Status:
COMPLETED
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Lead Sponsor:
University of Florida
Collaborating Sponsors:
United States Department of Defense
Conditions:
Coronary Artery Disease
Eligibility:
FEMALE
18-100 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
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) i...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2025
Estimated Enrollment :
2476 Patients enrolled
Trial Details
Trial ID
NCT03417388
Start Date
February 9 2018
End Date
September 14 2025
Last Update
October 15 2025
Active Locations (81)
Enter a location and click search to find clinical trials sorted by distance.
1
Cardiology Associates of Mobile, Inc.
Mobile, Alabama, United States, 36608
2
Dignity Health-Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
3
Dignity Health-St. Joseph
Phoenix, Arizona, United States, 85013
4
University of Arizona
Tucson, Arizona, United States, 85721