HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial (HIP ATTACK-2)

September 25, 2025 updated by: Population Health Research Institute

HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 (HIP ATTACK-2) Trial

The HIP ATTACK-2 trial is a multicentre, international, parallel group randomized controlled trial to determine whether accelerated surgery for hip fracture in patients with acute myocardial injury is superior to standard care in reducing death at 90 days after randomization. The trial will also assess secondary outcomes at 90 days after randomization: inability to independently walk 3 metres, time to first mobilization (first standing and first full weight bear), composite and individual assessment of major complications (e.g., mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke), delirium, length of stay, pain, and quality of life.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1100

Phase

  • Not Applicable

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 Locations

  • Australia
    • New South Wales
      • New Lambton Heights, New South Wales, Australia, 2305
  • Belgium
    • Brussels Capital
      • Woluwe-Saint-Lambert, Brussels Capital, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint Luc - University Catholic of Louvain
        • Principal Investigator:
          • Patricia Lavand'homme, MD
        • Contact:
  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05403010
        • Recruiting
        • University of Sao Paulo
        • Contact:
        • Principal Investigator:
          • Kodi Kojima, MD
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • University of Alberta Hospital
        • Contact:
        • Principal Investigator:
          • Mike Jacka, MD
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Recruiting
        • St. Joseph's Healthcare Hamilton
        • Contact:
        • Principal Investigator:
          • Flavia Borges, MD
      • Hamilton, Ontario, Canada, L8V 1C3
        • Recruiting
        • Juravinski Hospital
        • Principal Investigator:
          • Ameen Patel, MD
        • Contact:
      • London, Ontario, Canada, N6A 5W9
      • Markham, Ontario, Canada, L3P 7P3
        • Recruiting
        • Markham Stouffville Hospital
        • Principal Investigator:
          • Steve McMahon, MD
        • Contact:
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • Ottawa General Hospital
        • Contact:
        • Principal Investigator:
          • Robert Feibel, MD
    • Quebec
  • Chile
      • Santiago, Chile, 7520378
        • Recruiting
        • Clinica Santa Maria
        • Contact:
        • Principal Investigator:
          • David Torres, MD
    • RM
      • Santiago, RM, Chile, 83300024
        • Recruiting
        • Pontifica Universidad Catolica de Chile
        • Contact:
        • Principal Investigator:
          • Fernando Altermatt, MD
  • Finland
      • Lappeenranta, Finland, 53130
        • Recruiting
        • South Karelia Central Hospital
        • Contact:
        • Principal Investigator:
          • Lauri Halonen, MD
      • Tampere, Finland, 33521
        • Recruiting
        • Tampere University Hospital
        • Contact:
        • Principal Investigator:
          • Aleksi Reito, MD
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital
        • Contact:
        • Principal Investigator:
          • Christian Fang, MD
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560024
    • Kerala
      • Alappuzha, Kerala, India, 688005
      • Trivandrum, Kerala, India, 695011
        • Recruiting
        • Government Medical College
        • Principal Investigator:
          • Prem Menon, MD
        • Contact:
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • Recruiting
        • All India Institute Of Medical Sciences (AIIMS)
        • Contact:
        • Principal Investigator:
          • Vijay Sharma, MD
    • Puducherry
      • Puducherry, Puducherry, India, 605006
        • Recruiting
        • JIPMER
        • Contact:
        • Principal Investigator:
          • Adinarayanan Sethuramachandran, MD
        • Principal Investigator:
          • Deep Sharma, MD
  • Italy
      • Genova, Italy, 16128
        • Recruiting
        • Galliera Hospital
        • Contact:
        • Principal Investigator:
          • Maria Laura Raimondo, MD
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele S.r.l.
        • Contact:
        • Principal Investigator:
          • Vincenzo Salini, MD
      • Milan, Italy, 20157
        • Recruiting
        • Ospedale Galeazzi SpA
        • Contact:
        • Principal Investigator:
          • Guiseppe De Blasio, MD
    • Umbria
      • Perugia, Umbria, Italy, 06129
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University of Malaya Medical Centre
        • Principal Investigator:
          • Chew Yin Wang, MD
        • Contact:
  • Mexico
    • Chihuahua
      • Chihuahua City, Chihuahua, Mexico, 31000
        • Recruiting
        • Christus Muguerza del Parque
        • Contact:
        • Principal Investigator:
          • Edmundo Berumen, MD
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44410
        • Recruiting
        • Cruz Verde Guadalajara
        • Contact:
        • Principal Investigator:
          • Ricardo Madrigal, MD
  • Nepal
    • Bagmati
      • Lalitpur, Bagmati, Nepal, 44700
  • Netherlands
    • Overijssel
      • Deventer, Overijssel, Netherlands, 7416 SE
        • Recruiting
        • Deventer Hospital
        • Contact:
        • Principal Investigator:
          • Ydo Kleinlugtenbelt, MD
  • Pakistan
    • ICT
      • Islamabad, ICT, Pakistan, 44000
        • Recruiting
        • Shifa International Hospitals Ltd.
        • Contact:
        • Principal Investigator:
          • Aamir Nabi Nur, MD
      • Islamabad, ICT, Pakistan, 44000
    • KPK
      • Peshawar, KPK, Pakistan, 25000
        • Recruiting
        • Hayat Abad Medical Complex
        • Contact:
        • Principal Investigator:
          • Muhammad Arif, MD
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
      • Rawalpindi, Punjab Province, Pakistan, 46000
    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • Recruiting
        • Aga Khan University
        • Contact:
        • Principal Investigator:
          • Masood Umer, MD
      • Karachi, Sindh, Pakistan
        • Recruiting
        • Indus Hospital & Health Network
        • Contact:
        • Principal Investigator:
          • Syed Kamran Ahmed, MD
  • Poland
    • Malopolska
      • Myślenice, Malopolska, Poland, 32-400
        • Recruiting
        • SPZOZ Myslenice
        • Contact:
        • Principal Investigator:
          • Paweł Ślęczka, MD
  • Saudi Arabia
    • Riyadh Region
      • Riyadh, Riyadh Region, Saudi Arabia, 11211
        • Recruiting
        • King Faisal Specialist Hospital
        • Contact:
        • Principal Investigator:
          • Husam Alrumaih, MD
  • South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Recruiting
        • Groote Schuur Hospital
        • Contact:
        • Principal Investigator:
          • Sithombo Maqungo, MD
        • Principal Investigator:
          • Margot Flint, MD
      • Cape Town, Western Cape, South Africa, 7505
        • Recruiting
        • Stellenbosch University - Tygerberg Hospital
        • Contact:
        • Principal Investigator:
          • Sean Chetty, MD
  • Spain
      • Barcelona, Spain, 08830
        • Recruiting
        • Parc Sanitari Sant Joan de Deu
        • Contact:
        • Principal Investigator:
          • Juan Castellanos Robles, MD
        • Principal Investigator:
          • Pilar Aparicio Garcia, MD
    • Barcelona
      • Barcelona, Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Ernesto Guerra-Farfan, MD
      • Barcelona, Barcelona, Spain, 08029
        • Recruiting
        • Hospital Universitari Sagrat Cor
        • Principal Investigator:
          • Laura Ruiz-Villa, MD
        • Contact:
        • Principal Investigator:
          • Aamer Malik Khan, MD
      • Barcelona, Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic of Barcelona
        • Contact:
        • Principal Investigator:
          • Mariano Balaguer-Castro, MD
      • Barcelona, Barcelona, Spain, 08041
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jordi Martin Marcuello, MD
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Hospital Universitari Parc Tauli
        • Contact:
        • Principal Investigator:
          • Ferran Corcoll, MD
      • Sant Pere de Ribes, Barcelona, Spain, 08810
        • Recruiting
        • Hospital Sant Camil
        • Principal Investigator:
          • Alfred Dealbert, MD
        • Contact:
      • Terrassa, Barcelona, Spain, 08221
        • Recruiting
        • Hospital Universitario Mutua de Terrassa
        • Contact:
        • Principal Investigator:
          • Marti Bernaus, MD
    • Malaga
      • Marbella, Malaga, Spain, 29603
        • Recruiting
        • Hospital Costa del Sol
        • Contact:
        • Principal Investigator:
          • Enrique Guerado, MD
    • Valladolid
      • Valladolid, Valladolid, Spain, 47007
        • Recruiting
        • Hospital Clinico Universitario de Vallad
        • Contact:
        • Principal Investigator:
          • Hector Aguado, MD
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
    • California
      • Davis, California, United States, 95618
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale New Haven Hospital
        • Contact:
        • Principal Investigator:
          • Matthew Riedel, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University at Grady Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Roberto Hernandez Irizarry, MD
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Recruiting
        • Sinai Hospital of Baltimore
        • Principal Investigator:
          • Ronald Delanois, MD
        • Contact:
      • Baltimore, Maryland, United States, 20742
        • Recruiting
        • University of Maryland
        • Principal Investigator:
          • Gerard Slobogean, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
      • Burlington, Massachusetts, United States, 01805
        • Recruiting
        • Lahey Hospital and Medical Center
        • Contact:
        • Principal Investigator:
          • Andrew Marcantonio, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • Jaimo Ahn, MD
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Brandon Yuan, MD
    • Nebraska
    • Nevada
      • Las Vegas, Nevada, United States, 89102
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
    • New York
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
        • Principal Investigator:
          • Lauren Crocco, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Nicolas Piuzzi, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
        • Principal Investigator:
          • Zachary Working, MD
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • St. Luke's University Health Network
        • Contact:
        • Principal Investigator:
          • Douglas Lundy, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:
        • Principal Investigator:
          • Stephen Warner, MD
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Recruiting
        • University of Wisconsin
        • Contact:
        • Principal Investigator:
          • Christopher Domes, MD

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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. age ≥45 years;
  2. diagnosis of hip fracture during working hours with a low-energy mechanism requiring surgery;
  3. troponin elevation ( at least one troponin measurement above the upper limit of normal occurring from the time of hip fracture to the time of randomization); and
  4. informed consent.

Exclusion Criteria:

  1. taking a therapeutic dose of an anticoagulant for which no reversing agent is available and the anesthesiologist or surgeon believe surgery within 6 hours of eligibility criteria met would not be safe;
  2. patients on a therapeutic vitamin K antagonist with a history of heparin induced thrombocytopenia (HIT);
  3. patients with peri-prosthetic fracture, open fracture or bilateral fractures;
  4. patients requiring an emergency surgery for another reason (e.g., subdural hematoma);
  5. patients with acute myocardial infarction deemed to be clinically unstable, with a mechanical complication (i.e., acute papillary muscle rupture, ventricular septal defect), ST elevation myocardial infarction, or cardiogenic shock;
  6. patients refusing consent; or
  7. patients previously enrolled in HIP ATTACK-2.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard surgical care
Hip fracture repair and surgical care according to treating institution guidelines.
Experimental: Accelerated medical clearance and surgery
Accelerated medical clearance and targeted arrival to the operating room within 6 hours of eligibility criteria met.
Other: Accelerated medical clearance and surgery
Rapid medical clearance with targeted arrival to the operating room within 6 hours of eligibility criteria criteria met.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: Within 90 days post randomization
Death due to all causes
Within 90 days post randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability to independently walk 3 meters
Time Frame: Within 90 days post randomization
Ability to independently walk 3 meters (10 feet) or across a room without human assistance. Patients who require a cane or walker, but not human assistance, will be classified as able to walk independently. Patients who require assistance to get out of a chair, but can walk independently once they get up, will be classified as able to walk independently.
Within 90 days post randomization
Composite of major complications
Time Frame: Within 90 days post randomization
Composite includes vascular and nonvascular mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke.
Within 90 days post randomization
Vascular mortality
Time Frame: Within 90 days post randomization
Any death with a vascular cause and includes those deaths following a myocardial infarction, sudden cardiac arrest, stroke, cardiac revascularization procedure (i.e., percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery), heart failure, pulmonary embolus, cardiovascular hemorrhage, or deaths due to an unknown cause
Within 90 days post randomization
Nonvascular mortality
Time Frame: Within 90 days post randomization
Any death due to a clearly documented non-vascular cause.
Within 90 days post randomization
Myocardial Infarction
Time Frame: Within 90 days post randomization
Diagnosis of MI according to 4th universal definition of myocardial infarction
Within 90 days post randomization
Stroke
Time Frame: Within 90 days post randomization
Either - 1. a new focal neurological deficit thought to be vascular in origin with signs or symptoms lasting more than 24 hours or leading to death; or 2. a new focal neurological deficit thought to be vascular in origin with signs or symptoms lasting less 24 hours with a positive neuroimaging consistent with a stroke
Within 90 days post randomization
Time from randomization to hospital discharge
Time Frame: Within 90 days post randomization
Length of hospital stay from randomization to hospital discharge
Within 90 days post randomization
Moderate to severe pain
Time Frame: Within 7 days and 90 days post randomization
Moderate to severe pain is defined as any pain score ≥3 on 10 points scale.
Within 7 days and 90 days post randomization
Acute Congestive Heart Failure
Time Frame: Within 90 days post randomization

at least one clinical sign(s) or symptom(s) (e.g elevated jugular venous pressure, respiratory rales/crackles, crepitations, hypoxia, tachypnea or presence of S3) with at least one of the following:

  1. radiographic findings (i.e., vascular redistribution, interstitial pulmonary edema, or frank alveolar pulmonary edema) or point of care ultrasound findings (i.e., bilateral B-lines, bilateral pleural effusion, elevated jugular venous pressure, dilated inferior vena cava with respiratory variation less than 50%) OR
  2. heart failure treatment implemented with diuretics with documented clinical improvement.
Within 90 days post randomization
Delirium
Time Frame: Within 7 days and 90 days post randomization
  1. Patient meets the criteria for delirium on any in-person 3D-CAM or CAM administered; OR
  2. Positive history of delirium in the 7 days after randomization based on the review of hospital health records.
Within 7 days and 90 days post randomization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac revascularization procedure
Time Frame: Within 90 days post randomization
Revascularization procedures including coronary artery bypass graft or percutaneous coronary intervention surgery.
Within 90 days post randomization
Venous thromboembolism
Time Frame: Within 90 days post randomization
Venous pulmonary embolism or deep venous thrombosis
Within 90 days post randomization
Pulmonary embolism
Time Frame: Within 90 days post randomization

The diagnosis of PE requires any one of the following:

  1. A high probability ventilation/perfusion lung scan,
  2. An intraluminal filling defect of a segmental or larger artery on a helical CT scan,
  3. An intraluminal filling defect on pulmonary angiography, or
  4. A positive diagnostic test for DVT (e.g., positive compression ultrasound) and one of the following:

A. Non-diagnostic (i.e., low or intermediate probability) ventilation/perfusion lung scan B. Non-diagnostic (i.e., subsegmental defects or technically inadequate study) helical CT scan.
Within 90 days post randomization
Proximal deep venous thrombosis
Time Frame: Within 90 days post randomization

The diagnosis of proximal DVT requires:

  1. Thrombosis involving the popliteal vein or more proximal veins for leg DVT and axillary or more proximal veins for arm DVT, AND
  2. Evidence of vein thrombosis by any one of the following:

1. A persistent intraluminal filling defect on contrast venography, 2. Noncompressibility of one or more venous segments on B mode compression ultrasonography, or 3. A clearly defined intraluminal filling defect on contrast enhanced computed tomography.
Within 90 days post randomization
Infection
Time Frame: Within 90 days post randomization
Pathologic process caused by the invasion of normally sterile tissue or fluid or body cavity by pathogenic or potentially pathogenic organisms.
Within 90 days post randomization
Pneumonia
Time Frame: Within 90 days post randomization
Acute infection of the pulmonary parenchyma that is associated with at least one sign or symptom of lower respiratory acute infection (e.g., cough, pleuritic chest pain) or acute systemic illness (e.g., fever, chills, confusion, hypoxemia); accompanied by the presence of an acute infiltrate/consolidation on a chest radiograph or auscultatory findings consistent with pneumonia (such as crackles and/or localized rales) for which there is no other explanation.
Within 90 days post randomization
Bleeding
Time Frame: Within 90 days post randomization
Life threatening, major or critical organ bleeding
Within 90 days post randomization
Hip reoperation
Time Frame: Within 90 days post randomization
Any second surgical procedure undertaken on the fractured hip being followed in the study, for any reason (e.g. infection, implant failure, periprosthetic fracture, wound dehiscence, etc.), after it has been initially repaired and the patient has left the operating room.
Within 90 days post randomization
Prosthetic hip dislocation
Time Frame: Within 90 days post randomization
Any acute dislocation of a prosthetic femoral head from within its intended concentric location within the acetabulum. The acetabulum may or may not be resurfaced/replaced.
Within 90 days post randomization
Implant failure
Time Frame: Within 90 days post randomization
Any mechanical issue related to the integrity of any component of the hip implant which requires a surgical procedure to correct. This includes: loss of implant fixation to bone (either with or without associated periprosthetic fracture); or broken, disassociated, or dislocated implant components.
Within 90 days post randomization
Peri-prosthetic fracture
Time Frame: Within 90 days post randomization
Fracture through any part of either the femur and/or acetabulum to which a hip implant used for hip repair/reconstruction was fixed.
Within 90 days post randomization
Acute kidney injury
Time Frame: Within 90 days post randomization
An increase in the serum creatinine concentration from the pre-randomization value of ≥26.5 μmol/L (≥0.3 mg/dL) within 48 hours after randomization, or an increase of ≥50% within 7 days after randomization.
Within 90 days post randomization
Hospital re-admission
Time Frame: Within 90 days post randomization
Hospital re-admission following discharge from index hospitalization
Within 90 days post randomization
Length of critical care stay
Time Frame: Within 90 days post randomization
Length of critical care stay
Within 90 days post randomization
Length of rehabilitation stay
Time Frame: Within 90 days post randomization
Length of rehabilitation stay
Within 90 days post randomization
Days alive at home
Time Frame: Within 90 days post randomization
Days alive at home are the number of days patients spend at their usual residence without, during that day, being admitted to a hospital or visiting an emergency department or urgent-care centre. Patients lose days alive at home if 1. patients go to an emergency department or urgent-care centre; 2. they become inpatients at a hospital or rehabilitation or convalescence-care facility; or 3. they die.
Within 90 days post randomization
New clinically important atrial fibrillation or flutter
Time Frame: Within 90 days post randomization
Documentation of atrial fibrillation or atrial flutter of any duration on an ECG, telemetry tracing, or rhythm strip and results in angina, congestive heart failure, symptomatic hypotension, or is followed by initiation or a dose increase of a rate controlling drug, antiarrhythmic drug, or electrical cardioversion.
Within 90 days post randomization
Sepsis
Time Frame: Within 90 days post randomization

Based on the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) criteria,20 sepsis will require a quick Sequential Organ Failure Assessment (qSOFA) Score ≥2 points or patients requiring vasopressors/inotropes due to infection. The qSOFA includes the following items and scoring system:

  1. Altered mental status (1 point),
  2. Systolic blood pressure (SBP)of 100 mm Hg or less (1 point), and
  3. Respiratory rate (RR) of 22 breaths/min or more (1 point).
Within 90 days post randomization
Acute renal failure resulting in dialysis
Time Frame: Within 90 days post randomization
New requirement for dialysis (i.e., use of hemodialysis machine or peritoneal dialysis apparatus in patients without a requirement for dialysis prior to randomization).
Within 90 days post randomization

Collaborators and Investigators

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

Sponsor

Population Health Research Institute

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Flavia Borges, M.D, Population Health Research Institute
  • Principal Investigator: Robert Feibel, M.D, The Ottawa Hospital
  • Study Chair: PJ Devereaux, M.D, Population Health Research Institute
  • Principal Investigator: Gerard Slobogean, M.D, University of Maryland, Baltimore

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)

November 22, 2021

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

February 3, 2021

First Submitted That Met QC Criteria

February 3, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 25, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • v2.0_20230608

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The Population Health Research Institute (PHRI) is the sponsor of this trial. The PHRI believes the dissemination of clinical research results is vital and sharing of data is important. PHRI prioritizes access to data analyses to researchers who have worked on the trial for a significant duration, have played substantial roles, and have participated in raising the funds to conduct the trial. PHRI balances the length of the research study, and the intellectual and financial investments that made it possible with the need to allow wider access to the data collected. Data will be disclosed only upon request and approval of the proposed use of the data by a Review Committee.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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