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

About

Brief 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 4

Eligibility

Gender

Female

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

100 Years

Inclusion Criteria:

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

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 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.
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)