AzTrials
AzTrials

Acute Coronary SyndromeTRANSLATE-ACSNCT01088503

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

An observational study of Acute Coronary Syndrome, run by Eli Lilly and Company at 186 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
ADP receptor inhibitors
How many people
12,227 participants
Where
186 sitesin 2 countries
Study dates
Mar 2010to Jan 2014
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

186 sites in 2 countries.

186 sites in 2 countries

United States185 sites

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Abington, Pennsylvania, 19001

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    Albuquerque, New Mexico, 87131

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    Alexandria, Louisiana, 71301

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    Allentown, Pennsylvania, 18104

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    Anchorage, Alaska, 99508

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    Anderson, South Carolina, 29621

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    Ann Arbor, Michigan, 48109

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    Annapolis, Maryland, 21401

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    Atlantis, Florida, 33462

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    Aurora, Colorado, 80045

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    Baltimore, Maryland, 21215

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    Bay City, Michigan, 48708

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    Bellevue, Washington, 98004

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    Bend, Oregon, 97701

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    Berkeley, California, 94705

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    Birmingham, Alabama, 35233

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    Bozeman, Montana, 59715

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    Brandon, Florida, 33511

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    Bridgeport, Connecticut, 06610

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    Bridgewater, New Jersey, 08807

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    Brooklyn, New York, 11215

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    Bryn Mawr, Pennsylvania, 19010

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    Camp Hill, Pennsylvania, 17011

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    Canton, Ohio, 44710

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    Carbondale, Illinois, 62901

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    Chapel Hill, North Carolina, 27599

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    Charleston, South Carolina, 29485

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    Charlottesville, Virginia, 22908

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    Cherry Hill, New Jersey, 08034

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    Chesapeake, Virginia, 23320

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    Chicago, Illinois, 60625

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    Cincinnati, Ohio, 45267

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    Columbia, Missouri, 65212

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    Columbia, South Carolina, 29203

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    Columbus, Georgia, 31904

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    Coon Rapids, Minnesota, 55433

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    Crestview Hills, Kentucky, 41017

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    Cumberland, Maryland, 21502

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    Dallas, Texas, 75216

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    Danbury, Connecticut, 06810

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    Danville, Pennsylvania, 17822

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    Danville, Virginia, 24541

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    Darby, Pennsylvania, 19023

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    Davenport, Iowa, 52803

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    Dearborn, Michigan, 48124

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    Decatur, Texas, 76234

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    Detroit, Michigan, 48202

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    Duluth, Minnesota, 55805

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    Edina, Minnesota, 55435

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    Elkhart, Indiana, 46514

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    Elmira, New York, 14905

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    Everett, Washington, 98201

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    Farmington, Connecticut, 06030

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    Fayetteville, Alaska, 72703

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    Flint, Michigan, 48532

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    Fort Lauderdale, Florida, 33308

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    Fort Smith, Arkansas, 72901

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    Fort Wayne, Indiana, 46805

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    Gainesville, Florida, 32608

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    Geneva, Illinois, 60134

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    Gilbert, Arizona, 85297

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    Grand Blanc, Michigan, 48439

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    Grapevine, Texas, 76051

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    Green Bay, Wisconsin, 54308

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    Greensburg, Pennsylvania, 15601

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    Hagerstown, Maryland, 21740

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    Hammond, Indiana, 46320

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    Harrisburg, Pennsylvania, 17111

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    Hartford, Connecticut, 06102

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    Hershey, Pennsylvania, 17033

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    Hoffman Estates, Illinois, 60169

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    Honolulu, Hawaii, 96813

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    Houston, Texas, 77030

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    Hudson, Florida, 34667

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    Huntington, West Virginia, 25701

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    Indianapolis, Indiana, 46250

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    Jacksonville, Florida, 32209

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    Johnson City, New York, 13790

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    Johnstown, Pennsylvania, 15905

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    Joliet, Illinois, 60435

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    Joplin, Missouri, 64804

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    Kalispell, Montana, 59901

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    Kansas City, Kansas, 66160

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    Kansas City, Missouri, 64114

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    Kettering, Ohio, 45429

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    Lafayette, Indiana, 47905

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    Lakeland, Florida, 33805

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    Lancaster, Pennsylvania, 17602

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    Langhorne, Pennsylvania, 19047

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    Las Vegas, Nevada, 89102

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    Lewiston, Maine, 04240

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    Lexington, Kentucky, 40504

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    Little Rock, Arkansas, 72205

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    Loma Linda, California, 92354

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    Mobile, Alabama, 36617

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    Mount Clemens, Michigan, 48043

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    Muncie, Indiana, 47303

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    Nashua, New Hampshire, 03060

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    Nashville, Tennessee, 37205

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    Newark, New Jersey, 07055

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    Norfolk, Virginia, 23507

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    Northridge, California, 91325

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    Oak Lawn, Illinois, 60453

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    Ocala, Florida, 34471

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    Omaha, Nebraska, 68198

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    Orlando, Florida, 32806

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    Overland Park, Kansas, 66209

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    Owensboro, Kentucky, 42303

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    Parker, Colorado, 80138

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    Peoria, Illinois, 61614

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    Philadelphia, Pennsylvania, 19140

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    Pittsburgh, Pennsylvania, 15240

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    Portland, Oregon, 97225

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    Racine, Wisconsin, 53405

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    Raleigh, North Carolina, 27609

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    Reno, Nevada, 89503

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    Richmond, Virginia, 23320

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    Rock Island, Illinois, 61201

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    Stockton, California, 95204

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    Stuart, Florida, 34996

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    Summit, New Jersey, 07902

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    Takoma Park, Maryland, 20912

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    Temple, Texas, 76508

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    Urbana, Illinois, 61801

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    Utica, New York, 13501

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    Valhalla, New York, 10595

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    Vero Beach, Florida, 32960

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    Virginia Beach, Virginia, 23454

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    Warren, Michigan, 48093

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    Washington D.C., District of Columbia, 20010

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    Waukesha, Wisconsin, 53188

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    Wellington, Florida, 33449

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    Wilmington, North Carolina, 28402

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    Winchester, Virginia, 22601

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    Winter Haven, Florida, 33881

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    Worcester, Massachusetts, 01606

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    Wyoming, Michigan, 49519

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    Youngstown, Ohio, 44501

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Puerto Rico1 site

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    Rio Piedras, 00924

Other trials in Puerto Rico

About this study

Official title: The TRANSLATE-ACS Study: Treatment With ADP Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome

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.

Being tested
ADP receptor inhibitors
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADP receptor inhibitorsDrug

    Dosage regimen as determined by the treating physician.

Study groups in NCT01088503
Study groupRoleWhat they receive
ADP receptor inhibitor treatmentParticipants 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.
Receives: Drug: ADP receptor inhibitors

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Major Adverse Cardiovascular Events (MACE)

    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.

    Measured: Baseline through 12 months

  2. Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at 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.

    Measured: Day 0 (study enrollment)

  3. Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Pre-Procedure Hemoglobin

    Measured: Day 0 (study enrollment)

  4. Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Duke Coronary Artery Disease (CAD) Index

    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.

    Measured: Day 0 (study enrollment)

Secondary outcomes (5)

  1. Percentage of Participants With Cumulative Severe or Moderate Bleeding Events

    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.

    Measured: Baseline, 1, 6, 12 and 15 months

  2. 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

    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.

    Measured: Baseline through 12 months

  3. Percentage of Participants With MACE Over 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.

    Measured: Baseline through 1, 6 and 15 months

  4. Percentage of Participants With Definite or Probable Stent Thrombosis (ST) Events

    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.

    Measured: Baseline through 15 months

  5. Resource Use Patterns, Cumulative Total Medical Costs, and Cost Effectiveness

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

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
12,227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01088503
Sponsor's protocol ID
12549
Other IDs
H7T-US-B007
Acronym
TRANSLATE-ACS
Status last verified
Dec 2015
First submitted
15 Mar 2010
Last updated
29 Jan 2016
Data monitoring committee
Yes

Publications

  • Rymer JA, Kaltenbach LA, Doll JA, Messenger JC, Peterson ED, Wang TY. Safety of Dual-Antiplatelet Therapy After Myocardial Infarction Among Patients With Chronic Kidney Disease. J Am Heart Assoc. 2019 May 21;8(10):e012236. doi: 10.1161/JAHA.119.012236.

    PubMed 31070112

  • Warraich HJ, Kaltenbach LA, Fonarow GC, Peterson ED, Wang TY. Adverse Change in Employment Status After Acute Myocardial Infarction: Analysis From the TRANSLATE-ACS Study. Circ Cardiovasc Qual Outcomes. 2018 Jun;11(6):e004528. doi: 10.1161/CIRCOUTCOMES.117.004528.

    PubMed 29895612

  • Fanaroff AC, Kaltenbach LA, Peterson ED, Akhter MW, Effron MB, Henry TD, Wang TY. Antiplatelet Therapy Changes for Patients With Myocardial Infarction With Recurrent Ischemic Events: Insights Into Contemporary Practice From the TRANSLATE-ACS (Treatment With ADP Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome) Study. J Am Heart Assoc. 2018 Feb 8;7(4):e007982. doi: 10.1161/JAHA.117.007982.

    PubMed 29437596

  • Tisminetzky M, Wang TY, Gurwitz J, Kaltenbach LA, McManus D, Gore J, Peterson E, Goldberg RJ. Magnitude and Characteristics of Patients Who Survived an Acute Myocardial Infarction. J Am Heart Assoc. 2017 Sep 25;6(9):e006373. doi: 10.1161/JAHA.117.006373.

    PubMed 28947562

  • Guimaraes PO, Krishnamoorthy A, Kaltenbach LA, Anstrom KJ, Effron MB, Mark DB, McCollam PL, Davidson-Ray L, Peterson ED, Wang TY. Accuracy of Medical Claims for Identifying Cardiovascular and Bleeding Events After Myocardial Infarction : A Secondary Analysis of the TRANSLATE-ACS Study. JAMA Cardiol. 2017 Jul 1;2(7):750-757. doi: 10.1001/jamacardio.2017.1460.

    PubMed 28538984

  • 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.

    PubMed 28153990

  • 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):e003824. doi: 10.1161/JAHA.116.003824.

    PubMed 27792656

  • Fosbol 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):e003602. doi: 10.1161/CIRCINTERVENTIONS.115.003602.

    PubMed 27789517

  • 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):e002695. doi: 10.1161/JAHA.115.002695.

    PubMed 26811163

  • 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.

    PubMed 26680241

  • 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.

    PubMed 26386794

  • 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.

    PubMed 26093865

  • 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.

    PubMed 26038524

  • 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.

    PubMed 26025216

  • 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.

    PubMed 25995313

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome, run by Eli Lilly and Company at 186 sites in 2 countries.

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 4 inclusion and 1 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 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 186 sites in United States, Puerto Rico. 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?

Yes. Results are posted in the registry (first posted 29 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Major Adverse Cardiovascular Events (MACE) (time frame: Baseline through 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01088503, which also lists 19 linked publications.

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 29 Jan 2016.

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