EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction (EVOLVE-MI)

October 3, 2025 updated by: Amgen

EVOLVE-MI: A Pragmatic Randomized Multicenter Trial of EVOLocumab Administered Very Early to Reduce the Risk of Cardiovascular Events in Patients Hospitalized With Acute Myocardial Infarction

The primary objective of this study is to evaluate the effectiveness of early treatment with evolocumab plus routine lipid management vs routine lipid management alone when administered in the acute setting to reduce myocardial infarction, ischemic stroke, arterial revascularization, and all-cause death in subjects hospitalized for an acute myocardial infarction (non-ST-segment elevation myocardial infarction [NSTEMI] and ST-segment elevation myocardial infarction [STEMI]).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6019

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05652-900
        • Hospital Israelita Albert Einstein
      • São Paulo, Brazil, 05403-000
        • Instituto do coracao da Faculdade de Medicina da Universidade de Sao Paulo - InCor
    • Acre
      • Rio Branco, Acre, Brazil, 69900785
        • Clínica Silvestre Santé
    • Espírito Santo
      • Linhares, Espírito Santo, Brazil, 29900010
        • Instituto Cardiovascular de Linhares
    • Goiás
      • Ipiranga Goiânia, Goiás, Brazil, 74453-200
        • Hospital Ruy Azeredo
      • Ipiranga Goiânia, Goiás, Brazil, 74453-200
        • Hospital Universitário São Francisco na Providência de Deus
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30140-073
        • Hospital Madre Teresa
      • Belo Horizonte, Minas Gerais, Brazil, 30140-073
        • Hospital Universitário Ciências Médicas de Belo Horizonte
      • Poços de Caldas, Minas Gerais, Brazil, 37706-106
        • Hospital do Coracao de Pocos de Caldas CEC servicos medicos
    • Pernambuco
      • Casa Forte, Pernambuco, Brazil, 52061-540
        • Ps Cardiologico de PE - Procape
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59020-500
        • Instituto Atena de Pesquisa Clinica
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazil, 90620-001
        • Instituto de Cardiologia do Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
        • Centro de Pesquisa Clínica Associação Hospitalar Moinhos de Vento
      • Porto Alegre, Rio Grande do Sul, Brazil, 90620-001
        • Santa Casa de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazil, 90840-440
        • Hospital Mae de Deus
      • São Paulo, Rio Grande do Sul, Brazil, 01323-900
        • Hospital Beneficência Portuguesa
    • Santa Catarina
      • Joinville, Santa Catarina, Brazil, 89204-250
        • Cmep-Centro Multidisciplinar Ensino e Pesq
      • Praia Comprida, Sao Jose, Santa Catarina, Brazil, 88103-450
        • Instituto de Cardiologia de Santa Catarina
    • Sergipe
      • Aracaju, Sergipe, Brazil, 49055-530
        • Centro de Pesquisa Clinica do Coracao
    • São Paulo
      • Campinas, São Paulo, Brazil, 13060-080
        • Instituto de Pesquisa clinica de Campinas
      • Marília, São Paulo, Brazil, 90840-440
        • Irmandade da Santa Casa de Misericórdia de Marília
      • Presidente Prudente, São Paulo, Brazil, 19050-680
        • Hospital Regional de Presidente Prudente
      • São Paulo, São Paulo, Brazil, 04012-909
        • Instituto Dante Pazanesse
  • Sweden
      • Alingsås, Sweden, 441 33
        • Alingsas lasarett
      • Gävle, Sweden, 801 88
        • Gavle Sjukhus
      • Jönköping, Sweden, 553 05
        • Länssjukhuset Ryhov
      • Karlskrona, Sweden, 371 85
        • Blekingesjukhuset Karlskrona
      • Linköping, Sweden, 581 85
        • Linköping University Hospital
      • Luleå, Sweden, 971 80
        • Sunderby Sjukhus
      • Lund, Sweden, 221 85
        • Skane Universitetssjukhus i Lund
      • Molndahl, Sweden, 431 80
        • Mölndals Sjukhus
      • Norrköping, Sweden, 601 82
        • Vrinnevisjukhuset, Norrkoeping
      • Stockholm, Sweden, 118 83
        • Södersjukhuset
      • Sundsvall, Sweden, 851 86
        • Sundsvalls sjukhus
      • Uppsala, Sweden, 751 85
        • Akademiska sjukhuset i Uppsala
      • Vaxjo, Sweden, 351 85
        • Centrallasarettet Växjö
      • Västerås, Sweden, 721 89
        • Västmanlands sjukhus Västerås
      • Östersund, Sweden, 831 83
        • Östersunds Sjukhus
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
      • Fairhope, Alabama, United States, 36532
        • Eastern Shore Research Institute
      • Huntsville, Alabama, United States, 35801-4317
        • Heart Center Research Llc
    • Arizona
      • Flagstaff, Arizona, United States, 86001
        • Northern Arizona Healthcare Corporation Cardiovascular Institute
      • Scottsdale, Arizona, United States, 85258
        • Scottsdale Healthcare at Shea - HonorHealth
      • Tucson, Arizona, United States, 85719
        • Pima Heart and Vascular Clinical Research
    • California
      • Concord, California, United States, 94520
        • John Muir Health and Cardiovascular Institute
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles
      • Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Healthcare System
      • Orange, California, United States, 92868
        • University of California-Irvine
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Bridgeport Hospital
      • Hartford, Connecticut, United States, 06106
        • Hartford Hospital
      • Stamford, Connecticut, United States, 06905
        • Cardiology Associates of Fairfield County PC
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Excel Medical Clinical Trials
      • Clearwater, Florida, United States, 33756
        • Clearwater Cardiovascular Consultants
      • Gainesville, Florida, United States, 32610
        • University of Florida at Gainesville
      • Jacksonville, Florida, United States, 32209
        • University of Florida and Shands Hospital
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando
      • Palm Beach Gardens, Florida, United States, 33410
        • Cardiology Partners Clinical Research Institute
      • Pensacola, Florida, United States, 32504
        • Ascension Sacred Heart
      • Pensacola, Florida, United States, 32501
        • Baptist Health Care
      • Safety Harbor, Florida, United States, 34695
        • Clearwater Cardiovascular Consultants
      • Tampa, Florida, United States, 33614
        • Tampa Cardiovascular Interventions and Research
      • Winter Park, Florida, United States, 32789
        • Clinical Site Partners Orlando dba Flourish Research
    • Idaho
      • Boise, Idaho, United States, 83712
        • Saint Lukes Boise Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Jesse Brown Veterans Affairs Medical Center
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials - Ravenswood
      • Park Ridge, Illinois, United States, 60068
        • Advocate Lutheran General Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Ascension Saint Vincent Heart Center
      • Richmond, Indiana, United States, 47374
        • Reid Physician Associates
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Hospital
      • Overland Park, Kansas, United States, 66211
        • Midwest Heart and Vascular Specialists
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Health - Jewish Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Grand Rapids, Michigan, United States, 49546
        • Healthy Heart Cardiology
      • Lansing, Michigan, United States, 48912
        • Sparrow Clinical Research Institute
      • Mount Clemens, Michigan, United States, 48043
        • McLaren Macomb Research Services
      • Petoskey, Michigan, United States, 49770
        • McLaren Northern Michigan Hospital
      • Rochester Hills, Michigan, United States, 48307
        • Advanced Cardiology Associates
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Saint Marys Medical Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Jackson Heart
      • Tupelo, Mississippi, United States, 38801
        • Cardiology Associates of North Mississippi
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Lukes Hospital of Kansas City
      • North Kansas City, Missouri, United States, 64116
        • North Kansas City Hospital
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Advanced Heart Care LLC
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Newark, New Jersey, United States, 07102
        • Saint Michaels Medical Center
    • New York
      • Bay Shore, New York, United States, 11706
        • South Shore University Hospital Northwell Health
      • New York, New York, United States, 10065
        • New York Presbyterian-Weill Cornell Medical Center
      • Poughkeepsie, New York, United States, 12601
        • Hudson Valley Cardiovascular Practice PC
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Staten Island, New York, United States, 10310
        • Richmond University Medical Center
      • Stony Brook, New York, United States, 11794
        • Stony Brook Medicine
      • The Bronx, New York, United States, 10580
        • Montefiore Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Cardiology
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Heart and Vascular Institute Presbyterian Medical Center
      • Greensboro, North Carolina, United States, 27401
        • Moses H Cone Memorial Hospital
    • Ohio
      • Canton, Ohio, United States, 44710
        • Aultman Hospital
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center
      • Zanesville, Ohio, United States, 43701
        • Genesis HealthCare System
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Ascension Saint John Bartlesville
      • Tulsa, Oklahoma, United States, 74104
        • Ascension Saint John Tulsa
    • Pennsylvania
      • Chambersburg, Pennsylvania, United States, 17201
        • Wellspan Chambersburg Hospital
      • Lancaster, Pennsylvania, United States, 17603
        • Lancaster General Hospital/The Heart Group of Lancaster
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital Tower Health
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
      • Warwick, Rhode Island, United States, 02886
        • Kent Hospital
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Prisma Upstate and Midlands Greenville Hospital System
      • Greenville, South Carolina, United States, 29607
        • Upstate Cardiology
    • Tennessee
      • Knoxville, Tennessee, United States, 37934
        • Tennova Healthcare-Turkey Creek Medical Center
      • Nashville, Tennessee, United States, 37232-8802
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37205
        • Ascension Saint Thomas Nashville
      • Oak Ridge, Tennessee, United States, 37830
        • Parkway Cardiology Associates
      • Powell, Tennessee, United States, 37849
        • Cardiovascular Research of Knoxville North Knoxville Medical Center
    • Texas
      • Austin, Texas, United States, 78705
        • Ascension Texas Cardiovascular
      • Kyle, Texas, United States, 78640
        • Ascension Texas Cardiovascular Kyle
    • Virginia
      • Midlothian, Virginia, United States, 23114
        • Bon Secours St Marys Hospital Richmond
      • Richmond, Virginia, United States, 23225
        • Chippenham Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Saint Lukes Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Hospitalized for primary reason of NSTEMI or STEMI due to presumed atherosclerotic disease

Exclusion Criteria:

  • Participants requiring invasive hemodynamic and/or vasopressor/inotropic support at the time of screening
  • Participants with elevated biomarkers of myocardial injury due to secondary/nonatherosclerotic etiology (eg, sepsis, atrial fibrillation, vasospasm, decompensated heart failure, uncontrolled hypertension, stress induced cardiomyopathy)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Evolocumab + Routine Lipid Management
Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management.
Drug: Evolocumab
Evolocumab will be provided as a single-dose, prefilled autoinjector pen (AI/pen) for fixed dose subcutaneous (SC) injection.
Other Names:
  • Repatha
  • AMG 145
Drug: Routine Lipid Management
Routine lipid management therapies will be administered at the discretion of the investigator per SoC.
Active Comparator: Routine Lipid Management
Participants will receive routine lipid management per standard of care (SoC).
Drug: Routine Lipid Management
Routine lipid management therapies will be administered at the discretion of the investigator per SoC.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death
Time Frame: From Baseline to End of Study (Approximately 3.5 Years)
From Baseline to End of Study (Approximately 3.5 Years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and cardiovascular death
Time Frame: From Baseline to End of Study (Approximately 3.5 Years)
From Baseline to End of Study (Approximately 3.5 Years)
Time to the First Occurrence of the Composite of Myocardial Infarction, Ischemic Stroke, any Arterial Revascularization Procedure, and All-Cause Death
Time Frame: From Baseline to End of Study (Approximately 3.5 Years)
From Baseline to End of Study (Approximately 3.5 Years)
Total Myocardial Infarctions Events
Time Frame: From Baseline to End of Study (Approximately 3.5 Years)
From Baseline to End of Study (Approximately 3.5 Years)
Total Arterial Revascularization Procedures
Time Frame: From Baseline to End of Study (Approximately 3.5 Years)
From Baseline to End of Study (Approximately 3.5 Years)
Total Ischemic Strokes
Time Frame: From Baseline to End of Study (Approximately 3.5 Years)
From Baseline to End of Study (Approximately 3.5 Years)
Time to Cardiovascular Death
Time Frame: From Baseline to End of Study (Approximately 3.5 Years)
From Baseline to End of Study (Approximately 3.5 Years)
Time to All-Cause Death
Time Frame: From Baseline to End of Study (Approximately 3.5 Years)
From Baseline to End of Study (Approximately 3.5 Years)
Percentage Change From Baseline in LDL-C
Time Frame: From Baseline to Week 12
Percent LDL-C change from baseline to 12 weeks in a subset of approximately 300 randomly selected participants.
From Baseline to Week 12
Percentage Change From Baseline in LDL-C
Time Frame: From Baseline to Week 52
Percent LDL-C change from baseline to 52 weeks in a subset of approximately 300 randomly selected participants.
From Baseline to Week 52
Total Ischemia-driven Coronary Revascularization Procedures
Time Frame: From Baseline to End of Study (Approximately 3.5 Years)
From Baseline to End of Study (Approximately 3.5 Years)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Colorado Prevention Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

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.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 29, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20190184
  • 2021-005272-19 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings