routine clinical practice. Approximately 17,000 patients will be enrolled at approximately 350 sites in the United States. Follow-up will be conducted through 15 months in approximately 15,650 patients.

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 patients 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 patient 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Major adverse cardiovascular events (MACE) [ Time Frame: 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

  • Factors associated with initial ADP receptor inhibitor selection at enrollment and longitudinal patterns of use [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bleeding outcomes [ Time Frame: Index hospitalization, 1, 6, 12, 15 months ] [ Designated as safety issue: Yes ]
  • MACE and bleeding outcomes in patients who have no prior history of transient ischemic attack (TIA)/stroke, weigh ≥60 kg, and are age <75 years old [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • MACE [ Time Frame: Index hospitalization, 1, 6, 15 months ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Resource use patterns, cumulative total medical costs, and cost effectiveness [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 17350
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
Patients 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients 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

No publications provided by Eli Lilly and Company

Additional 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
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014