Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Status:
Recruiting
Trial end date:
2023-12-30
Target enrollment:
Participant gender:
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 will 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).
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.