Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD (NCT03417388)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Cardiology Associates of Mobile, Inc. — Mobile, Alabama
Age range: 18 Years to 100 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (81 Sites)
Showing the first 25 of 81 sites.
- Cardiology Associates of Mobile, Inc. — Mobile, Alabama
- Dignity Health-Mercy Gilbert Medical Center — Gilbert, Arizona
- Dignity Health-St. Joseph — Phoenix, Arizona
- University of Arizona — Tucson, Arizona
- University of Arkansas — Little Rock, Arkansas
- Cedars-Sinai Heart Institute — Los Angeles, California
- UCLA Medical Center — Los Angeles, California
- Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center — Torrance, California
- Georgetown University — Washington D.C., District of Columbia
- Clearwater Cardiovascular Consultants Clinical Research — Clearwater, Florida
- South Palm Cardiovascular Research Institute — Delray Beach, Florida
- Family Medicine at Eastside Community Practice — Gainesville, Florida
- Family Medicine at Hampton Oaks Medical Plaza (Adults and Peds) — Gainesville, Florida
- Internal Medicine at Tower Hill — Gainesville, Florida
- Family Medicine at Haile Plantation (Adults & Peds) — Gainesville, Florida
- Malcom Randall VA Medical Center — Gainesville, Florida
- Cardiovascular Clinic at UF Health UF — Gainesville, Florida
- Internal Medicine at UF Health Medical Plaza — Gainesville, Florida
- Spring Hill Cardiology — Gainesville, Florida
- Family Medicine at 4th Ave — Gainesville, Florida
- Family Medicine at Old Town (Adults and Peds) — Gainesville, Florida
- Baptist Health — Jacksonville, Florida
- University of Florida, Jacksonville — Jacksonville, Florida
- Naval Hospital Jacksonville — Jacksonville, Florida
- Mayo Clinic Jacksonville — Jacksonville, Florida
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.