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Coronary Artery DiseasePhase 4WARRIORNCT03417388

Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD

A Phase 4 study testing High dose potent statin, ACE-I (lisinopril) or ARB (losartan) and Aspirin 81 enteric coated tablet daily in people with Coronary Artery Disease, run by Cedars-Sinai Medical Center at 81 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The Ischemia-IMT (Ischemia-Intensive Medical Treatment Reduces Events in Women with Non-Obstructive CAD), subtitle: Women's Ischemia Trial to Reduce Events in Non-Obstructive CAD (WARRIOR) trial is a multicenter, prospective, randomized, blinded outcome evaluation (PROBE design) evaluating intensive statin/ACE-I (or… Read more about this study

Who is it for?
Ages 18 to 100 years, women only
Conditions the study is for
Coronary Artery Disease
What is being tested?
High dose potent statin, ACE-I (lisinopril) or ARB (losartan) and Aspirin 81 enteric coated tablet daily
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,476 participants
Where
81 sitesin 2 countries
Study dates
9 Feb 2018to 16 Apr 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 to 100 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signs and symptoms of suspected ischemia prompting referral for further evaluation by cardiac catheterization or coronary angiogram or coronary CT angiogram within 5 years from consent
  • Willing to provide written informed consent
  • Non-obstructive CAD defined as 0 to 49% diameter reduction of a major epicardial vessel or a FFR>0.80

Who cannot join

  • History of noncompliance (with medical therapy, protocol, or follow-up)
  • History of non-ischemic dilated or hypertrophic cardiomyopathy
  • Documented acute coronary syndrome(ACS) within previous 30 days
  • Left ventricular ejection fraction (LVEF) <40%, New York Heart Association heart failure (NYHA HF) class III-IV, or hospitalization for Reduced ejection fraction (HFrEF) within 180 days
  • Stroke within previous 180 days or intracranial hemorrhage at any time
  • End-stage renal disease, on dialysis, or estimated glomerular filtration rate (eGFR) <30 ml/min.
Show all 12Show fewer
  • Severe valvular disease or likely to require surgery/Transcatheter aortic valve replacement (TVAR) within 3 years
  • Life expectancy <3-yrs. due to non-cardiovascular comorbidity
  • Enrolled in a competing clinical trial
  • Prior intolerance to both an ACE-I and ARB
  • If intolerant to a statin unless taking a PCSK9 as a statin replacement by their clinical provider
  • Pregnancy (all pre-menopausal females must have negative urine pregnancy test if randomized to IMT before study drugs are prescribed. If they have not gone through menopause, had a hysterectomy, oophorectomy, or sterilization such as tubal ligation procedure)

Trial locations and contacts

81 sites in 2 countries.

81 sites in 2 countries

United States80 sites

  • Peak Clinical Trials, LLC

    Apex, North Carolina, 27502

  • Emory University

    Atlanta, Georgia, 30322

  • Seton Heart Institute

    Austin, Texas, 78705

  • Austin Heart

    Austin, Texas, 78756

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

  • Western Kentucky Heart And Lung

    Bowling Green, Kentucky, 42103

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Loyola University Chicago

    Chicago, Illinois, 60660

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Trihealth Heart Institute

    Cincinnati, Ohio, 45242

  • Clearwater Cardiovascular Consultants Clinical Research

    Clearwater, Florida, 33756

  • Bassett Healthcare Network

    Cooperstown, New York, 13326

  • South Palm Cardiovascular Research Institute

    Delray Beach, Florida, 33446

  • Essentia Institute of Rural Health

    Duluth, Minnesota, 55805

  • Midwest Cardiovascular Research and Education Foundation

    Elkhart, Indiana, 46514

  • Medicoricium

    Fairview Heights, Illinois, 62208

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Lutheran Health Physicians

    Fort Wayne, Indiana, 46804

  • Family Medicine at Eastside Community Practice

    Gainesville, Florida, 32206

  • Family Medicine at Hampton Oaks Medical Plaza (Adults and Peds)

    Gainesville, Florida, 32607

  • Internal Medicine at Tower Hill

    Gainesville, Florida, 32607

  • Family Medicine at Haile Plantation (Adults & Peds)

    Gainesville, Florida, 32608

  • Malcom Randall VA Medical Center

    Gainesville, Florida, 32608

  • Cardiovascular Clinic at UF Health UF

    Gainesville, Florida, 32610

  • Internal Medicine at UF Health Medical Plaza

    Gainesville, Florida, 32610

  • Spring Hill Cardiology

    Gainesville, Florida, 32610

  • Family Medicine at 4th Ave

    Gainesville, Florida, 32611

  • Family Medicine at Old Town (Adults and Peds)

    Gainesville, Florida, 32680

  • Dignity Health-Mercy Gilbert Medical Center

    Gilbert, Arizona, 85297

  • Silver State Cardiology

    Henderson, Nevada, 89052

  • Baptist Health

    Jacksonville, Florida, 32207

  • University of Florida, Jacksonville

    Jacksonville, Florida, 32209

  • Naval Hospital Jacksonville

    Jacksonville, Florida, 32214

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

  • UF Primary Care at Lake City SW

    Lake City, Florida, 32024

  • UF Primary Care at Lake City West

    Lake City, Florida, 32024

  • The Research Group of Lexington, LLC

    Lexington, Kentucky, 40503

  • University of Kentucky

    Lexington, Kentucky, 40506

  • University of Arkansas

    Little Rock, Arkansas, 72205

  • Cedars-Sinai Heart Institute

    Los Angeles, California, 90048

  • UCLA Medical Center

    Los Angeles, California, 90095

  • Charles H. Croft MDPA

    Melbourne, Florida, 32901

  • Mid Michigan Health

    Midland, Michigan, 48670

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • Cardiology Associates of Mobile, Inc.

    Mobile, Alabama, 36608

  • West Virginia University

    Morgantown, West Virginia, 26508

  • Daytona Heart Group

    Multiple Locations, Florida, 32114

  • Southwest Florida Research Institute

    Naples, Florida, 34102

  • NYU Langone

    New York, New York, 10016

  • Weil Medical college of Cornell

    New York, New York, 10065

  • Cardiovascular Instititute of Central Florida

    Ocala, Florida, 34471

  • Ocala Research Institute Inc.

    Ocala, Florida, 34480

  • CHI Health Research Center

    Omaha, Nebraska, 68124

  • Orlando Health

    Orlando, Florida, 32806

  • Midwest Heart and Vascular Specialists

    Overland Park, Kansas, 66211

  • Naval Hospital Pensacola

    Pensacola, Florida, 32512

  • Dignity Health-St. Joseph

    Phoenix, Arizona, 85013

  • Pinehurst Medical Clinic

    Pinehurst, North Carolina, 38274

  • Berkshire Medical Center

    Pittsfield, Massachusetts, 01201

  • Chippenham Hospital

    Richmond, Virginia, 23225

  • Jamaica Hospital Medical Center

    Richmond Hill, New York, 11418

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • Carilion Clinic

    Roanoke, Virginia, 24017

  • San Antonio Endovascular and Heart Institute

    San Antonio, Texas, 78258

  • Cardiovascular Center of Sarasota

    Sarasota, Florida, 34239

  • Advent Sebring

    Sebring, Florida, 33872

  • Heart House Research Foundation

    Springfield, Ohio, 45505

  • James A. Haley Veterans Hospital

    Tampa, Florida, 33612

  • AdventHealth Tampa - Pepin Heart Institute

    Tampa, Florida, 33613

  • Interventional Cardiac Consultants

    Tampa, Florida, 33613

  • BayCare Medical Group

    Tampa, Florida, 33614

  • Baylor Scott and White

    Temple, Texas, 76508

  • Cardiovascular Consultants of South Georgia, LLC.

    Thomasville, Georgia, 31792

  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

    Torrance, California, 90502

  • University of Arizona

    Tucson, Arizona, 85721

  • Cardiology Associates Research, LLC

    Tupelo, Mississippi, 38801

  • Cardiology Associates Research. LLC

    Tupelo, Mississippi, 38801

  • Carle Foundation Hospital

    Urbana, Illinois, 61801

  • Georgetown University

    Washington D.C., District of Columbia, 20057

  • Guardian Research

    Winter Park, Florida, 32792

Other trials in United States

Puerto Rico1 site

  • VA Caribbean Healthcare System

    San Juan, San Juan, 00921

Other trials in Puerto Rico

About this study

The Ischemia-IMT (Ischemia-Intensive Medical Treatment Reduces Events in Women with Non-Obstructive CAD), subtitle: Women's Ischemia Trial to Reduce Events in Non-Obstructive CAD (WARRIOR) trial is a multicenter, prospective, randomized, blinded outcome evaluation (PROBE design) evaluating intensive statin/ACE-I (or ARB)/aspirin treatment (IMT) vs. usual care (UC) in 4,422 symptomatic women patients with symptoms and/or signs of ischemia but no obstructive CAD. The hypothesis is that IMT will reduce major adverse coronary events (MACE) 20% vs. UC. The primary outcome is first occurrence of MACE as death, nonfatal MI, nonfatal stroke/transient ischemic attack (TIA) or hospitalization for heart failure or angina. Secondary outcomes include quality of life, time to "return to duty"/work, health resource consumption, angina, cardiovascular (CV) death and primary outcome components. Events will be adjudicated by an experienced Clinical Events Committee (CEC). Follow-up was planned to be 3-years using 50 sites: primarily VA and Active Duty Military Hospitals/Clinics and a National Patient-Centered Clinical Research Network (PCORnet) clinical data research network (CDRN)(OneFlorida Consortium). The number of sites were increased and follow up was modified to continue until the last patient enrolled was followed until trial follow up was completed. Recruitment was complete January 6, 2024.

This study is being conducted to determine whether intensive medication treatment to modify risk factors and vascular function in women patients with coronary arteries showing no flow limit obstruction but with cardiac symptoms (i.e., chest pain, shortness of breath) will reduce the patient's likelihood of dying, having a heart attack, stroke/TIA or being hospitalized for cardiac reasons. The results will provide evidence data necessary to inform future guidelines regarding how best to treat this growing population of patients, and ultimately improve the patient's cardiac health and quality of life and reduce health-care costs.

Read the detailed description

WARRIOR trial is a multi-site, PROBE design, that will evaluate an intensive statin/ACE-I (or ARB)/aspirin treatment strategy (IMT) vs. primary prevention risk factor therapy treatment strategy (UC) in 4,422 symptomatic (chronic angina or equivalent) women with non-obstructive CAD (<50% diameter narrowing).

There will be ~80 US sites, including VA/ military and OneFlorida CDRN sites, with a proven record in prior trials. The investigators will use web-based, real-time data entry, and management University of Florida Data Management System (UFDMS) for site selection, screening, participant eligibility confirmation, enrollment, and randomization. Participants will be recruited from screened women with symptoms suspected to be ischemic with non-obstructive CAD by invasive coronary angiogram or CT angiogram. The high dose statin (atorvastatin or rosuvastatin) and ACE-I (lisinopril) [or ARB (losartan)] are generic commonly used medications previously demonstrated effective for improving angina, stress testing, myocardial perfusion and coronary microvascular flow reserve in small size trials in this population. Additionally, aspirin will also be recommended to IMT participants without contraindications or excess bleeding risk, however aspirin will not be provided by the study. Both the groups will also receive Lifestyle Counseling (PACE Assessment), and the same visit schedule and "face-time" with site staff to reduce bias. Events will be adjudicated by the Clinical Events Committee (CEC), according to objective criteria and masked to treatment assignment clues.

Being tested
High dose potent statin, ACE-I (lisinopril) or ARB (losartan), Aspirin 81 enteric coated tablet daily, Lifestyle Counseling, Quality of Life Questionnaires
Keywords
Coronary Angiography, Coronary CT Angiogram, Ischemia, Non-obstructive CAD
Medical subject headings
Coronary Artery Disease, Ischemia

What participants receive

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

  • High dose potent statinDrug

    Also called atorvastatin or rosuvastatin

    The IMT-assigned women will receive high-dose, potent statin (atorvastatin 40-80 mg/d or rosuvastatin 20-40mg) class of lipid-lowering medications.

  • ACE-I (lisinopril) or ARB (losartan)Drug

    Also called ACE-I or ARB

    Angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) are widely prescribed for primary hypertension.

  • Aspirin 81 enteric coated tablet dailyDrug

    Also called Aspirin

    Will be recommended to IMT women without contraindications or bleeding risk.

  • Lifestyle CounselingBehavioural

    Also called PACE Lifestyle Intervention

    The PACE Lifestyle Assessment Intervention which is a program to assist with smoking cessation, weight loss, and exercise.

  • Quality of Life QuestionnairesBehavioural

    Also called QOL

    Quality of Life Questionnaires will be obtained.

Study groups in NCT03417388
Study groupRoleWhat they receive
Intensive Medical Treatment (IMT)ExperimentalThe IMT-assigned women will receive high dose potent statin, and moderate dose of an ACE-I (lisinopril) or ARB (losartan). Aspirin will also be recommended to IMT women without contraindications or bleeding risk. This group will also receive Lifestyle Counseling (PACE Assessment), Quality of Life questionnaires, and the same visit schedule and "face-time" with site staff to reduce bias.
Receives: Drug: High dose potent statin; Drug: ACE-I (lisinopril) or ARB (losartan); Drug: Aspirin 81 enteric coated tablet daily; Behavioral: Lifestyle Counseling; Behavioral: Quality of Life Questionnaires
Usual Care (UC)Active comparatorThe UC-assigned women will maintain standard of care. This group will also receive Lifestyle Counseling (PACE Assessment), Quality of Life questionnaires, and the same visit schedule and "face-time" with site staff to reduce bias.
Receives: Behavioral: Quality of Life Questionnaires

What is being measured

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

  1. The primary outcome is MACE, defined as first occurrence of all-cause death, non-fatal MI, non-fatal stroke, or hospitalization for angina or HF.

    All-cause death will be used 1) CV death is insensitive in this population with non-obstructive CAD since death is less likely attributed to CV causes when no obstructive CAD is present; 2) all-cause death is resistant to ascertainment bias in this unblinded trial. CV death will be defined broadly to include both definite CV death and possible CV death (all deaths except those with definite non-CV cause, e.g., cancer, witnessed trauma and homicide).

    The MI definition follows universal criteria for Types 1-5 MI events. Stroke/TIA definition is new onset neurological defect of central origin confirmed by brain imaging (CT or MRI) evidence of cerebral infarction or intracerebral hemorrhage.

    Hospitalization for angina- Any hospitalization for angina, plus unstable angina or ACS.

    Hospitalization for Heart Failure -required established objective criteria for heart failure.

    All MACE events are adjudicated by a blinded Clinical Endpoint Committee

    Measured: Within 5 years

Secondary outcomes (12)

  1. Components of MACE

    The analysis will be repeated for the following combinations of MACE events (1) composite outcome of CV-death, non-fatal MI, or non-fatal stroke/TIA; (2) composite outcome CV-death, non-fatal MI, resuscitated cardiac arrest, or hospitalization for angina or heart failure; (3) all-cause mortality; (4) CV-death (5) total MI [fatal plus non-fatal]; (6) resuscitated cardiac arrest; (7) hospitalization for angina; (8) hospitalization for HF; (9) total stroke/TIA [fatal plus non- fatal]; (10) composite outcome of CV-death, non-fatal MI, stroke/TIA, resuscitated cardiac arrest, or hospitalization for angina or heart failure.

    Measured: Within 5 years

  2. Composite hierarchical MACE endpoint

    The comparison of randomized treatment strategies for composite hierarchical endpoint will be conducted using win statistics (WS), including the win ratio (WR), win odds (WO), will be computed to compare two groups based on hierarchical order of clinical importance as follows: 1) all cause death within 5 yrs, 2) stroke within 5 yrs, 3) MI within 5 yrs, 4) number of hospitalization within 5 yrs, 5) first hospitalization for heart failure or chest pain within 5 yrs, and 6) average of SAQ7 at 6 months and 1-year. The WR method compares each patient in the intervention group with every patient in the control group, and the magnitude of the effect is computed as the ratio of the total number of pairwise "wins" to "losses" considering the predefined hierarchy of the outcomes. Since the WR does not account for ties that the WO will also be computed. The benefit of the IMT arm is indicated by an estimate of WS/WO test statistic with their respective 95% confidence intervals greater than 1.

    Measured: Within 5 years

  3. Seattle Angina Questionnaire (SAQ).

    QoL comparisons will adhere to the ITT principle. We will examine changes over time from baseline and identify the major determinants of those changes using regression analysis. Questionnaires, such as the SAQ scores, at each time point will be analyzed using linear mixed models with correlation within subjects over time. In case the outcome residuals do not have a normal distribution, a transformation will be considered (e.g. log, Box-Cox). Interaction of group and time effects will be examined to assess for different time trends between groups.

    Measured: Study entry and every six months until end of follow up (up to 72 months)

  4. EQ-5D-3L

    Evaluated over time by group.

    Measured: Study entry and every six months until end of follow up (up to 72 months)

  5. Duke Activity Status Inventory (DASI)

    DASI as assessed over time by group.

    Measured: Study entry and every six months until end of follow up (up to 72 months)

  6. Modified Morisky Medicine Scale Take your medication

    Measure of medication compliance between groups over time.

    Measured: Study entry and every six months until end of follow up (up to 72 months)

  7. PACE (Programs of All-Inclusive Care for the Elderly).

    Assessment of healthy lifestyle intervention between groups over time.

    Measured: Study entry and every six months until end of follow up (up to 72 months)

  8. PCL-5 (Screening for PTSD).

    Screening for PTSD over time between groups

    Measured: Study entry and every six months until end of follow up (up to 72 months)

  9. Health care utilization and cost effectiveness

    Comparing health care resource utilization across time between groups.

    Measured: Study entry and every six months until end of follow up (up to 72 months)

  10. GAD 7

    Assessment of general anxiety over time between groups

    Measured: Study entry and every six months until end of follow up (up to 72 months)

  11. PHQ 8

    Assessment of depression over time between groups

    Measured: Study entry and every six months until end of follow up (up to 72 months)

  12. MACE and Quality of Life outcomes will also be stratified by enrollment assessment of non-obstructive CAD using noninvasive CCTA vs invasive coronary angiography

    MACE is first occurrence of all cause death, non fatal MI, non fatal stroke or TIA, hospitalization for heart failure, hospitalization for chest pain/angina. Quality of life is being assessed using Seattle Angina Questionnaire, SAQ7 and all of the SAQ domains, PTSD is being assessed using the PCL5, functional capacity is being assessed using the Duke Activity Status Index, EQ-5D-3L, Depression is being assessed using the PHQ-8 and anxiety using the GAD-7

    Measured: Within 5 years

Timeline

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

  1. First posted31 Jan 2018
  2. Study start9 Feb 2018
  3. Primary completion31 May 2024
  4. Study completion16 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This will be a PROBE design, that will evaluate an intensive statin/ACE-I (or ARB) plus ASA if tolerated, treatment strategy (IMT) vs. primary prevention risk factor therapy treatment strategy (UC) in symptomatic (chronic angina or equivalent) women with non-obstructive CAD.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,476 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03417388
Sponsor's protocol ID
IRB201701142 -A
Other IDs
W81XWH-17-2-0030, OCR17268, IRB201802734, IRB201701434
Acronym
WARRIOR
Status last verified
Oct 2026
First submitted
24 Jan 2018
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pepine CJ, Handberg E, Cooper-DeHoff R, Cook-Wiens G, Diniz MA, Frayne S, Lo MC, Smith SM, Harris B, Wei J, Chaitman BR, Spertus JA, Berry C, Weintraub W, Bairey Merz CN. Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD (WARRIOR): a randomised controlled trial. Open Heart. 2026 Apr 3;13(1):e004115. doi: 10.1136/openhrt-2026-004115.

    PubMed 41932694

  • Lakshmanan S, Wei J, Cook-Wiens G, Pepine CJ, Handberg EM, Shaw LJ, Budoff M, Merz CNB. Comparison of risk profiles of participants in the Women's IschemiA TRial to Reduce events In non-ObstRuctive CAD (WARRIOR) trial, using Coronary Computed Tomography Angiography vs Invasive Coronary Angiography. Prog Cardiovasc Dis. 2024 May-Jun;84:90-93. doi: 10.1016/j.pcad.2024.03.008. Epub 2024 Mar 26.

    PubMed 38547955

  • Ya'Qoub L, Elgendy IY, Pepine CJ. Non-obstructive Plaque and Treatment of INOCA: More to Be Learned. Curr Atheroscler Rep. 2022 Sep;24(9):681-687. doi: 10.1007/s11883-022-01044-4. Epub 2022 Jul 4.

    PubMed 35781776

  • Handberg EM, Merz CNB, Cooper-Dehoff RM, Wei J, Conlon M, Lo MC, Boden W, Frayne SM, Villines T, Spertus JA, Weintraub W, O'Malley P, Chaitman B, Shaw LJ, Budoff M, Rogatko A, Pepine CJ. Rationale and design of the Women's Ischemia Trial to Reduce Events in Nonobstructive CAD (WARRIOR) trial. Am Heart J. 2021 Jul;237:90-103. doi: 10.1016/j.ahj.2021.03.011. Epub 2021 Mar 18.

    PubMed 33745898

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing High dose potent statin, ACE-I (lisinopril) or ARB (losartan) and Aspirin 81 enteric coated tablet daily in people with Coronary Artery Disease, run by Cedars-Sinai Medical Center at 81 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 3 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

The primary outcome is MACE, defined as first occurrence of all-cause death, non-fatal MI, non-fatal stroke, or hospitalization for angina or HF. (time frame: Within 5 years). 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 NCT03417388, which also lists 4 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 30 Oct 2026.

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