Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study (ARTEMIS)

September 30, 2019 updated by: AstraZeneca
Current patterns of P2Y12 receptor inhibitor use provide an excellent opportunity to test the impact of copayment reduction on clinician choice of medication, patient adherence, and clinical outcomes. The ARTEMIS trial is a practical multicenter, cluster- randomized clinical trial that will assess the impact of copayment reduction by equalizing the copayment of clopidogrel and ticagrelor. ARTEMIS will assess prescribing patterns, patient medication adherence, and clinical outcomes up to one year. We hypothesize that reducing out--of--pocket cost for P2Y12 receptor inhibitor will lead to improved adherence. Additionally, copayment reduction of both generic and brand antiplatelet agents may lead to a reduction in MACE risk. This is in part due to greater adherence to an evidence--based secondary prevention medication. Additionally the reduction in MACE may reflect greater selection of a more potent antiplatelet agent that has been shown to reduce MACE in randomized clinical trials, as provider choice of antiplatelet therapy will be primarily driven by risk- benefit assessment rather than the cost burden to the patient.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

ARTEMIS is a prospective, cluster-randomized clinical trial that will evaluate whether patient copayment elimination significantly influences antiplatelet therapy selection and long-term adherence, as well as patient outcomes and overall cost of care after acute myocardial infarction. Approximately 11,000 patients with ST-elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) will be enrolled at the approximately 300 hospitals in this study. Study sites selected for ARTEMIS will be geographically diverse, and will represent a diversity of hospital types and capabilities (e.g., teaching hospital, community hospital, etc). After institutional review board (IRB) approval of the study, each hospital will be randomized into either the intervention arm or the control arm. Hospitals randomized to the intervention arm will have the opportunity to offer enrolled patients either clopidogrel (generic P2Y12 receptor inhibitor option) or ticagrelor (brand P2Y12 receptor inhibitor option) without patient contribution to copayment in the next 12 months after the index MI discharge. Hospitals in the control arm will provide care per usual clinical routine. Notably, for both intervention and control arms, all patient management decisions (including the choice of antiplatelet therapy) are completely at the discretion of the care providers. Duration of antiplatelet therapy will also be at the discretion of care providers. All enrolled patients will be followed up to 15 months after index MI discharge to collect data on longitudinal treatment patterns and outcomes. Primary and secondary endpoints will be assessed at 12 months. An additional three months of follow up will assess for antiplatelet persistence and clinical events after discontinuation of the copayment intervention. Centralized follow-up will be conducted every 3 months via telephone or web-based contact.

Study Type

Interventional

Enrollment (Actual)

11001

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Caguas, Puerto Rico, 00725
        • Research Site
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Research Site
      • Huntsville, Alabama, United States, 35613
        • Research Site
      • Mobile, Alabama, United States, 36608
        • Research Site
      • Mobile, Alabama, United States, 36617
        • Research Site
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Research Site
    • Arizona
      • Cottonwood, Arizona, United States, 86326
        • Research Site
      • Flagstaff, Arizona, United States, 86001
        • Research Site
      • Phoenix, Arizona, United States, 85008
        • Research Site
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Research Site
      • Fort Smith, Arkansas, United States, 72901
        • Research Site
      • Jonesboro, Arkansas, United States, 72401
        • Research Site
      • Little Rock, Arkansas, United States, 72211
        • Research Site
    • California
      • Escondido, California, United States, 92025
        • Research Site
      • Huntington Beach, California, United States, 92648
        • Research Site
      • Loma Linda, California, United States, 92354
        • Research Site
      • Los Angeles, California, United States, 90048
        • Research Site
      • Los Angeles, California, United States, 90095
        • Research Site
      • Northridge, California, United States, 91328
        • Research Site
      • Pasadena, California, United States, 91105
        • Research Site
      • Riverside, California, United States, 92501
        • Research Site
      • Salinas, California, United States, 93901
        • Research Site
      • Stockton, California, United States, 95210
        • Research Site
      • Thousand Oaks, California, United States, 91360
        • Research Site
      • Torrance, California, United States, 90505-5073
        • Research Site
      • Vista, California, United States, 92083
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
      • Aurora, Colorado, United States, 80012
        • Research Site
      • Colorado Springs, Colorado, United States, 80907
        • Research Site
      • Denver, Colorado, United States, 80204
        • Research Site
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Research Site
      • Danbury, Connecticut, United States, 6810
        • Research Site
      • New Haven, Connecticut, United States, 06519
        • Research Site
      • Stamford, Connecticut, United States, 06904
        • Research Site
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Research Site
      • Bradenton, Florida, United States, 34205
        • Research Site
      • Bradenton, Florida, United States, 34209
        • Research Site
      • Daytona Beach, Florida, United States, 32114
        • Research Site
      • Gainesville, Florida, United States, 32607
        • Research Site
      • Hollywood, Florida, United States, 33021
        • Research Site
      • Hudson, Florida, United States, 34667
        • Research Site
      • Jacksonville, Florida, United States, 32207
        • Research Site
      • Jacksonville, Florida, United States, 32204
        • Research Site
      • Jacksonville, Florida, United States, 32216
        • Research Site
      • Jacksonville, Florida, United States, 32258
        • Research Site
      • Jacksonville Beach, Florida, United States, 32250
        • Research Site
      • Lakeland, Florida, United States, 33805
        • Research Site
      • Largo, Florida, United States, 33770
        • Research Site
      • Miami, Florida, United States, 33133
        • Research Site
      • Ocala, Florida, United States, 34474
        • Research Site
      • Orlando, Florida, United States, 32803
        • Research Site
      • Panama City, Florida, United States, 32401
        • Research Site
      • Pensacola, Florida, United States, 32501
        • Research Site
      • Pensacola, Florida, United States, 32504
        • Research Site
      • Safety Harbor, Florida, United States, 34695
        • Research Site
      • Saint Petersburg, Florida, United States, 33713
        • Research Site
      • Saint Petersburg, Florida, United States, 33709
        • Research Site
      • Saint Petersburg, Florida, United States, 33701
        • Research Site
      • Sarasota, Florida, United States, 34239
        • Research Site
      • Tallahassee, Florida, United States, 32308
        • Research Site
      • Tampa, Florida, United States, 33607
        • Research Site
      • Tampa, Florida, United States, 33613
        • Research Site
      • Winter Haven, Florida, United States, 33881
        • Research Site
    • Georgia
      • Athens, Georgia, United States, 30606
        • Research Site
      • Atlanta, Georgia, United States, 30342
        • Research Site
      • Atlanta, Georgia, United States, 30303
        • Research Site
      • Augusta, Georgia, United States, 30912
        • Research Site
      • Cumming, Georgia, United States, 30041
        • Research Site
      • Lawrenceville, Georgia, United States, 30045
        • Research Site
      • Macon, Georgia, United States, 31217
        • Research Site
      • Macon, Georgia, United States, 31210
        • Research Site
      • Marietta, Georgia, United States, 30060
        • Research Site
      • Suwanee, Georgia, United States, 30024
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Research Site
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Research Site
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Research Site
      • Belleville, Illinois, United States, 62226
        • Research Site
      • Chicago, Illinois, United States, 60612
        • Research Site
      • Chicago, Illinois, United States, 60637
        • Research Site
      • Joliet, Illinois, United States, 60435
        • Research Site
      • Peoria, Illinois, United States, 61614
        • Research Site
      • Rockford, Illinois, United States, 61107
        • Research Site
      • Rockford, Illinois, United States, 61103
        • Research Site
      • Springfield, Illinois, United States, 62701
        • Research Site
      • Urbana, Illinois, United States, 51801
        • Research Site
    • Indiana
      • Bloomington, Indiana, United States, 47403
        • Research Site
      • Englewood, Indiana, United States, 7631
        • Research Site
      • Indianapolis, Indiana, United States, 46237
        • Research Site
      • Indianapolis, Indiana, United States, 46250
        • Research Site
      • Indianapolis, Indiana, United States, 46290
        • Research Site
      • Muncie, Indiana, United States, 47303
        • Research Site
      • Munster, Indiana, United States, 46321
        • Research Site
      • Richmond, Indiana, United States, 47375
        • Research Site
      • South Bend, Indiana, United States, 46601
        • Research Site
      • Valparaiso, Indiana, United States, 46383
        • Research Site
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Research Site
      • Iowa City, Iowa, United States, 52242
        • Research Site
      • West Des Moines, Iowa, United States, 50266
        • Research Site
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Research Site
      • Louisville, Kentucky, United States, 40202
        • Research Site
      • Louisville, Kentucky, United States, 40205
        • Research Site
      • Louisville, Kentucky, United States, 40292
        • Research Site
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Research Site
      • Bossier City, Louisiana, United States, 71111
        • Research Site
      • New Orleans, Louisiana, United States, 70121
        • Research Site
      • Shreveport, Louisiana, United States, 71103
        • Research Site
    • Maine
      • Rockport, Maine, United States, 04856
        • Research Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Research Site
      • Baltimore, Maryland, United States, 21229
        • Research Site
      • Baltimore, Maryland, United States, 21215
        • Research Site
      • Bethesda, Maryland, United States, 20814
        • Research Site
      • Clinton, Maryland, United States, 20735
        • Research Site
      • Columbia, Maryland, United States, 21044
        • Research Site
      • Rockville, Maryland, United States, 20850
        • Research Site
      • Salisbury, Maryland, United States, 21804
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 2215
        • Research Site
      • Boston, Massachusetts, United States, 02118
        • Research Site
      • Brighton, Massachusetts, United States, 2135
        • Research Site
      • Hyannis, Massachusetts, United States, 02601
        • Research Site
      • Worcester, Massachusetts, United States, 1655
        • Research Site
    • Michigan
      • Alpena, Michigan, United States, 49707
        • Research Site
      • Ann Arbor, Michigan, United States, 48109
        • Research Site
      • Bay City, Michigan, United States, 48708
        • Research Site
      • Detroit, Michigan, United States, 48202
        • Research Site
      • Detroit, Michigan, United States, 48236
        • Research Site
      • Flint, Michigan, United States, 48532
        • Research Site
      • Grand Blanc, Michigan, United States, 48439
        • Research Site
      • Grand Rapids, Michigan, United States, 49503
        • Research Site
      • Jackson, Michigan, United States, 39216
        • Research Site
      • Marquette, Michigan, United States, 49855
        • Research Site
      • Mount Clemens, Michigan, United States, 48043
        • Research Site
      • Petoskey, Michigan, United States, 49770
        • Research Site
      • Pontiac, Michigan, United States, 48341
        • Research Site
      • Saginaw, Michigan, United States, 48602
        • Research Site
      • Saint Joseph, Michigan, United States, 49085
        • Research Site
      • Southfield, Michigan, United States, 48075
        • Research Site
      • Warren, Michigan, United States, 48093
        • Research Site
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Research Site
      • Minneapolis, Minnesota, United States, 55407
        • Research Site
      • Saint Cloud, Minnesota, United States, 56303
        • Research Site
      • Saint Paul, Minnesota, United States, 55101
        • Research Site
      • Saint Paul, Minnesota, United States, 55102
        • Research Site
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Research Site
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • Research Site
      • Fenton, Missouri, United States, 63026
        • Research Site
      • Joplin, Missouri, United States, 64804
        • Research Site
      • Kansas City, Missouri, United States, 64114
        • Research Site
      • Kansas City, Missouri, United States, 64111
        • Research Site
      • North Kansas City, Missouri, United States, 64116
        • Research Site
      • Saint Charles, Missouri, United States, 63301
        • Research Site
      • Saint Louis, Missouri, United States, 63110
        • Research Site
      • Saint Louis, Missouri, United States, 63136
        • Research Site
      • Saint Louis, Missouri, United States, 63117
        • Research Site
      • Saint Louis, Missouri, United States, 63128
        • Research Site
      • Saint Louis, Missouri, United States, 63131-2374
        • Research Site
      • Saint Louis, Missouri, United States, 63367
        • Research Site
    • Montana
      • Billings, Montana, United States, 59101
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Research Site
      • Lincoln, Nebraska, United States, 68526
        • Research Site
      • Omaha, Nebraska, United States, 68131
        • Research Site
      • Omaha, Nebraska, United States, 68105
        • Research Site
      • Omaha, Nebraska, United States, 68154
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Research Site
      • Reno, Nevada, United States, 89502
        • Research Site
      • Reno, Nevada, United States, 89503
        • Research Site
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Research Site
      • Flemington, New Jersey, United States, 08822
        • Research Site
      • Haddon Heights, New Jersey, United States, 08035
        • Research Site
      • Haddon Heights, New Jersey, United States, 8035
        • Research Site
      • Moorestown, New Jersey, United States, 08057
        • Research Site
      • Newark, New Jersey, United States, 07102
        • Research Site
      • Paterson, New Jersey, United States, 07503
        • Research Site
      • Pomona, New Jersey, United States, 08240
        • Research Site
      • Ridgewood, New Jersey, United States, 07450
        • Research Site
      • Teaneck, New Jersey, United States, 07666
        • Research Site
      • Voorhees, New Jersey, United States, 08043
        • Research Site
    • New York
      • Albany, New York, United States, 12205
        • Research Site
      • Cooperstown, New York, United States, 13326
        • Research Site
      • Johnson City, New York, United States, 13790
        • Research Site
      • New York, New York, United States, 10029
        • Research Site
      • Poughkeepsie, New York, United States, 12601
        • Research Site
      • Rochester, New York, United States, 14621-3001
        • Research Site
      • Schenectady, New York, United States, 12308
        • Research Site
      • Staten Island, New York, United States, 10310
        • Research Site
      • Stony Brook, New York, United States, 11794
        • Research Site
      • Utica, New York, United States, 13501
        • Research Site
      • Valhalla, New York, United States, 10595
        • Research Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Research Site
      • Durham, North Carolina, United States, 27710
        • Research Site
      • Gastonia, North Carolina, United States, 28054
        • Research Site
      • High Point, North Carolina, United States, 27262
        • Research Site
      • Lumberton, North Carolina, United States, 28358
        • Research Site
      • Morehead City, North Carolina, United States, 28557
        • Research Site
      • Pinehurst, North Carolina, United States, 28374
        • Research Site
      • Raleigh, North Carolina, United States, 27607
        • Research Site
      • Raleigh, North Carolina, United States, 27610
        • Research Site
      • Wilmington, North Carolina, United States, 28403
        • Research Site
      • Winston-Salem, North Carolina, United States, 27104
        • Research Site
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • Research Site
    • Ohio
      • Canton, Ohio, United States, 447018
        • Research Site
      • Cincinnati, Ohio, United States, 45267
        • Research Site
      • Cleveland, Ohio, United States, 44106
        • Research Site
      • Dayton, Ohio, United States, 45406
        • Research Site
      • Kettering, Ohio, United States, 45429
        • Research Site
      • Middleburg Heights, Ohio, United States, 44130
        • Research Site
      • Toledo, Ohio, United States, 43615
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Research Site
      • Oklahoma City, Oklahoma, United States, 73120
        • Research Site
    • Oregon
      • Bend, Oregon, United States, 97701
        • Research Site
      • Portland, Oregon, United States, 97062
        • Research Site
      • Tualatin, Oregon, United States, 97062
        • Research Site
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Research Site
      • Allentown, Pennsylvania, United States, 18103
        • Research Site
      • Camp Hill, Pennsylvania, United States, 17011
        • Research Site
      • Chambersburg, Pennsylvania, United States, 17201
        • Research Site
      • Danville, Pennsylvania, United States, 17822
        • Research Site
      • Doylestown, Pennsylvania, United States, 18901
        • Research Site
      • Lancaster, Pennsylvania, United States, 17603
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19102
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15232
        • Research Site
      • Sayre, Pennsylvania, United States, 18840
        • Research Site
      • Scranton, Pennsylvania, United States, 18508
        • Research Site
      • Sellersville, Pennsylvania, United States, 18960
        • Research Site
      • West Reading, Pennsylvania, United States, 19611
        • Research Site
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Research Site
      • York, Pennsylvania, United States, 17403
        • Research Site
      • York, Pennsylvania, United States, 17405
        • Research Site
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Research Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Research Site
      • Charleston, South Carolina, United States, 29425
        • Research Site
      • Charleston, South Carolina, United States, 29401
        • Research Site
      • Columbia, South Carolina, United States, 29204
        • Research Site
      • Columbia, South Carolina, United States, 29203
        • Research Site
      • Greenwood, South Carolina, United States, 29646
        • Research Site
      • West Columbia, South Carolina, United States, 29169
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Research Site
    • Tennessee
      • Jackson, Tennessee, United States, 38301
        • Research Site
      • Knoxville, Tennessee, United States, 37934
        • Research Site
      • Memphis, Tennessee, United States, 38120
        • Research Site
      • Memphis, Tennessee, United States, 38104
        • Research Site
      • Oak Ridge, Tennessee, United States, 37830
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site
      • Houston, Texas, United States, 77074
        • Research Site
      • New Braunfels, Texas, United States, 78130
        • Research Site
      • Palestine, Texas, United States, 75801
        • Research Site
      • Plano, Texas, United States, 75093
        • Research Site
      • Round Rock, Texas, United States, 78665
        • Research Site
      • San Antonio, Texas, United States, 78201
        • Research Site
      • Temple, Texas, United States, 76508
        • Research Site
      • Waco, Texas, United States, 76712
        • Research Site
      • Webster, Texas, United States, 77598
        • Research Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Research Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Research Site
      • Lynchburg, Virginia, United States, 24501
        • Research Site
      • Norfolk, Virginia, United States, 23507
        • Research Site
      • Richmond, Virginia, United States, 23229
        • Research Site
      • Roanoke, Virginia, United States, 24014
        • Research Site
      • Winchester, Virginia, United States, 22601
        • Research Site
    • Washington
      • Puyallup, Washington, United States, 98372
        • Research Site
      • Renton, Washington, United States, 98055
        • Research Site
      • Spokane, Washington, United States, 99204
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Research Site
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Research Site
      • La Crosse, Wisconsin, United States, 54601
        • Research Site
      • Milwaukee, Wisconsin, United States, 53226
        • Research Site
      • Milwaukee, Wisconsin, United States, 53215
        • Research Site
      • Milwaukee, Wisconsin, United States, 53211
        • Research Site
      • Racine, Wisconsin, United States, 53405
        • Research Site
      • Waukesha, Wisconsin, United States, 53188
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients are eligible to be included in the study if they meet all of the following criteria:

  • are ≥ 18 years of age
  • have been diagnosed with STEMI or NSTEMI during the index hospitalization
  • be treated with a P2Y12 receptor inhibitor at the time of enrollment
  • have U.S. based health insurance coverage with prescription drug benefit
  • have been fully informed and are able to provide written consent for longitudinal follow-up

Exclusion Criteria:

Patients are excluded if they meet any of the following criteria:

  • have a history of prior intracranial hemorrhage
  • have any contraindications to P2Y12 receptor inhibitor therapy at discharge
  • involvement in another research study that specifies the type and duration of P2Y12 receptor inhibitor use within the next 12 months.
  • have a life expectancy of less than one year
  • have plans to move outside the US in the next year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Copayment Intervention Arm
Sites in the intervention arm will provide patients with a study voucher card to offset any patient copayments or medication card for the filling of any prescriptions of clopidogrel or ticagrelor.
Study voucher card to offset any patient copayments or medication costs for the filling of any prescriptions of clopidogrel or ticagrelor
No Intervention: Usual Care Arm
For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kaplan-Meier Cumulative Incidence Rate of Major Adverse Cardiovascular Events
Time Frame: 12 months
To determine if patient copayment reduction leads to lower risk of MACE (composite of death, MI, and stroke) at 1 year after discharge.
12 months
Percentage of Patients With Long Term Non-persistence to P2Y12 Receptor Inhibitor
Time Frame: 12 months
To determine if patient copayment reduction leads to higher long-term persistence of any P2Y12 receptor inhibitor at 1 year after discharge.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
P2Y12 Receptor Inhibitor Selection
Time Frame: 12 months
To evaluate whether reducing patient copayments for both generic and brand P2Y12 receptor inhibitor options affects medication selection at discharge.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Tracy Wang, MD, MHS, MSc, Duke University
  • Study Chair: Eric Peterson, MD, MPH, FAHA, FACC, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2015

Primary Completion (Actual)

October 23, 2017

Study Completion (Actual)

October 23, 2017

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

April 1, 2015

First Posted (Estimate)

April 2, 2015

Study Record Updates

Last Update Posted (Actual)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

September 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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