Intensive Cardiovascular Medication for Coronary Artery Disease

(WARRIOR Trial)

Recruiting at 84 trial locations

Overseen By Nancy Sweitzer

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Florida

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Carl J Pepine, MD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for women with symptoms of ischemia (like chest pain) and non-obstructive coronary artery disease, which means their heart arteries are not severely narrowed. They should have had a cardiac evaluation within the last 5 years and be willing to consent to the study. Women who are pregnant or have serious heart conditions, severe kidney disease, or a recent stroke aren't eligible.

Inclusion Criteria

Willing to provide written informed consent

You have experienced symptoms that suggest a potential heart problem and have been referred for heart tests within the last 5 years.

You do not have significant blockages in your heart arteries.

Exclusion Criteria

You had a heart attack in the last 30 days.

History of noncompliance (with medical therapy, protocol, or follow-up)

You have a history of a certain heart condition called dilated or hypertrophic cardiomyopathy that is not caused by reduced blood flow to the heart.

Treatment Details

Interventions

• ACE-I (lisinopril) or ARB (losartan) (ACE Inhibitor/ARB)
• Aspirin (Drug)
• High dose potent statin (Statin)
• Lifestyle Counseling (Behavioral)
• Quality of Life Questionnaires (Behavioral)

Trial Overview The WARRIOR trial tests whether intensive medical treatment with statins, ACE inhibitors (or ARBs), and aspirin can reduce major adverse coronary events in women compared to usual care. It's a randomized study where outcomes like heart attacks and quality of life will be tracked over three years.

Participant Groups

Group I: Intensive Medical Treatment (IMT) Experimental Treatment 5 Interventions

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 II: Usual Care (UC) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+