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Coronary Artery DiseasePhase 3RECHARGE:WNCT06399692

REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Women

A Phase 3 study testing Coronary artery bypass grafting (CABG) and Percutaneous coronary intervention (PCI) in people with Coronary Artery Disease, run by Weill Medical College of Cornell University at 18 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a research study in women to compare the outcomes of two procedures that restore blood flow to the arteries of the heart. In one procedure the blockages are ballooned and then stented with a small wire mesh tube through a small incision in the wrist or the groin. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Coronary artery bypass grafting (CABG) and Percutaneous coronary intervention (PCI)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
18 sitesUnited States
Study dates
16 Sep 2024to 1 Jan 2039
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female sex
  • Patient is at least 18 years old.
  • Multivessel or left main CAD is present for which revascularization is intended and for which there is equipoise between CABG and PCI according to local Heart Team assessment.
  • Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires.

Who cannot join

  • ST-segment elevation MI within 3 days
  • Cardiogenic shock
  • Prior PCI within 1 year or any in-stent restenosis with diameter stenosis ≥50% or any prior cardiac surgery
  • Planned hybrid revascularization (PCI after CABG or CABG after PCI)
  • Planned single vessel revascularization (other than isolated left main disease)
  • Need for any cardiac surgical or interventional procedure other than coronary revascularization at the present time or anticipated within 3 years, with the exception that surgical or interventional left atrial appendage ligation or occlusion and/or atrial fibrillation ablation may be performed at site discretion either during or subsequent to the index revascularization procedure
Show all 11Show fewer
  • Pregnancy (women of child-bearing potential must have a negative pregnancy test within 1 week before randomization) or intent to become pregnant within 1 year after randomization
  • Unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 3 months if presentation with stable CAD or 6 months if presentation with a troponin-positive acute coronary syndrome
  • Current participation in another investigational drug or device study that has not reached its primary endpoint
  • Life-expectancy less than 3 years due to concomitant non-cardiac conditions
  • Any condition(s) are present that are likely to interfere with the study protocol procedures including medication adherence and follow-up through 10 years (e.g. mental disability, substance abuse, anticipated international relocation, etc.)

Trial locations and contacts

18 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC contact

212.746.1812

mfg9004@med.cornell.edu

Gregg Stone, MD, FACC, MSCAI contact

Gregg.Stone@mountsinai.org

18 sites in 1 country

United States18 sites, 18 recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • Ascension St. Vincent Cardiovascular Research Institute

    Carmel, Indiana, 46290

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Recruiting

  • Baylor Scott and White

    Dallas, Texas, 75246

    Recruiting

  • Duke University

    Durham, North Carolina, 27710

    Recruiting

  • Englewood Hospital

    Englewood, New Jersey, 07631

    Recruiting

  • NewYork-Presbyterian Hospital - Queens

    Flushing, New York, 11355

    Recruiting

  • Adventist Health Glendale

    Glendale, California, 91206

    Recruiting

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

    Recruiting

  • Baptist Health Louisville

    Louisville, Kentucky, 40207

    Recruiting

  • Methodist Le Bonheur Healthcare

    Memphis, Tennessee, 38104

    Recruiting

  • Ascension Saint Thomas Hospital

    Nashville, Tennessee, 37205

    Recruiting

  • Icahn School of Medicine - Mount Sinai Morningside

    New York, New York, 10025

    Recruiting

  • Icahn School of Medicine - Mount Sinai Hospital

    New York, New York, 10029

    Recruiting

  • Columbia University Irving Medical Center/NewYork-Presbyterian Hospital

    New York, New York, 10032

    Recruiting

  • Weill Cornell Medicine / NYPH

    New York, New York, 10065

    Recruiting

  • Westchester Medical Center

    Valhalla, New York, 10595

    Recruiting

Other trials in United States

About this study

This is a research study in women to compare the outcomes of two procedures that restore blood flow to the arteries of the heart. In one procedure the blockages are ballooned and then stented with a small wire mesh tube through a small incision in the wrist or the groin. The other procedure is an open-heart operation in which healthy blood vessels from inside the chest, leg, and/or forearm are used to "bypass" the blockages (like a detour). Outcomes will be measured by comparing survival and improvement in quality-of-life.

Read the detailed description

The RECHARGE: Women Trial is a multicenter, 1:1 randomized, open-label superiority trial.

Patients meeting the eligibility criteria for whom there is equipoise for revascularization with CABG and PCI, as determined by the local Heart Team, will be included. Participants will be followed for 5-10 years. Telephone follow-up will be conducted by the a central follow-up coordinating center at 30 days, 3 months, 6 months, and thereafter every 6 months through 36 months post-randomization. After 36 months, follow-up will be performed every year (48, 60, 72, 84, 96, 108, 120 months). A repeat transthoracic echocardiogram and blood draw for serum creatinine, hemoglobin and lipids should be performed at 1 year, as per standard of care, at either an out-patient facility or in a hospital.

Being tested
Coronary artery bypass grafting (CABG), Percutaneous coronary intervention (PCI)
Keywords
RECHARGE, Cardiac Surgery, coronary artery bypass grafting, percutaneous coronary intervention, Quality of Life
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary artery bypass grafting (CABG)Procedure or surgery

    Coronary artery bypass grafting (CABG), also called heart bypass surgery, is a medical procedure to improve blood flow to the heart.

  • Percutaneous coronary intervention (PCI)Procedure or surgery

    Percutaneous coronary intervention (PCI) is a non-surgical procedure used to treat the blockages in a coronary artery; it opens up narrowed or blocked sections of the artery, restoring blood flow to the heart

Study groups in NCT06399692
Study groupRoleWhat they receive
RECHARGE:Women - CABGOtherNot described
Receives: Procedure: Coronary artery bypass grafting (CABG)
RECHARGE:Women - PCIOtherNot described
Receives: Procedure: Percutaneous coronary intervention (PCI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hierarchical composite of all-cause death and time-averaged change from baseline in generic quality of life using the SF-12v2

    Generic quality of life (QOL) will be assessed by utilizing the 12-item Short Form Survey (SF-12v2). The score ranges from 1-100, with higher scores indicating a better health status. The win ratio method will be utilized

    Measured: 5 years

Secondary outcomes (1)

  1. Time averaged change from baseline in disease-specific quality of life using the SAQ-OS

    Disease-specific quality of life (QOL) will be assessed by utilizing the Seattle Angina Questionnaire overall summary (SAQ-OS) score. The score ranges from 1-100, with higher scores indicating a better health status.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2024
  2. Study start16 Sep 2024
  3. Primary completion15 Mar 2033 (estimated)
  4. Study completion1 Jan 2039 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06399692
Sponsor's protocol ID
23-11026800 - 1
Acronym
RECHARGE:W
Status last verified
Sep 2026
First submitted
30 Apr 2024
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gaudino M, Stone GW, Puskas J, Krieger K, Redfors B, Bagiella E, Gelijns A, Bhatt DL, Sandner S, Barman N, Bozinovski J, Gee P, Haider A, Hafiz AM, Jolly SS, Li D, Mack C, Madani MM, Mahmud E, Pineda AM, Masoudi FA, Mazzaferri E, Monroe R, Nicholson W, Pocock SJ, Sachdeva R, Yong C, Zwischenberger BA, Yancy C, Creber RM, Spertus J. Lessons learned from the feasibility phase of the REvascularization CHoices Among Under-Represented Groups Evaluation (RECHARGE) trial program. Am Heart J. 2026 Jun 20;301:107515. doi: 10.1016/j.ahj.2026.107515. Online ahead of print.

    PubMed 42323001

  • Nino de Rivera S, Suero-Tejeda NM, Monroe R, Tang M, Eslami S, Sallam A, Gee PO, Redfors B, Yancy CW, Gaudino MFL, Stone GW, Spertus JA, Masterson Creber RM. Patient Perspectives in Cardiovascular Research: A Qualitative Study of Barriers, Trust, and Strategies for Inclusive Clinical Trials. Circ Popul Health Outcomes. 2026 Jul;19(7):e012189. doi: 10.1161/CIRCOUTCOMES.125.012189. Epub 2026 Jun 12.

    PubMed 42283075

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Coronary artery bypass grafting (CABG) and Percutaneous coronary intervention (PCI) in people with Coronary Artery Disease, run by Weill Medical College of Cornell University at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC (212.746.1812, mfg9004@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hierarchical composite of all-cause death and time-averaged change from baseline in generic quality of life using the SF-12v2 (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06399692, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

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