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Can a Triple-Drug combo save Women's hearts when arteries look clear?

NCT ID NCT03417388

Disease control Sponsor: Cedars-Sinai Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a combination of high-dose statins, blood pressure medications (ACE inhibitors or ARBs), and low-dose aspirin can reduce the risk of death, heart attack, stroke, or hospitalization in women who have chest pain or shortness of breath but no major blockages in their heart arteries. About 2,500 women are participating across multiple sites, and they are randomly assigned to either the intensive medication regimen or usual care. The goal is to see if this approach lowers major heart events by at least 20% over three years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
High-dose statin (atorvastatin or rosuvastatin), ACE inhibitor (lisinopril) or ARB (losartan), and low-dose aspirin
What this could lead to
If successful, this could establish a standard medication regimen to prevent heart attacks, strokes, and hospitalizations in women with chest pain but no blocked arteries.
What could go wrong
This is a phase 4 trial, so the drugs are already approved, but the specific combination may not reduce heart events as hoped. Side effects from statins or blood pressure meds are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

2,476 people

The number who actually took part.

Started

Feb 2018

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

coronary artery disorder ischemic disease nonobstructive coronary artery disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease

Contacts and locations

Locations

  • Advent Sebring

    Sebring, Florida, 33872, United States

  • AdventHealth Tampa - Pepin Heart Institute

    Tampa, Florida, 33613, United States

  • Austin Heart

    Austin, Texas, 78756, United States

  • Baptist Health

    Jacksonville, Florida, 32207, United States

  • Bassett Healthcare Network

    Cooperstown, New York, 13326, United States

  • BayCare Medical Group

    Tampa, Florida, 33614, United States

  • Baylor Scott and White

    Temple, Texas, 76508, United States

  • Berkshire Medical Center

    Pittsfield, Massachusetts, 01201, United States

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234, United States

  • CHI Health Research Center

    Omaha, Nebraska, 68124, United States

  • Cardiology Associates Research, LLC

    Tupelo, Mississippi, 38801, United States

  • Cardiology Associates Research. LLC

    Tupelo, Mississippi, 38801, United States

  • Cardiology Associates of Mobile, Inc.

    Mobile, Alabama, 36608, United States

  • Cardiovascular Center of Sarasota

    Sarasota, Florida, 34239, United States

  • Cardiovascular Clinic at UF Health UF

    Gainesville, Florida, 32610, United States

  • Cardiovascular Consultants of South Georgia, LLC.

    Thomasville, Georgia, 31792, United States

  • Cardiovascular Instititute of Central Florida

    Ocala, Florida, 34471, United States

  • Carilion Clinic

    Roanoke, Virginia, 24017, United States

  • Carle Foundation Hospital

    Urbana, Illinois, 61801, United States

  • Cedars-Sinai Heart Institute

    Los Angeles, California, 90048, United States

  • Charles H. Croft MDPA

    Melbourne, Florida, 32901, United States

  • Chippenham Hospital

    Richmond, Virginia, 23225, United States

  • Clearwater Cardiovascular Consultants Clinical Research

    Clearwater, Florida, 33756, United States

  • Daytona Heart Group

    Multiple Locations, Florida, 32114, United States

  • Dignity Health-Mercy Gilbert Medical Center

    Gilbert, Arizona, 85297, United States

  • Dignity Health-St. Joseph

    Phoenix, Arizona, 85013, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Essentia Institute of Rural Health

    Duluth, Minnesota, 55805, United States

  • Family Medicine at 4th Ave

    Gainesville, Florida, 32611, United States

  • Family Medicine at Eastside Community Practice

    Gainesville, Florida, 32206, United States

  • Family Medicine at Haile Plantation (Adults & Peds)

    Gainesville, Florida, 32608, United States

  • Family Medicine at Hampton Oaks Medical Plaza (Adults and Peds)

    Gainesville, Florida, 32607, United States

  • Family Medicine at Old Town (Adults and Peds)

    Gainesville, Florida, 32680, United States

  • Georgetown University

    Washington D.C., District of Columbia, 20057, United States

  • Guardian Research

    Winter Park, Florida, 32792, United States

  • Heart House Research Foundation

    Springfield, Ohio, 45505, United States

  • Internal Medicine at Tower Hill

    Gainesville, Florida, 32607, United States

  • Internal Medicine at UF Health Medical Plaza

    Gainesville, Florida, 32610, United States

  • Interventional Cardiac Consultants

    Tampa, Florida, 33613, United States

  • Jamaica Hospital Medical Center

    Richmond Hill, New York, 11418, United States

  • James A. Haley Veterans Hospital

    Tampa, Florida, 33612, United States

  • Loyola University Chicago

    Chicago, Illinois, 60660, United States

  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

    Torrance, California, 90502, United States

  • Lutheran Health Physicians

    Fort Wayne, Indiana, 46804, United States

  • Malcom Randall VA Medical Center

    Gainesville, Florida, 32608, United States

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224, United States

  • Medicoricium

    Fairview Heights, Illinois, 62208, United States

  • Mid Michigan Health

    Midland, Michigan, 48670, United States

  • Midwest Cardiovascular Research and Education Foundation

    Elkhart, Indiana, 46514, United States

  • Midwest Heart and Vascular Specialists

    Overland Park, Kansas, 66211, United States

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407, United States

  • NYU Langone

    New York, New York, 10016, United States

  • Naval Hospital Jacksonville

    Jacksonville, Florida, 32214, United States

  • Naval Hospital Pensacola

    Pensacola, Florida, 32512, United States

  • Ocala Research Institute Inc.

    Ocala, Florida, 34480, United States

  • Orlando Health

    Orlando, Florida, 32806, United States

  • Peak Clinical Trials, LLC

    Apex, North Carolina, 27502, United States

  • Pinehurst Medical Clinic

    Pinehurst, North Carolina, 38274, United States

  • San Antonio Endovascular and Heart Institute

    San Antonio, Texas, 78258, United States

  • Seton Heart Institute

    Austin, Texas, 78705, United States

  • Silver State Cardiology

    Henderson, Nevada, 89052, United States

  • South Palm Cardiovascular Research Institute

    Delray Beach, Florida, 33446, United States

  • Southwest Florida Research Institute

    Naples, Florida, 34102, United States

  • Spring Hill Cardiology

    Gainesville, Florida, 32610, United States

  • The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • The Research Group of Lexington, LLC

    Lexington, Kentucky, 40503, United States

  • The Valley Hospital

    Ridgewood, New Jersey, 07450, United States

  • Trihealth Heart Institute

    Cincinnati, Ohio, 45242, United States

  • UCLA Medical Center

    Los Angeles, California, 90095, United States

  • UF Primary Care at Lake City SW

    Lake City, Florida, 32024, United States

  • UF Primary Care at Lake City West

    Lake City, Florida, 32024, United States

  • University of Arizona

    Tucson, Arizona, 85721, United States

  • University of Arkansas

    Little Rock, Arkansas, 72205, United States

  • University of Florida, Jacksonville

    Jacksonville, Florida, 32209, United States

  • University of Kentucky

    Lexington, Kentucky, 40506, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

  • VA Caribbean Healthcare System

    San Juan, San Juan, 00921, Puerto Rico

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889, United States

  • Weil Medical college of Cornell

    New York, New York, 10065, United States

  • West Virginia University

    Morgantown, West Virginia, 26508, United States

  • Western Kentucky Heart And Lung

    Bowling Green, Kentucky, 42103, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.