Intensive Cardiovascular Medication for Coronary Artery Disease
(WARRIOR Trial)
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications. However, it involves intensive treatment with statins, ACE inhibitors (or ARBs), and aspirin, so you may need to adjust your current medications under the guidance of the trial doctors.
What data supports the effectiveness of aspirin in the treatment of coronary artery disease?
Is the treatment generally safe for humans?
Aspirin, also known as acetylsalicylic acid (ASA), is commonly used for cardiovascular protection but can increase the risk of internal bleeding. While it can reduce the risk of heart attacks, it may not be suitable for everyone due to this bleeding risk, especially in people with diabetes or those using it for primary prevention.678910
What makes this drug treatment for coronary artery disease unique?
This treatment combines ACE-I (lisinopril) or ARB (losartan) with aspirin and a high-dose potent statin, which is a unique combination aimed at intensively managing coronary artery disease by addressing blood pressure, reducing blood clot risk, and lowering cholesterol levels. The use of aspirin in this combination is notable for its role in reducing the risk of heart attacks and strokes, while the high-dose statin is particularly potent in lowering cholesterol, which is crucial for heart health.111121314
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intensive statin/ACE-I (or ARB)/aspirin treatment or usual care
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ACE-I (lisinopril) or ARB (losartan)
- Aspirin
- High dose potent statin
- Lifestyle Counseling
- Quality of Life Questionnaires
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
United States Department of Defense
Collaborator