Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Purpose
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.
Condition
- Coronary Artery Disease
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This will be a PROBE design, that will evaluate an intensive statin/ACE-I (or ARB) treatment strategy (IMT) vs. primary prevention risk factor therapy treatment strategy (UC) in symptomatic (chronic angina or equivalent) women with non-obstructive CAD.
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- The Clinical Events Committee (CEC) will be masked to all treatment assignment.
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental 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. |
|
Active Comparator 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. |
|
Recruiting Locations
Mobile, Alabama 36608
Ruth Wagner
251-340-6870
Gilbert, Arizona 85297
480-728-9971
Phoenix, Arizona 85013
602-406-1156
Tucson, Arizona 85721
520-626-5431
Little Rock, Arkansas 72205
Los Angeles, California 90048
Los Angeles, California 90095
310-825-9011
Torrance, California 90502
310-222-4107
Washington, District of Columbia 20057
202-444-6619
Clearwater, Florida 33756
727-467-9393
Delray Beach, Florida 33446
561-203-6690
Gainesville, Florida 32206
Gainesville, Florida 32607
Gainesville, Florida 32607
352-273-8933
Gainesville, Florida 32608
Gainesville, Florida 32608
Susan Stinson, BSN
352-339-2759
Gainesville, Florida 32610
352-273-8933
Gainesville, Florida 32610
352-273-8933
Gainesville, Florida 32610
352-273-8933
Gainesville, Florida 32611
Gainesville, Florida 32680
Jacksonville, Florida 32207
904-339-0037
Jacksonville, Florida 32209
904-244-3095
Jacksonville, Florida 32214
352-273-8933
Jacksonville, Florida 32224
Lake City, Florida 32024
Lake City, Florida 32024
Melbourne, Florida 32901
Multiple Locations, Florida 32114
Glenn Rayos, MD
386-258-8722
Naples, Florida 34102
Mike Halbert, Pharm.D.
239-213-0213
Ocala, Florida 34471
352-662-4251
Ocala, Florida 34480
352-622-7008
Orlando, Florida 32806
321-841-1505
Pensacola, Florida 32512
352-273-8933
Sarasota, Florida 34239
941-366-9800
Sebring, Florida 33872
Tampa, Florida 33612
813-972-2000
Tampa, Florida 33613
813-615-7200
Tampa, Florida 33613
727-842-9486
Tampa, Florida 33614
Pam Paul
727-723-6511
Winter Park, Florida 32792
Atlanta, Georgia 30322
404-778-2746
Thomasville, Georgia 31792
Chicago, Illinois 60660
708-216-2646
Fairview Heights, Illinois 62208
618-222-8900
Urbana, Illinois 61801
217-904-7187
Elkhart, Indiana 46514
Vijay Mehta, MD
574-522-0337
Fort Wayne, Indiana 46804
260-432-2297
Overland Park, Kansas 66211
Bowling Green, Kentucky 42103
270-782-0151
Lexington, Kentucky 40503
Bethesda, Maryland 20889
Pittsfield, Massachusetts 01201
413-395-7910
Midland, Michigan 48670
989-631-2469
Duluth, Minnesota 55805
Minneapolis, Minnesota 55407
Retu Saxena, MD
612-863-3900
Tupelo, Mississippi 38801
Tupelo, Mississippi 38801
662-620-6863
Omaha, Nebraska 68124
Mel Romsa
402-343-8511
Henderson, Nevada 89052
702-683-7876
Ridgewood, New Jersey 07450
201-447-8453
Cooperstown, New York 13326
Dhananjai Menzies
607-547-3383
New York, New York 10016
211-263-0474
New York, New York 10065
646-962-5555
Apex, North Carolina 27502
Barbara White
919-267-5209
Pinehurst, North Carolina 38274
Cincinnati, Ohio 45219
513-585-1924
Cincinnati, Ohio 45242
513-862-2877
Springfield, Ohio 45505
937-523-9545
Austin, Texas 78705
Sarah Benedict
512-324-3434
Austin, Texas 78756
512-396-5603
Fort Sam Houston, Texas 78234
210-916-7796
San Antonio, Texas 78258
Temple, Texas 76508
Wanda Fikes
254-724-5373
Charlottesville, Virginia 22908
Angela Taylor
434-982-1058
Richmond, Virginia 23225
Roanoke, Virginia 24017
540-982-8204
Morgantown, West Virginia 26508
Melissa Morgan
304-598-6092
San Juan, Puerto Rico 00921
Yiomarie Ojeda-Rodriguez
787-641-7582
More Details
- NCT ID
- NCT03417388
- Status
- Recruiting
- Sponsor
- University of Florida
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) 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.