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



Status:Recruiting
Conditions:Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 100
Updated:3/27/2019
Start Date:February 9, 2018
End Date:December 30, 2022
Contact:Dana D Leach, ARNP-BC
Email:dana.leach@medicine.ufl.edu
Phone:352-273-8933

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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.

WARRIOR trial is a multi-site, PROBE design, that will evaluate an intensive statin/ACE-I (or
ARB)/aspirin treatment strategy (IMT) vs. primary prevention risk factor therapy treatment
strategy (UC) in 4,422 symptomatic (chronic angina or equivalent) women with non-obstructive
CAD (<50% diameter narrowing).

There will be ~50 US sites, including VA/ military and OneFlorida CDRN sites, with a proven
record in prior trials. The investigators will use web-based, real-time data entry, and
management University of Florida Data Management System (UFDMS) for site selection,
screening, participant eligibility confirmation, enrollment, and randomization. Participants
will be recruited from screened women with symptoms suspected to be ischemic with
non-obstructive CAD by invasive coronary angiogram or CT angiogram. The high dose statin
(atorvastatin or rosuvastatin) and ACE-I (lisinopril) [or ARB (losartan)] are generic
commonly used medications previously demonstrated effective for improving angina, stress
testing, myocardial perfusion and coronary microvascular flow reserve in small size trials in
this population. Additionally, aspirin will also be recommended to IMT participants without
contraindications or excess bleeding risk, however aspirin will not be provided by the study.
Both the groups will also receive Lifestyle Counseling (PACE Assessment), and the same visit
schedule and "face-time" with site staff to reduce bias. Events will be adjudicated by the
Clinical Events Committee (CEC), according to objective criteria and masked to treatment
assignment clues.

Inclusion Criteria:

- Signs and symptoms of suspected ischemia prompting referral for further evaluation by
cardiac catheterization or coronary angiogram or coronary CT angiogram within 3 years
from consent.

- Willing to provide written informed consent.

- Non-obstructive CAD defined as <50% diameter reduction of a major epicardial vessel.

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.

- Patients who have a Class 1 indication for high intensity statin therapy

- 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 5 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 serum 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).
We found this trial at
27
sites
221 Southwest Stonegate Terrace
Lake City, Florida 32024
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24 Sturtevant St
Orlando, Florida 32806
Principal Investigator: Arnold Einhorn, MD
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Orlando, FL
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Clearwater, Florida 33756
Principal Investigator: A-Hamid Hakki, MD
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Clearwater, FL
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Delray Beach, Florida 33446
Principal Investigator: Gustavo Cardenas, MD
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Delray Beach, FL
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410 Northeast Waldo Road
Gainesville, Florida 32206
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Gainesville, FL
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200 Southwest 62nd Boulevard
Gainesville, Florida 32607
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Gainesville, FL
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7540 West University Avenue
Gainesville, Florida 32607
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Gainesville, FL
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2846 Southwest 87 Way
Gainesville, Florida 32608
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Gainesville, FL
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2000 Southwest Archer Road
Gainesville, Florida 32610
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Gainesville, FL
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2000 Southwest Archer Road
Gainesville, Florida 32610
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Gainesville, FL
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2033 Mowry Road
Gainesville, Florida 32610
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Gainesville, FL
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7120 Northwest 11th Place
Gainesville, Florida 32611
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Gainesville, FL
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625 Southwest 4th Avenue
Gainesville, Florida 32611
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Gainesville, FL
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25827 U.S. 19
Gainesville, Florida 32680
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Gainesville, FL
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Henderson, Nevada 89052
Principal Investigator: Leonard Parilak, MD
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Henderson, NV
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Jacksonville, Florida 32214
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Jacksonville, FL
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Jacksonville, Florida
Principal Investigator: Ruple Galani, MD
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Jacksonville, FL
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Lake City, Florida 32024
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Lake City, FL
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Lexington, Kentucky
859) 257-9000
Principal Investigator: Gretchen Wells, MD
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Los Angeles, California 90048
Principal Investigator: Chrisandra Shufelt, MD
Phone: 310-423-3300
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Los Angeles, CA
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Miami, Florida 33186
Phone: 786-773-2737
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Miami, FL
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Multiple Locations, Florida 32114
Phone: 386-258-8722
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Multiple Locations, FL
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Ocala, Florida 34471
Phone: 352-412-5989
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Ocala, FL
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Pensacola, Florida 32508
Principal Investigator: Carrie Gray, MD
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Pensacola, FL
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Tampa, Florida 33613
Phone: 727-842-9526
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Tampa, FL
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Tampa, Florida 33613
Phone: 813-615-7527
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Tampa, FL
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1124 West Carson Street
Torrance, California 90502
Principal Investigator: Matthew Budoff, MD
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Torrance, CA
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