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Procedure

Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes (FREEDOM)

Phase 3
Waitlist Available
Research Sponsored by Valentin Fuster
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at year 5
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

The purpose of this study is to compare 5-year mortality rates in diabetic individuals with multivessel coronary artery disease (CAD) who undergo either coronary artery bypass grafting (CABG) surgery or percutaneous coronary stenting.

Eligible Conditions
  • Diabetes
  • Cardiovascular Disease
  • Single Ventricle Heart Disease
  • Coronary Heart Disease
  • Heart Disease

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
5-year Composite Endpoint of All-cause Mortality, Non-fatal Myocardial Infarction, and Stroke
Secondary study objectives
Rates of Individual MACCE Endpoints

Side effects data

From 2020 Phase 4 trial • 777 Patients • NCT01985360
19%
Death from any cause or Initiation of dialysis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Invasive Strategy
Conservative Strategy

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
Active Control
Group I: Percutaneous Coronary InterventionExperimental Treatment1 Intervention
Percutaneous Coronary Intervention
Group II: Coronary Artery Bypass GraftActive Control1 Intervention
Coronary Artery Bypass Graft
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Percutaneous Coronary Intervention
2013
Completed Phase 4
~460620

Find a Location

Who is running the clinical trial?

Valentin FusterLead Sponsor
2 Previous Clinical Trials
5,739 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,942 Previous Clinical Trials
47,791,353 Total Patients Enrolled
31 Trials studying Diabetes
52,445 Patients Enrolled for Diabetes
~88 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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