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

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 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.

Conditions

• Coronary Artery Disease

Interventions

DRUG

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.

DRUG

ACE-I (lisinopril) or ARB (losartan)

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

DRUG

Aspirin 81 enteric coated tablet daily

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

BEHAVIORAL

Lifestyle Counseling

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

BEHAVIORAL

Quality of Life Questionnaires

Quality of Life Questionnaires will be obtained.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• University of Florida

  lead OTHER

Principal Investigators

• Carl J Pepine, MD · University of Florida

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-09

Primary Completion

2026-09-14

Completion

2026-09-14

FDA Drug

Yes

Countries

• United States
• Puerto Rico

Study Locations