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

Study acronym: WARRIOR
StatusActive, Not Recruiting
PhasePhase 4
Started2018-02-09
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 29, 2026 (before its estimated September 14, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-05-27
Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations v46
Sponsor changed: University of Florida → Cedars-Sinai Medical Center+6 characters
WasUniversity of Florida
NowCedars-Sinai Medical Center
Study sitesdetails revised at 1 of 81 sites
Collaborators1 to 2 entries
University of Florida
2026-02-18
Completed→Active, Not Recruiting Study Status v45
Trial statusCompleted→Active, Not Recruiting
Primary completion date2025-01-03→2026-09-14
Completion date2025-09-14→2026-09-14
2025-10-14
Active, Not Recruiting→Completed Study Status v44
Trial statusActive, Not Recruiting→Completed
2025-08-04
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Document Section v43
Primary completion dateestimated 2025-02-28→confirmed 2025-01-03
Completion date2025-09-30→2025-09-14
InterventionsACE-I (lisinopril) or ARB (losartan) (Drug), Aspirin (Drug), High dose potent statin (Drug), Lifestyle Counseling (Behavioral), Quality of…→ACE-I (lisinopril) or ARB (losartan) (Drug), Aspirin 81 enteric coated tablet daily (Drug), High dose potent statin (Drug), Lifestyle…
Secondary endpoints+495 characters
Components of MACE Composite hierarchical MACE endpoint Seattle Angina Questionnaire (SAQ). EQ-5D-3L Duke Activity Status Inventory (DASI) Modified Morisky Medicine Scale Take your medication PACE (Programs of All-Inclusive Care for the Elderly). PCL-5 (Screening for PTSD). Health care utilization a [...]
Primary endpoints5 to 1 entries
AllThe Causeprimary Deathoutcome incidentsis reportedMACE, betweendefined theas twofirst groups Hospitalizationsoccurrence of all-cause death, non-fatal MI, non-fatal stroke, or hospitalization for cardiovascularangina eventsor reported between the two groups Hospitalizations for heart failure incidents reported between the two groups Non-fatal myocardial infarction (MI) incidents reported between the two groups Stroke/TIA incidents reported between the two groupsHF.
2025-02-03
Study Status v42
Primary completion date2024-09-30→2025-02-28
Completion date2024-12-30→2025-09-30
Show 41 earlier versions
2024-04-18
Study Status v41
Re-verified, no change to tracked fields
2024-04-10
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v40
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2023-09-30→2024-09-30
Completion date2023-12-30→2024-12-30
Enrollment targetestimated 4422→confirmed 2476
Study sites83→81
2023-02-09
Study Status, Contacts/Locations v39
Study sites84→83
2021-09-14
Study Status, Contacts/Locations v38
Study sites68→84
2021-08-11
Study Identification, Study Status, Study Description v37
Primary completion date2021-12-30→2023-09-30
Completion date2022-12-30→2023-12-30
Study descriptionrevised
[...] n-obstructive CAD (<50% diameter narrowing). There will be ~5080 US sites, including VA/ military and OneFlorida CDRN sites, [...]
2021-01-26
Study Status, Contacts/Locations v36
Study sites66→68
2020-09-03
Study Status, Contacts/Locations v35
Study sites53→66
2020-05-27
Study Status, Eligibility, Contacts/Locations v34
Study sites49→53
Eligibility criteria+3 characters
[...] giogram or coronary CT angiogram within 5 years from consent. Willing to provide written informed consent. Non-obstructive CAD defined as <500 to 49% diameter reduction of a major epicardial vessel or a FFR>0.80 Exclusion Criteria: 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 He [...] zation for Reduced ejection fraction (HFrEF) within 180 days. Stroke within previous 180 days. or intracra [...] [...]
2020-02-13
Study Status, Contacts/Locations v33
Study sites46→49
2020-01-28
Study Status, Contacts/Locations v32
Study sites45→46
2020-01-25
Study Status, Contacts/Locations v31
Study sitesdetails revised at 2 of 45 sites
2020-01-14
Study Status, Contacts/Locations v30
Study sites44→45
2020-01-04
Study Status, Contacts/Locations v29
Study sites41→44
2020-01-02
Study Status, Contacts/Locations v28
Study sites30→41
2019-08-16
Study Status, Eligibility, Contacts/Locations v27
Study sites29→30
Eligibility criteria-73 characters
[...] ented acute coronary syndrome(ACS) within previous 30 days. Patients who have a Class 1 indication for high intensity statin therapy Left ventricular ejection fraction (LVEF) <40%, New York Hea [...]
2019-06-06
Study Identification, Study Status, Contacts/Locations v26
Study sites28→29
2019-05-16
Study Status v25
Re-verified, no change to tracked fields
2019-05-10
Study Status, Eligibility v24
Eligibility criteriarevised
[...] ation or coronary angiogram or coronary CT angiogram within 35 years from consent. Willing to provide written informed con [...]
2019-04-19
Study Status, Contacts/Locations v23
Study sites27→28
2019-03-21
Study Status, Eligibility, Contacts/Locations v22
Study sites25→27
Eligibility criteriarevised
[...] ation or coronary angiogram or coronary CT angiogram within 53 years from consent. Willing to provide written informed con [...]
2019-03-11
Study Identification, Study Status v21
Re-verified, no change to tracked fields
2019-03-05
Study Status, Eligibility v20
Eligibility criteria+312 characters
[...] r further evaluation by cardiac catheterization or coronary angiogram or coronary CT angiogram within 5 years from consent. Willing to provide written informed consent. Non-obstructi [...] ined as <50% diameter reduction of a major epicardial vessel by invasive angiography or coronary computed tomography angiography within previous 5 years. Exclusion Criteria: History of noncompliance (with medical [...] ented acute coronary syndrome(ACS) within previous 30 days. Patients who have a Class 1 indication for high intensity statin therapy Left ventricular ejection fraction (LVEF) <40%, New York Hea [...] clinical tria [...]
2019-01-17
Study Status, Contacts/Locations v19
Study sites25 entries, revised
Florida HospitalAdventHealth Tampa - Pepin Heart Institute
2019-01-11
Study Identification, Study Status v18
Re-verified, no change to tracked fields
2019-01-09
Study Status, Contacts/Locations v17
Study sites24→25
2018-12-03
Study Status, Study Design, Contacts/Locations v16
Enrollment target550→4422
Study sites23→24
2018-11-20
Study Status, Eligibility v15
Eligibility criteria+13 characters
[...] iography or coronary computed tomography angiography within 2previous yrs5 years. Exclusion Criteria: History of noncompliance (with medical [...] gery/Transcatheter aortic valve replacement (TVAR) within 5 yrsyears. Life expectancy <3-yrs. due to non-cardiovascular comorbid [...]
2018-11-14
Study Status, Contacts/Locations v14
Study sites21→23
2018-11-13
Study Status, Contacts/Locations v13
Study sites20→21
2018-11-06
Study Status, Study Description, Arms and Interventions, Contacts/Locations v12
Study sites21→20
InterventionsACE-I (lisinopril) or ARB (losartan) (Drug), Aspirin (Drug), High dose potent statin (Drug), Lifestyle Counseling (Behavioral), PCSK9…→ACE-I (lisinopril) or ARB (losartan) (Drug), Aspirin (Drug), High dose potent statin (Drug), Lifestyle Counseling (Behavioral), Quality of…
Study description-124 characters
[...] erve in small size trials in this population. Additionally, if IMT-assigned participants are statin intolerant or if LDL<100 is not achieved, a PCSK9 Inhibitor will be made available. Aspirinaspirin will also be recommended to IMT participants without contra [...]
2018-11-01
Study Status, Contacts/Locations v11
Study sites20→21
2018-10-02
Study Status v10
Re-verified, no change to tracked fields
2018-09-19
Study Status, Contacts/Locations v9
Study sites17→20
2018-08-31
Study Status, Contacts/Locations v8
Study sites15→17
2018-08-14
Study Status, Contacts/Locations v7
Study sites12→15
2018-06-21
2 amendments v5-v6
2 re-verifications since 2018-06-13, no change to tracked fields
2018-05-17
Study Identification, Study Status, Study Design, Arms and Interventions, Contacts/Locations v4
Enrollment target4422→550
InterventionsACE-I (lisinopril) or ARB (losartan) (Drug), Aspirin (Drug), Evolocumab (Drug), High dose potent statin (Drug), Lifestyle Counseling…→ACE-I (lisinopril) or ARB (losartan) (Drug), Aspirin (Drug), High dose potent statin (Drug), Lifestyle Counseling (Behavioral), PCSK9…
2018-05-03
Study Status, Contacts/Locations v3
Study sites11→12
2018-02-12
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2018-02-02→confirmed 2018-02-09
Study description+1 characters
[...] orida CDRN sites, with a proven record in prior trials. The invesigatorsinvestigators will use web-based, real-time data entry, and management Un [...]
Study sitesdetails revised at 11 of 11 sites
Study title-23 characters
Ischemia-IntensiveWomen's MedicalIschemiA TreatmentTRial Reducesto Reduce Events in Women WithIn Non-obstructiveObstRuctive CAD
2018-01-31
Study Status, Study Description, Arms and Interventions v1
Study description+36 characters
[...] neFlorida CDRN sites, with a proven record in prior trials. WeThe invesigators will use web-based, real-time data entry, and management Un [...] ta Management System (UFDMS) for site selection, screening, patientparticipant eligibility confirmation, enrollment, and randomization. PatientsParticipants will be recruited from screened women with symptoms suspect [...] ze trials in this population. Additionally, if IMT-assigned womenparticipants are statin intolerant or if LDL<100 is not achieved, a PCSK [...] be made available. Aspirin will also be recommended to IMT womenparticipants without contraindications or ex [...]
2018-01-24
Original filing
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.
Trial Details
NCT Number NCT03417388
Lead Sponsor Cedars-Sinai Medical Center
Collaborators: United States Department of Defense, University of Florida
Conditions Coronary Artery Disease
Enrollment 2,476 participants
Start Date 2018-02-09
Primary Completion 2026-09-14 (estimated)
Study Completion 2026-09-14 (estimated)
Updated on ClinicalTrials.gov 2026-05-29