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

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
High dose potent statin
ACE-I (lisinopril) or ARB (losartan)
Aspirin
Lifestyle Counseling
Quality of Life Questionnaires
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Angiography, Coronary CT Angiogram, Ischemia, Non-obstructive CAD

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Cardiology Associates of Mobile, Inc.Recruiting
  • Dignity Health-Mercy Gilbert Medical CenterRecruiting
  • Dignity Health-St. JosephRecruiting
  • University of ArizonaRecruiting
  • University of ArkansasRecruiting
  • Cedars-Sinai Heart InstituteRecruiting
  • UCLA Medical CenterRecruiting
  • Loma Linda University Health
  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical CenterRecruiting
  • Georgetown UniversityRecruiting
  • Clearwater Cardiovascular Consultants Clinical ResearchRecruiting
  • South Palm Cardiovascular Research InstituteRecruiting
  • Family Medicine at Eastside Community PracticeRecruiting
  • Family Medicine at Hampton Oaks Medical Plaza (Adults and Peds)Recruiting
  • Internal Medicine at Tower HillRecruiting
  • Family Medicine at Haile Plantation (Adults & Peds)Recruiting
  • Malcom Randall VA Medical CenterRecruiting
  • Cardiovascular Clinic at UF Health UFRecruiting
  • Internal Medicine at UF Health Medical PlazaRecruiting
  • Spring Hill CardiologyRecruiting
  • Family Medicine at 4th AveRecruiting
  • Family Medicine at Old Town (Adults and Peds)Recruiting
  • Baptist HealthRecruiting
  • University of Florida, JacksonvilleRecruiting
  • Naval Hospital JacksonvilleRecruiting
  • Mayo Clinic JacksonvilleRecruiting
  • UF Primary Care at Lake City SWRecruiting
  • UF Primary Care at Lake City WestRecruiting
  • Charles H. Croft MDPARecruiting
  • Daytona Heart GroupRecruiting
  • Southwest Florida Research InstituteRecruiting
  • Cardiovascular Instititute of Central FloridaRecruiting
  • Ocala Research Institute Inc.Recruiting
  • Orlando HealthRecruiting
  • Naval Hospital PensacolaRecruiting
  • Cardiovascular Center of SarasotaRecruiting
  • Advent SebringRecruiting
  • James A. Haley Veterans HospitalRecruiting
  • AdventHealth Tampa - Pepin Heart InstituteRecruiting
  • Interventional Cardiac ConsultantsRecruiting
  • BayCare Medical GroupRecruiting
  • Guardian ResearchRecruiting
  • Emory UniversityRecruiting
  • Cardiovascular Consultants of South Georgia, LLC.Recruiting
  • Loyola University ChicagoRecruiting
  • MedicoriciumRecruiting
  • Carle Foundation HospitalRecruiting
  • Midwest Cardiovascular Research and Education FoundationRecruiting
  • Lutheran Health PhysiciansRecruiting
  • Midwest Heart and Vascular SpecialistsRecruiting
  • Western Kentucky Heart And LungRecruiting
  • The Research Group of Lexington, LLCRecruiting
  • University of Kentucky
  • Tulane University Heart and Vascular Institute
  • Walter Reed National Military Medical CenterRecruiting
  • Berkshire Medical CenterRecruiting
  • Mid Michigan HealthRecruiting
  • Essentia Institute of Rural HealthRecruiting
  • Minneapolis Heart Institute FoundationRecruiting
  • Cardiology Associates Research, LLCRecruiting
  • Cardiology Associates Research. LLCRecruiting
  • CHI Health Research CenterRecruiting
  • Silver State CardiologyRecruiting
  • The Valley HospitalRecruiting
  • Bassett Healthcare NetworkRecruiting
  • NYU LangoneRecruiting
  • Weil Medical college of CornellRecruiting
  • Jamaica Hospital Medical Center
  • Peak Clinical Trials, LLCRecruiting
  • Pinehurst Medical ClinicRecruiting
  • The Christ HospitalRecruiting
  • Trihealth Heart InstituteRecruiting
  • Heart House Research FoundationRecruiting
  • Seton Heart InstituteRecruiting
  • Austin HeartRecruiting
  • Brooke Army Medical CenterRecruiting
  • San Antonio Endovascular and Heart InstituteRecruiting
  • Baylor Scott and WhiteRecruiting
  • University of Virginia Health SystemRecruiting
  • Chippenham HospitalRecruiting
  • Carilion ClinicRecruiting
  • West Virginia UniversityRecruiting
  • VA Caribbean Healthcare SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensive Medical Treatment (IMT)

Usual Care (UC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

All Cause Death incidents reported between the two groups
Collection of all deaths reported between the two groups will use the log rank test for comparison of outcomes. Although the power analysis required the exponential assumption, the actual statistical test is free of assumptions, as the null hypothesis is that the survival distributions for the two strategies are the same, and therefore the null hazard ratio is 1.00 (proportional hazards).
Non-fatal myocardial infarction (MI) incidents reported between the two groups
Collection of all non-fatal MI's reported between the two groups will use the log rank test for comparison of outcomes. Although the power analysis required the exponential assumption, the actual statistical test is free of assumptions, as the null hypothesis is that the survival distributions for the two strategies are the same, and therefore the null hazard ratio is 1.00 (proportional hazards). MI definition follows universal criteria for Types 1-5 MI events. Specifically, the use of the "Third Universal Definition of Myocardial Infarction" detection of a rise and/or fall of cardiac biomarker values, with at least one value >99th percentile upper reference limit and preferred biomarker is Cardiac troponin (cTn).
Stroke/TIA incidents reported between the two groups
Collection of all strokes or transient ischemic attack (TIA) reported between the two groups will use the log rank test for comparison of outcomes. Although the power analysis required the exponential assumption, the actual statistical test is free of assumptions, as the null hypothesis is that the survival distributions for the two strategies are the same, and therefore the null hazard ratio is 1.00 (proportional hazards). The stroke definition is new onset neurological defect of central origin confirmed by brain imaging (CT or MRI) evidence of cerebral infarction or intracerebral hemorrhage. The definition of TIA is the same as stroke except no confirmation by brain imaging, but confirmed by a neurologist consult.
Hospitalizations for cardiovascular events reported between the two groups
Collection of all hospitalization for cardiovascular events reported between the two groups will use the log rank test for comparison of outcomes. Although the power analysis required the exponential assumption, the actual statistical test is free of assumptions, as the null hypothesis is that the survival distributions for the two strategies are the same, and therefore the null hazard ratio is 1.00 (proportional hazards). Cardiovascular causes includes accelerated angina, persistent angina, unstable angina.
Hospitalizations for heart failure incidents reported between the two groups
Collection of all hospitalizations for heart failure between the two groups will use the log rank test for comparison of outcomes. Although the power analysis required the exponential assumption, the actual statistical test is free of assumptions, as the null hypothesis is that the survival distributions for the two strategies are the same, and therefore the null hazard ratio is 1.00 (proportional hazards).

Secondary Outcome Measures

Full Information

First Posted
January 24, 2018
Last Updated
February 9, 2023
Sponsor
University of Florida
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT03417388
Brief Title
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Acronym
WARRIOR
Official Title
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2018 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Angiography, Coronary CT Angiogram, Ischemia, Non-obstructive CAD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
The Clinical Events Committee (CEC) will be masked to all treatment assignment.
Allocation
Randomized
Enrollment
4422 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intensive Medical Treatment (IMT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care (UC)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
High dose potent statin
Other Intervention Name(s)
atorvastatin or rosuvastatin
Intervention Description
The IMT-assigned women will receive high-dose, potent statin (atorvastatin 40-80 mg/d or rosuvastatin 20-40mg) class of lipid-lowering medications.
Intervention Type
Drug
Intervention Name(s)
ACE-I (lisinopril) or ARB (losartan)
Other Intervention Name(s)
ACE-I or ARB
Intervention Description
Angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) are widely prescribed for primary hypertension.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Will be recommended to IMT women without contraindications or bleeding risk.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Counseling
Other Intervention Name(s)
PACE Lifestyle Intervention
Intervention Description
The PACE Lifestyle Assessment Intervention which is a program to assist with smoking cessation, weight loss, and exercise.
Intervention Type
Behavioral
Intervention Name(s)
Quality of Life Questionnaires
Other Intervention Name(s)
QOL
Intervention Description
Quality of Life Questionnaires will be obtained.
Primary Outcome Measure Information:
Title
All Cause Death incidents reported between the two groups
Description
Collection of all deaths reported between the two groups will use the log rank test for comparison of outcomes. Although the power analysis required the exponential assumption, the actual statistical test is free of assumptions, as the null hypothesis is that the survival distributions for the two strategies are the same, and therefore the null hazard ratio is 1.00 (proportional hazards).
Time Frame
3 years
Title
Non-fatal myocardial infarction (MI) incidents reported between the two groups
Description
Collection of all non-fatal MI's reported between the two groups will use the log rank test for comparison of outcomes. Although the power analysis required the exponential assumption, the actual statistical test is free of assumptions, as the null hypothesis is that the survival distributions for the two strategies are the same, and therefore the null hazard ratio is 1.00 (proportional hazards). MI definition follows universal criteria for Types 1-5 MI events. Specifically, the use of the "Third Universal Definition of Myocardial Infarction" detection of a rise and/or fall of cardiac biomarker values, with at least one value >99th percentile upper reference limit and preferred biomarker is Cardiac troponin (cTn).
Time Frame
3 years
Title
Stroke/TIA incidents reported between the two groups
Description
Collection of all strokes or transient ischemic attack (TIA) reported between the two groups will use the log rank test for comparison of outcomes. Although the power analysis required the exponential assumption, the actual statistical test is free of assumptions, as the null hypothesis is that the survival distributions for the two strategies are the same, and therefore the null hazard ratio is 1.00 (proportional hazards). The stroke definition is new onset neurological defect of central origin confirmed by brain imaging (CT or MRI) evidence of cerebral infarction or intracerebral hemorrhage. The definition of TIA is the same as stroke except no confirmation by brain imaging, but confirmed by a neurologist consult.
Time Frame
3 years
Title
Hospitalizations for cardiovascular events reported between the two groups
Description
Collection of all hospitalization for cardiovascular events reported between the two groups will use the log rank test for comparison of outcomes. Although the power analysis required the exponential assumption, the actual statistical test is free of assumptions, as the null hypothesis is that the survival distributions for the two strategies are the same, and therefore the null hazard ratio is 1.00 (proportional hazards). Cardiovascular causes includes accelerated angina, persistent angina, unstable angina.
Time Frame
3 years
Title
Hospitalizations for heart failure incidents reported between the two groups
Description
Collection of all hospitalizations for heart failure between the two groups will use the log rank test for comparison of outcomes. Although the power analysis required the exponential assumption, the actual statistical test is free of assumptions, as the null hypothesis is that the survival distributions for the two strategies are the same, and therefore the null hazard ratio is 1.00 (proportional hazards).
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dana D Leach, ARNP-BC
Phone
352-273-8933
Email
dana.leach@medicine.ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Debra Landers
Phone
352-273-7901
Email
debra.landers@medicine.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl J Pepine, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology Associates of Mobile, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth Wagner
Phone
251-340-6870
First Name & Middle Initial & Last Name & Degree
Jason Cole, MD
Facility Name
Dignity Health-Mercy Gilbert Medical Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
480-728-9971
First Name & Middle Initial & Last Name & Degree
Rachel Bond
Facility Name
Dignity Health-St. Joseph
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
602-406-1156
First Name & Middle Initial & Last Name & Degree
Pallavi Bellamkonda
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
520-626-5431
First Name & Middle Initial & Last Name & Degree
Nancy Sweitzer
Facility Name
University of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cindy Witkowski, RN, BSN
Phone
501-214-2438
Ext
46009
Email
witkowskicynthial@uams.edu
First Name & Middle Initial & Last Name & Degree
Srikanth Vallurupalli, MD
Facility Name
Cedars-Sinai Heart Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Aguilar-Hernandez
Phone
310-423-9666
Email
Leslie.Aguilar-Hernandez@cshs.org
First Name & Middle Initial & Last Name & Degree
Martha Gulati, MD
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
310-825-9011
First Name & Middle Initial & Last Name & Degree
Karol Watson
Facility Name
Loma Linda University Health
City
Redlands
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Withdrawn
Facility Name
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
310-222-4107
First Name & Middle Initial & Last Name & Degree
Matthew Budoff, MD
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
202-444-6619
First Name & Middle Initial & Last Name & Degree
Barbara Srichai-Parsia
Facility Name
Clearwater Cardiovascular Consultants Clinical Research
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
727-467-9393
Ext
3139
First Name & Middle Initial & Last Name & Degree
A-Hamid Hakki, MD
Facility Name
South Palm Cardiovascular Research Institute
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33446
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
561-203-6690
First Name & Middle Initial & Last Name & Degree
Gustavo Cardenas, MD
Facility Name
Family Medicine at Eastside Community Practice
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States
Individual Site Status
Recruiting
Facility Name
Family Medicine at Hampton Oaks Medical Plaza (Adults and Peds)
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Individual Site Status
Recruiting
Facility Name
Internal Medicine at Tower Hill
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
352-273-8933
First Name & Middle Initial & Last Name & Degree
Neil Holland
First Name & Middle Initial & Last Name & Degree
Ashleigh Wright
Facility Name
Family Medicine at Haile Plantation (Adults & Peds)
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Name
Malcom Randall VA Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Stinson, BSN
Phone
352-339-2759
First Name & Middle Initial & Last Name & Degree
Carsten Schmalfuss, MD
Facility Name
Cardiovascular Clinic at UF Health UF
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
352-273-8933
First Name & Middle Initial & Last Name & Degree
David Anderson, MD
Facility Name
Internal Medicine at UF Health Medical Plaza
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
352-273-8933
First Name & Middle Initial & Last Name & Degree
Margaret Lo
First Name & Middle Initial & Last Name & Degree
Dianne Goede
Facility Name
Spring Hill Cardiology
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
352-273-8933
First Name & Middle Initial & Last Name & Degree
Ki Park, MD
Facility Name
Family Medicine at 4th Ave
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Recruiting
Facility Name
Family Medicine at Old Town (Adults and Peds)
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32680
Country
United States
Individual Site Status
Recruiting
Facility Name
Baptist Health
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
904-339-0037
First Name & Middle Initial & Last Name & Degree
Ruple Galani, MD
Facility Name
University of Florida, Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
904-244-3095
First Name & Middle Initial & Last Name & Degree
Gladys Velarde
Facility Name
Naval Hospital Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
352-273-8933
First Name & Middle Initial & Last Name & Degree
David Volk, MD
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prachi Kulahalli
Phone
904-953-4832
Email
kulahalli.prachi@mayo.edu
First Name & Middle Initial & Last Name & Degree
Amy Pollak, MD
Facility Name
UF Primary Care at Lake City SW
City
Lake City
State/Province
Florida
ZIP/Postal Code
32024
Country
United States
Individual Site Status
Recruiting
Facility Name
UF Primary Care at Lake City West
City
Lake City
State/Province
Florida
ZIP/Postal Code
32024
Country
United States
Individual Site Status
Recruiting
Facility Name
Charles H. Croft MDPA
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline Talbott
Phone
321-432-7497
Email
studyprospect@gmail.com
First Name & Middle Initial & Last Name & Degree
Charles H Croft
Facility Name
Daytona Heart Group
City
Multiple Locations
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Glenn Rayos, MD
Phone
386-258-8722
Facility Name
Southwest Florida Research Institute
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mike Halbert, Pharm.D.
Phone
239-213-0213
Ext
201
First Name & Middle Initial & Last Name & Degree
Ariel De La Rosa, MD
Facility Name
Cardiovascular Instititute of Central Florida
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
352-662-4251
Ext
357
First Name & Middle Initial & Last Name & Degree
Hima Mikkilineli, MD
Facility Name
Ocala Research Institute Inc.
City
Ocala
State/Province
Florida
ZIP/Postal Code
34480
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
352-622-7008
Ext
245
First Name & Middle Initial & Last Name & Degree
Rakesh Prashad, MD
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
321-841-1505
First Name & Middle Initial & Last Name & Degree
Arnold Einhorn, MD
Facility Name
Naval Hospital Pensacola
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32512
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
352-273-8933
First Name & Middle Initial & Last Name & Degree
Carrie Gray, MD
Facility Name
Cardiovascular Center of Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
941-366-9800
First Name & Middle Initial & Last Name & Degree
Mahfouz Shahawy, MD
Facility Name
Advent Sebring
City
Sebring
State/Province
Florida
ZIP/Postal Code
33872
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Leicht
Phone
863-402-5304
Email
james.leicht@adventhealth.com
First Name & Middle Initial & Last Name & Degree
Deepti Bhandare, MD
Facility Name
James A. Haley Veterans Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
813-972-2000
Ext
7618
First Name & Middle Initial & Last Name & Degree
Fabio Leonelli
Facility Name
AdventHealth Tampa - Pepin Heart Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
813-615-7200
Ext
52294
First Name & Middle Initial & Last Name & Degree
Charles R Lambert, MD
Facility Name
Interventional Cardiac Consultants
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
727-842-9486
First Name & Middle Initial & Last Name & Degree
Carlos J Bayron, MD
Facility Name
BayCare Medical Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pam Paul
Phone
727-723-6511
First Name & Middle Initial & Last Name & Degree
Lang Lin
Facility Name
Guardian Research
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Gilliam
Phone
386-785-2400
Ext
327
Email
jgilliam@accelclinical.com
First Name & Middle Initial & Last Name & Degree
Ashish Gupta, MD
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
404-778-2746
First Name & Middle Initial & Last Name & Degree
Ijeoma Isiadinso
Facility Name
Cardiovascular Consultants of South Georgia, LLC.
City
Thomasville
State/Province
Georgia
ZIP/Postal Code
31792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shelli Roberts
Phone
229-672-1780
Email
smroberts@ccsgheart.com
First Name & Middle Initial & Last Name & Degree
Clay Sizemore, MD
Facility Name
Loyola University Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60660
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
708-216-2646
First Name & Middle Initial & Last Name & Degree
Caroline Ball
Facility Name
Medicoricium
City
Fairview Heights
State/Province
Illinois
ZIP/Postal Code
62208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
618-222-8900
Ext
108
First Name & Middle Initial & Last Name & Degree
Omar Almousalli
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
217-904-7187
First Name & Middle Initial & Last Name & Degree
Ahmad Shihabi
Facility Name
Midwest Cardiovascular Research and Education Foundation
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vijay Mehta, MD
Phone
574-522-0337
First Name & Middle Initial & Last Name & Degree
Vijay Mehta, MD
Facility Name
Lutheran Health Physicians
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
260-432-2297
First Name & Middle Initial & Last Name & Degree
Esosa Odigie-Okon
Facility Name
Midwest Heart and Vascular Specialists
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Fulks
Phone
913-253-3022
Email
Elizabeth.Fulks@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Stephen Bloom, MD
Facility Name
Western Kentucky Heart And Lung
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
270-782-0151
First Name & Middle Initial & Last Name & Degree
Jacqueline Dawson Dowe, MD
Facility Name
The Research Group of Lexington, LLC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacy Newsome, CCRP
Phone
859-977-4005
Email
stacy@researchgrouplexington.com
First Name & Middle Initial & Last Name & Degree
Neil Ferris, MD
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Tulane University Heart and Vascular Institute
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Withdrawn
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Weber, MD
Phone
301-295-6814
Email
lauren.a.weber3.mil@mail.mil
First Name & Middle Initial & Last Name & Degree
Lauren Weber, MD
Facility Name
Berkshire Medical Center
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
413-395-7910
First Name & Middle Initial & Last Name & Degree
Georgianne Valli-Harwood, MD
Facility Name
Mid Michigan Health
City
Midland
State/Province
Michigan
ZIP/Postal Code
48670
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
989-631-2469
First Name & Middle Initial & Last Name & Degree
Oluwafemi Showole
Facility Name
Essentia Institute of Rural Health
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaitlyn Rikkola
Phone
218-786-8364
Email
Kaitlyn.Rikkola@EssentiaHealth.org
First Name & Middle Initial & Last Name & Degree
Catherine Benziger, MD
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Retu Saxena, MD
Phone
612-863-3900
First Name & Middle Initial & Last Name & Degree
Retu Saxena, MD
Facility Name
Cardiology Associates Research, LLC
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Watts
Phone
662-620-6863
Email
twatts5933@nmhs.net
First Name & Middle Initial & Last Name & Degree
William Calhoun, MD
Facility Name
Cardiology Associates Research. LLC
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
662-620-6863
First Name & Middle Initial & Last Name & Degree
William Calhoun
Facility Name
CHI Health Research Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mel Romsa
Phone
402-343-8511
First Name & Middle Initial & Last Name & Degree
Arun Kanmantha-Reddy, MD
Facility Name
Silver State Cardiology
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
702-683-7876
First Name & Middle Initial & Last Name & Degree
Leonard Parilak, MD
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
201-447-8453
First Name & Middle Initial & Last Name & Degree
Himanshu Gupta
Facility Name
Bassett Healthcare Network
City
Cooperstown
State/Province
New York
ZIP/Postal Code
13326
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dhananjai Menzies
Phone
607-547-3383
First Name & Middle Initial & Last Name & Degree
Dhananjai Menzies
Facility Name
NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
211-263-0474
First Name & Middle Initial & Last Name & Degree
Nathaniel Smilowitz
Facility Name
Weil Medical college of Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
646-962-5555
First Name & Middle Initial & Last Name & Degree
Nivee Amin
Facility Name
Jamaica Hospital Medical Center
City
Richmond Hill
State/Province
New York
ZIP/Postal Code
11418
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Peak Clinical Trials, LLC
City
Apex
State/Province
North Carolina
ZIP/Postal Code
27502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara White
Phone
919-267-5209
First Name & Middle Initial & Last Name & Degree
Mehar Ambati, MD
Facility Name
Pinehurst Medical Clinic
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
38274
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Meyer
Phone
910-235-3144
Email
rmeyer@pinehurstmedical.com
First Name & Middle Initial & Last Name & Degree
Joseph Hakas, MD
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
513-585-1924
First Name & Middle Initial & Last Name & Degree
Odayme Quesada
Facility Name
Trihealth Heart Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
513-862-2877
First Name & Middle Initial & Last Name & Degree
Kamal Shemisa
Facility Name
Heart House Research Foundation
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
937-523-9545
First Name & Middle Initial & Last Name & Degree
Sayed T Rizvi, MD
Facility Name
Seton Heart Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Benedict
Phone
512-324-3434
First Name & Middle Initial & Last Name & Degree
Caitlin Giesler, MD
Facility Name
Austin Heart
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
512-396-5603
First Name & Middle Initial & Last Name & Degree
Juhana Karha, MD
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
210-916-7796
First Name & Middle Initial & Last Name & Degree
Emilio Fentanes
Facility Name
San Antonio Endovascular and Heart Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Kunik
Phone
210-912-8180
Email
pkunik@drkiesz.com
First Name & Middle Initial & Last Name & Degree
Radoslaw Stefan Kiesz, MD
Facility Name
Baylor Scott and White
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanda Fikes
Phone
254-724-5373
First Name & Middle Initial & Last Name & Degree
Robert Widmer, MD
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Taylor
Phone
434-982-1058
First Name & Middle Initial & Last Name & Degree
Angela Taylor
Facility Name
Chippenham Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Burton
Phone
804-560-8880
Email
Stephanie.Burton@HCAhealthcare.com
First Name & Middle Initial & Last Name & Degree
Michael Arcarese, MD
Facility Name
Carilion Clinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
540-982-8204
First Name & Middle Initial & Last Name & Degree
Jacek Slowikowski
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Morgan
Phone
304-598-6092
First Name & Middle Initial & Last Name & Degree
Irfan Zeb, MD
Facility Name
VA Caribbean Healthcare System
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiomarie Ojeda-Rodriguez
Phone
787-641-7582
Ext
31785
First Name & Middle Initial & Last Name & Degree
Sonia Vicenty, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35781776
Citation
Ya'Qoub L, Elgendy IY, Pepine CJ. Non-obstructive Plaque and Treatment of INOCA: More to Be Learned. Curr Atheroscler Rep. 2022 Sep;24(9):681-687. doi: 10.1007/s11883-022-01044-4. Epub 2022 Jul 4.
Results Reference
derived
PubMed Identifier
33745898
Citation
Handberg EM, Merz CNB, Cooper-Dehoff RM, Wei J, Conlon M, Lo MC, Boden W, Frayne SM, Villines T, Spertus JA, Weintraub W, O'Malley P, Chaitman B, Shaw LJ, Budoff M, Rogatko A, Pepine CJ. Rationale and design of the Women's Ischemia Trial to Reduce Events in Nonobstructive CAD (WARRIOR) trial. Am Heart J. 2021 Jul;237:90-103. doi: 10.1016/j.ahj.2021.03.011. Epub 2021 Mar 18.
Results Reference
derived

Learn more about this trial

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

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