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CABG vs PCI for Coronary Artery Disease in Women (RECHARGE:W Trial)

Phase 3
Recruiting
Led By Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female sex
Patient is at least 18 years old
Must not have
Planned single vessel revascularization (other than isolated left main disease)
Planned hybrid revascularization (PCI after CABG or CABG after PCI)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial compares two procedures for restoring blood flow to the arteries of the heart in women. One procedure involves using a wire mesh tube to open blockages through a small incision in the wrist or groin

Who is the study for?
This clinical trial is for women with coronary artery disease. It's designed to compare two different heart procedures: one that uses a small tube to open blockages and another that creates a detour around the blockage using healthy blood vessels.
What is being tested?
The study tests two treatments for blocked heart arteries in women: Percutaneous coronary intervention (PCI), where blockages are opened with a stent, and Coronary artery bypass grafting (CABG), an open-heart surgery for creating bypasses around blockages.
What are the potential side effects?
Possible side effects from PCI include bleeding at the incision site, infection, or allergic reactions to materials used. CABG may involve longer recovery times and risks like wound infections or complications from anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am female.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for a procedure to open one blocked heart artery.
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I am scheduled for a combined heart bypass and stent procedure.
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I had a major heart attack within the last 3 days.
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I have experienced a severe heart condition that suddenly reduced blood flow.
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I have had a heart stent placed within the last year or bypass surgery at any time.
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I don't need any heart surgery except for coronary revascularization now or in the next 3 years.
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My doctor expects I have less than 3 years to live due to other health conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hierarchical composite of all-cause death and time-averaged change from baseline in generic quality of life using the SF-12v2
Secondary study objectives
Time averaged change from baseline in disease-specific quality of life using the SAQ-OS
Other study objectives
Change in LVEF
Time-averaged changes in EQ5D-VAS Scores
Time-averaged changes in MoCA scores
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: RECHARGE:Women - PCIExperimental Treatment1 Intervention
Group II: RECHARGE:Women - CABGExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Percutaneous coronary intervention (PCI)
2010
Completed Phase 4
~31230
Coronary artery bypass grafting (CABG)
1997
N/A
~560

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,087 Previous Clinical Trials
1,148,147 Total Patients Enrolled
15 Trials studying Coronary Artery Disease
47,843 Patients Enrolled for Coronary Artery Disease
Patient-Centered Outcomes Research InstituteOTHER
574 Previous Clinical Trials
27,078,359 Total Patients Enrolled
2 Trials studying Coronary Artery Disease
1,116 Patients Enrolled for Coronary Artery Disease
Icahn School of Medicine at Mount SinaiOTHER
904 Previous Clinical Trials
541,221 Total Patients Enrolled
26 Trials studying Coronary Artery Disease
31,220 Patients Enrolled for Coronary Artery Disease
~400 spots leftby Mar 2033
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