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Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
NCT03417388 · View on ClinicalTrials.gov ↗
Study 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 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 qual
Conditions Studied
Interventions
- BEHAVIORAL Quality of Life Questionnaires
- BEHAVIORAL Lifestyle Counseling
- DRUG High dose potent statin
- DRUG ACE-I (lisinopril) or ARB (losartan)
- DRUG Aspirin 81 enteric coated tablet daily
Study Locations (20)
Florida
- Clearwater Cardiovascular Consultants Clinical Research — Clearwater
- South Palm Cardiovascular Research Institute — Delray Beach
- Family Medicine at Eastside Community Practice — Gainesville
- Family Medicine at Hampton Oaks Medical Plaza (Adults and Peds) — Gainesville
- Internal Medicine at Tower Hill — Gainesville
- Family Medicine at Haile Plantation (Adults & Peds) — Gainesville
- Malcom Randall VA Medical Center — Gainesville
- Cardiovascular Clinic at UF Health UF — Gainesville
- Internal Medicine at UF Health Medical Plaza — Gainesville
- Spring Hill Cardiology — Gainesville
- Family Medicine at 4th Ave — Gainesville
Arizona
- Dignity Health-Mercy Gilbert Medical Center — Gilbert
- Dignity Health-St. Joseph — Phoenix
- University of Arizona — Tucson
California
- Cedars-Sinai Heart Institute — Los Angeles
- UCLA Medical Center — Los Angeles
- Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center — Torrance
Alabama
- Cardiology Associates of Mobile, Inc. — Mobile
Arkansas
- University of Arkansas — Little Rock
District of Columbia
- Georgetown University — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,476 participants |
| Start Date | 2018-02-09 |
| Est. Completion | 2026-09-14 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03417388
The ClinicalTrials.gov registry entry for NCT03417388 describes a study currently listed as active not recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,476 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,066 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 5 interventions — of which Quality of Life Questionnaires is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03417388 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03417388 about?
NCT03417388 is a clinical study titled "Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD". 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...
What is the current status of trial NCT03417388?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 2,476 participants. The study started on 2018-02-09. Estimated completion is 2026-09-14.
What conditions does trial NCT03417388 study?
This clinical trial studies the following conditions: Coronary Artery Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03417388?
The interventions under investigation include: Quality of Life Questionnaires (BEHAVIORAL), Lifestyle Counseling (BEHAVIORAL), High dose potent statin (DRUG), ACE-I (lisinopril) or ARB (losartan) (DRUG), Aspirin 81 enteric coated tablet daily (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03417388?
This trial is sponsored by University of Florida, which has 1,066 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03417388 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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