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Women's IschemiA TRial to Red...

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

Last Updated: 2025-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2476 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-09

Study Completion Date

2025-09-14

Brief Summary

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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 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.

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Detailed Description

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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 \~80 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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be a PROBE design, that will evaluate an intensive statin/ACE-I (or ARB) plus ASA if tolerated, treatment strategy (IMT) vs. primary prevention risk factor therapy treatment strategy (UC) in symptomatic (chronic angina or equivalent) women with non-obstructive CAD.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The Clinical Events Committee (CEC) will be masked to all treatment assignment.

Study Groups

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Intensive Medical Treatment (IMT)

The IMT-assigned women will receive high dose potent statin, and moderate dose of an ACE-I (lisinopril) or ARB (losartan). Aspirin will also be recommended to IMT women without contraindications or bleeding risk. This group will also receive Lifestyle Counseling (PACE Assessment), Quality of Life questionnaires, and the same visit schedule and "face-time" with site staff to reduce bias.

Group Type EXPERIMENTAL

High dose potent statin

Intervention Type DRUG

The IMT-assigned women will receive high-dose, potent statin (atorvastatin 40-80 mg/d or rosuvastatin 20-40mg) class of lipid-lowering medications.

ACE-I (lisinopril) or ARB (losartan)

Intervention Type DRUG

Angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) are widely prescribed for primary hypertension.

Aspirin 81 enteric coated tablet daily

Intervention Type DRUG

Will be recommended to IMT women without contraindications or bleeding risk.

Lifestyle Counseling

Intervention Type BEHAVIORAL

The PACE Lifestyle Assessment Intervention which is a program to assist with smoking cessation, weight loss, and exercise.

Quality of Life Questionnaires

Intervention Type BEHAVIORAL

Quality of Life Questionnaires will be obtained.

Usual Care (UC)

The UC-assigned women will maintain standard of care. This group will also receive Lifestyle Counseling (PACE Assessment), Quality of Life questionnaires, and the same visit schedule and "face-time" with site staff to reduce bias.

Group Type ACTIVE_COMPARATOR

Quality of Life Questionnaires

Intervention Type BEHAVIORAL

Quality of Life Questionnaires will be obtained.

Interventions

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High dose potent statin

The IMT-assigned women will receive high-dose, potent statin (atorvastatin 40-80 mg/d or rosuvastatin 20-40mg) class of lipid-lowering medications.

Intervention Type DRUG

ACE-I (lisinopril) or ARB (losartan)

Angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) are widely prescribed for primary hypertension.

Intervention Type DRUG

Aspirin 81 enteric coated tablet daily

Will be recommended to IMT women without contraindications or bleeding risk.

Intervention Type DRUG

Lifestyle Counseling

The PACE Lifestyle Assessment Intervention which is a program to assist with smoking cessation, weight loss, and exercise.

Intervention Type BEHAVIORAL

Quality of Life Questionnaires

Quality of Life Questionnaires will be obtained.

Intervention Type BEHAVIORAL

Other Intervention Names

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atorvastatin or rosuvastatin ACE-I or ARB Aspirin PACE Lifestyle Intervention QOL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carl J Pepine, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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Cardiology Associates of Mobile, Inc.

Mobile, Alabama, United States

Site Status

Dignity Health-Mercy Gilbert Medical Center

Gilbert, Arizona, United States

Site Status

Dignity Health-St. Joseph

Phoenix, Arizona, United States

Site Status

University of Arizona

Tucson, Arizona, United States

Site Status

University of Arkansas

Little Rock, Arkansas, United States

Site Status

Cedars-Sinai Heart Institute

Los Angeles, California, United States

Site Status

UCLA Medical Center

Los Angeles, California, United States

Site Status

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

Torrance, California, United States

Site Status

Georgetown University

Washington D.C., District of Columbia, United States

Site Status

Clearwater Cardiovascular Consultants Clinical Research

Clearwater, Florida, United States

Site Status