Cardiovascular DiseasesPhase 3NCT00086450
Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes (FREEDOM)
A Phase 3 study testing Coronary Artery Bypass Graft and Percutaneous Coronary Intervention in people with Cardiovascular Diseases and Coronary Disease, run by Valentin Fuster at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Diabetes Mellitus
- What is being tested?
- Coronary Artery Bypass Graft and Percutaneous Coronary Intervention
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,900 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Dec 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diabetes mellitus (Type 1 or Type 2), defined according to the American Diabetes Association as either:
- presence of classic symptoms of diabetes mellitus with unequivocal elevation of plasma glucose (2-hour post-prandial or random of greater than 200 mg/dL (11mmol/L) or
- fasting plasma glucose elevation on more than one occasion of at least 126 mg/dL (7mmol/L)
- Currently undergoing pharmacological or non-pharmacological treatment for diabetes
- Angiographically confirmed multivessel CAD [critical (greater than or equal to 70%) lesions in at least two major epicardial vessels and in at least two separate coronary artery territories (LAD, LCX, RCA)] amenable to either PCI or CABG
- Angiographic characteristics amendable to both PCI/DES and CABG
- Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia
Who cannot join
- Severe congestive heart failure (class III or IV according to New York Heart Association [NYHA] or pulmonary edema)
- Prior CABG surgery
- Prior valve surgery
- Prior PCI with stent implantation within 6 months of study entry
- Stroke within 6 months of study entry; if stroke occurred more than 6 months prior to study entry, must have significant residual neurologic involvement, as reflected in a Rankin Score of greater than 1
- Prior history of significant bleeding (within 6 months of study entry) that may occur during CABG or PCI/DES related anticoagulation
Show all 20Show fewer
- In-stent restenosis of a target vessel
- Two or more chronic total occlusions in major coronary territories
- Left main stenosis (at least 50% diameter stenosis)
- Acute ST-elevation MI (Q-wave) within 72 hours of study entry requiring revascularization
- Abnormal creatine kinase level (greater than twice the normal limit); or abnormal CK-MB level at study entry
- Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g., valve repair/replacement, aneurysmectomy, carotid endarterectomy, or carotid stent)
- Cannot undergo either CABG or PCI/DES because of a coexisting medical condition
- Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
- Intolerance to aspirin or both clopidogrel and ticlopidine
- Dementia with a score of less than 20 on the Mini Mental Status Examination (MMSE)
- Extra-cardiac illness that is expected to limit survival to less than 5 years (e.g., oxygen-dependent chronic obstructive pulmonary disease, active hepatitis, significant hepatic failure, or severe kidney disease)
- Pregnant
- Currently enrolled in another clinical trial
- Unable to attend required follow-up visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Future Revascularization Evaluation in Patients With Diabetes Mellitus: Optimal Management of Multivessel Disease (FREEDOM)
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.
Read the detailed description
BACKGROUND:
The study addresses the critically important problem of how to best revascularize diabetic individuals with multivessel CAD. CAD and diabetes diagnoses are increasing at alarming rates, and much of the information regarding optimal revascularization comes from the Bypass Angioplasty Revascularization Investigation (BARI) study. After five years, data from the BARI study showed 15 excess deaths for every 100 diabetic participants revascularized by percutaneous coronary intervention (PCI) compared to CABG, and at 7 years there were more than 20 deaths. These findings provide compelling evidence for some physicians to conclude that diabetic patients with multivessel disease in need of revascularization are best handled by CABG. But a consensus has not yet been reached because these findings have not been uniformly confirmed by registries and other studies. With the recent introduction of coated stents that significantly reduce or eliminate restenosis, a prevailing belief is that adequate revascularization can be achieved by PCI even in diabetic individuals. New developments in percutaneous techniques should translate to improved prognosis to offset the advantage of CABG seen in the BARI study. Since these new drug eluting stents are not yet approved and are not likely to be on the market for several years, a small window of time exists to gather the evidence to support the strategy that provides optimal revascularization in diabetic individuals.
DESIGN NARRATIVE:
FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) is a multicenter, two-arm, open label, prospective, randomized superiority trial with equal allocation, of 5 years duration with a minimum of 3 years of follow-up. The main objective of the study is to evaluate whether PCI with drug-eluting stenting (PCI/DES) is more or less effective than the existing standard of care, CABG. The study population will consist of 2,400 adults with diabetes mellitus (Type 1 or Type 2) with angiographically confirmed multivessel CAD and morphology amenable to either PCI or CABG, with indication for revascularization based upon symptoms or angina and/or objective evidence of myocardial ischemia. Patients who consent will be randomized on a 1:1 basis either to CABG or multivessel stenting using drug-eluting stents, and followed at 30 days, 1 year, and then annually for at least 3 years, but up to 5 years. A registry of 2000 patients will also be recruited concurrently, comprised of eligible non-consenting patients for the randomized trial. Eligible patients will be randomized to receive either CABG or multivessel stenting using drug-eluting stents. Patients randomized to the PCI/DES arm will receive, at the discretion of the primary physician or interventionalists, either CYPHER Sirolimus eluting stent (Cordis Corporation, Warren, NJ, USA) or the TAXUS paclitaxel-eluting stent (Boston Scientific Corporation, Natick, MA, USA). However, it is intended that only one type of drug-eluting stent be used in a given patient during the course of the trial. The primary outcome of the study is the composite of all-cause mortality, nonfatal myocardial infarction, and stroke at the end of the 5-year patient accrual and follow-up period (minimum follow-up is 3 years). The main secondary endpoint that will be assessed is the 1-year major adverse cardiac and cerebrovascular event (MACCE) rates, including the first of one of the following: death, myocardial infarction, stroke, or repeat revascularization. Additional secondary endpoints include: all-cause and cardiovascular mortality at 1, 2, and 3 years; rates of individual MACCE endpoints at 30 days post-procedure; quality of life at 30 days, 6 months, and annually post-procedure; long term costs and cost-effectiveness.
- Being tested
- Coronary Artery Bypass Graft, Percutaneous Coronary Intervention
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Diabetes Mellitus, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Artery Bypass GraftProcedure or surgery
Also called CABG
For CABG, participants will receive general anesthesia and will have a breathing tube placed in their throat and they will be unconscious during the operation. An incision is made through the chest bone and muscle, which allows the surgeon access to the heart and diseased vessels. The surgeon will use one or more healthy vessels (either from an artery in the shoulder or a vein in the leg) and will bypass the diseased vessel with the healthy vessel(s). This bypass will provide needed blood supply to the heart.
Percutaneous Coronary InterventionDevice
Also called PCI
For PCI, the participant will have two or more drug-eluting stents permanently implanted in their clogged arteries. Drug-eluting stents are coated with a drug that may prevent the disease in the vessel from coming back. The brand names of the stents used in this study are TAXUS and CYPHER.
The participant will receive a local anesthetic. A small puncture will be made and a balloon-tipped catheter is introduced through the small puncture in the leg/arm and advanced through the artery to the diseased heart vessel. The balloon is then inflated to enlarge the opening in the vessel. After enlarging the vessel, the drug-eluting stent will be placed using a similar balloon catheter. This balloon will be inflated, expanding the stent and placing it in the diseased vessel. Once the stent is fully expanded, the balloon is deflated and removed, leaving the stent in place in the artery.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Artery Bypass Graft | Active comparator | Coronary Artery Bypass Graft Receives: Procedure: Coronary Artery Bypass Graft |
| Percutaneous Coronary Intervention | Experimental | Percutaneous Coronary Intervention Receives: Device: Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year Composite Endpoint of All-cause Mortality, Non-fatal Myocardial Infarction, and Stroke
median 3.8 years of follow-up
Measured: Measured at Year 5
Secondary outcomes (3)
Major MACCE Rates, Including the First of One of the Following: Death, Myocardial Infarction, Stroke, or Repeat Revascularization
Measured: Measured at Year 1
All-cause Mortality
Measured: Measured at Year 5
Rates of Individual MACCE Endpoints
Major adverse cardiovascular and cerebrovascular events
Measured: Measured at Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2004 (estimated)
- Study startApr 2004
- Primary completionJul 2012
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valentin Fuster
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Valentin Fuster, Icahn School of Medicine at Mount Sinai
- Investigators
- Valentin Fuster, Study chair, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086450
- Sponsor's protocol ID
- GCO 02-0163
- Other IDs
- U01HL071988, R01 HL71988
- Status last verified
- Dec 2016
- First submitted
- 1 Jul 2004
- Last updated
- 6 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Takahashi K, Serruys PW, Fuster V, Farkouh ME, Spertus JA, Cohen DJ, Park SJ, Park DW, Ahn JM, Onuma Y, Kent DM, Steyerberg EW, van Klaveren D; SYNTAX, BEST, and FREEDOM Trial investigators. External Validation of the FREEDOM Score for Individualized Decision Making Between CABG and PCI. J Am Coll Cardiol. 2022 Apr 19;79(15):1458-1473. doi: 10.1016/j.jacc.2022.01.049.
PubMed 35422242Esper RB, Farkouh ME, Ribeiro EE, Hueb W, Domanski M, Hamza TH, Siami FS, Godoy LC, Mathew V, French J, Fuster V. SYNTAX Score in Patients With Diabetes Undergoing Coronary Revascularization in the FREEDOM Trial. J Am Coll Cardiol. 2018 Dec 11;72(23 Pt A):2826-2837. doi: 10.1016/j.jacc.2018.09.046.
PubMed 30522646Farkouh ME, Domanski M, Dangas GD, Godoy LC, Mack MJ, Siami FS, Hamza TH, Shah B, Stefanini GG, Sidhu MS, Tanguay JF, Ramanathan K, Sharma SK, French J, Hueb W, Cohen DJ, Fuster V; FREEDOM Follow-On Study Investigators. Long-Term Survival Following Multivessel Revascularization in Patients With Diabetes: The FREEDOM Follow-On Study. J Am Coll Cardiol. 2019 Feb 19;73(6):629-638. doi: 10.1016/j.jacc.2018.11.001. Epub 2018 Nov 11.
PubMed 30428398van Diepen S, Fuster V, Verma S, Hamza TH, Siami FS, Goodman SG, Farkouh ME. Dual Antiplatelet Therapy Versus Aspirin Monotherapy in Diabetics With Multivessel Disease Undergoing CABG: FREEDOM Insights. J Am Coll Cardiol. 2017 Jan 17;69(2):119-127. doi: 10.1016/j.jacc.2016.10.043.
PubMed 28081820Dangas GD, Farkouh ME, Sleeper LA, Yang M, Schoos MM, Macaya C, Abizaid A, Buller CE, Devlin G, Rodriguez AE, Lansky AJ, Siami FS, Domanski M, Fuster V; FREEDOM Investigators. Long-term outcome of PCI versus CABG in insulin and non-insulin-treated diabetic patients: results from the FREEDOM trial. J Am Coll Cardiol. 2014 Sep 23;64(12):1189-97. doi: 10.1016/j.jacc.2014.06.1182.
PubMed 25236509Abdallah MS, Wang K, Magnuson EA, Spertus JA, Farkouh ME, Fuster V, Cohen DJ; FREEDOM Trial Investigators. Quality of life after PCI vs CABG among patients with diabetes and multivessel coronary artery disease: a randomized clinical trial. JAMA. 2013 Oct 16;310(15):1581-90. doi: 10.1001/jama.2013.279208.
PubMed 24129463Farkouh ME, Boden WE, Bittner V, Muratov V, Hartigan P, Ogdie M, Bertolet M, Mathewkutty S, Teo K, Maron DJ, Sethi SS, Domanski M, Frye RL, Fuster V. Risk factor control for coronary artery disease secondary prevention in large randomized trials. J Am Coll Cardiol. 2013 Apr 16;61(15):1607-15. doi: 10.1016/j.jacc.2013.01.044.
PubMed 23500281Magnuson EA, Farkouh ME, Fuster V, Wang K, Vilain K, Li H, Appelwick J, Muratov V, Sleeper LA, Boineau R, Abdallah M, Cohen DJ; FREEDOM Trial Investigators. Cost-effectiveness of percutaneous coronary intervention with drug eluting stents versus bypass surgery for patients with diabetes mellitus and multivessel coronary artery disease: results from the FREEDOM trial. Circulation. 2013 Feb 19;127(7):820-31. doi: 10.1161/CIRCULATIONAHA.112.147488. Epub 2012 Dec 31.
PubMed 23277307Farkouh ME, Domanski M, Sleeper LA, Siami FS, Dangas G, Mack M, Yang M, Cohen DJ, Rosenberg Y, Solomon SD, Desai AS, Gersh BJ, Magnuson EA, Lansky A, Boineau R, Weinberger J, Ramanathan K, Sousa JE, Rankin J, Bhargava B, Buse J, Hueb W, Smith CR, Muratov V, Bansilal S, King S 3rd, Bertrand M, Fuster V; FREEDOM Trial Investigators. Strategies for multivessel revascularization in patients with diabetes. N Engl J Med. 2012 Dec 20;367(25):2375-84. doi: 10.1056/NEJMoa1211585. Epub 2012 Nov 4.
PubMed 23121323Bansilal S, Farkouh ME, Hueb W, Ogdie M, Dangas G, Lansky AJ, Cohen DJ, Magnuson EA, Ramanathan K, Tanguay JF, Muratov V, Sleeper LA, Domanski M, Bertrand ME, Fuster V. The Future REvascularization Evaluation in patients with Diabetes mellitus: optimal management of Multivessel disease (FREEDOM) trial: clinical and angiographic profile at study entry. Am Heart J. 2012 Oct;164(4):591-9. doi: 10.1016/j.ahj.2012.06.012.
PubMed 23067919
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Future Revascularization Evaluation in Patients With Diabetes Mellitus: Optimal Management of Multivessel Disease (FREEDOM)
- ClinicalTrials.gov ID
- NCT00086450
- Acronym / sponsor ID
- GCO 02-0163
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,900 participants (actual)
- Lead sponsor
- Valentin FusterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2004
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Jul 2004 (estimated)
- Results
- Posted 6 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND:
The study addresses the critically important problem of how to best revascularize diabetic individuals with multivessel CAD. CAD and diabetes diagnoses are increasing at alarming rates, and much of the information regarding optimal revascularization comes from the Bypass Angioplasty Revascularization Investigation (BARI) study. After five years, data from the BARI study showed 15 excess deaths for every 100 diabetic participants revascularized by percutaneous coronary intervention (PCI) compared to CABG, and at 7 years there were more than 20 deaths. These findings provide compelling evidence for some physicians to conclude that diabetic patients with multivessel disease in need of revascularization are best handled by CABG. But a consensus has not yet been reached because these findings have not been uniformly confirmed by registries and other studies. With the recent introduction of coated stents that significantly reduce or eliminate restenosis, a prevailing belief is that adequate revascularization can be achieved by PCI even in diabetic individuals. New developments in percutaneous techniques should translate to improved prognosis to offset the advantage of CABG seen in the BARI study. Since these new drug eluting stents are not yet approved and are not likely to be on the market for several years, a small window of time exists to gather the evidence to support the strategy that provides optimal revascularization in diabetic individuals.
DESIGN NARRATIVE:
FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) is a multicenter, two-arm, open label, prospective, randomized superiority trial with equal allocation, of 5 years duration with a minimum of 3 years of follow-up. The main objective of the study is to evaluate whether PCI with drug-eluting stenting (PCI/DES) is more or less effective than the existing standard of care, CABG. The study population will consist of 2,400 adults with diabetes mellitus (Type 1 or Type 2) with angiographically confirmed multivessel CAD and morphology amenable to either PCI or CABG, with indication for revascularization based upon symptoms or angina and/or objective evidence of myocardial ischemia. Patients who consent will be randomized on a 1:1 basis either to CABG or multivessel stenting using drug-eluting stents, and followed at 30 days, 1 year, and then annually for at least 3 years, but up to 5 years. A registry of 2000 patients will also be recruited concurrently, comprised of eligible non-consenting patients for the randomized trial. Eligible patients will be randomized to receive either CABG or multivessel stenting using drug-eluting stents. Patients randomized to the PCI/DES arm will receive, at the discretion of the primary physician or interventionalists, either CYPHER Sirolimus eluting stent (Cordis Corporation, Warren, NJ, USA) or the TAXUS paclitaxel-eluting stent (Boston Scientific Corporation, Natick, MA, USA). However, it is intended that only one type of drug-eluting stent be used in a given patient during the course of the trial. The primary outcome of the study is the composite of all-cause mortality, nonfatal myocardial infarction, and stroke at the end of the 5-year patient accrual and follow-up period (minimum follow-up is 3 years). The main secondary endpoint that will be assessed is the 1-year major adverse cardiac and cerebrovascular event (MACCE) rates, including the first of one of the following: death, myocardial infarction, stroke, or repeat revascularization. Additional secondary endpoints include: all-cause and cardiovascular mortality at 1, 2, and 3 years; rates of individual MACCE endpoints at 30 days post-procedure; quality of life at 30 days, 6 months, and annually post-procedure; long term costs and cost-effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Bypass Graft | Active comparator | Procedure: Coronary Artery Bypass GraftCoronary Artery Bypass Graft |
| Percutaneous Coronary Intervention | Experimental | Device: Percutaneous Coronary InterventionPercutaneous Coronary Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diabetes mellitus (Type 1 or Type 2), defined according to the American Diabetes Association as either:
- Currently undergoing pharmacological or non-pharmacological treatment for diabetes
- Angiographically confirmed multivessel CAD [critical (greater than or equal to 70%) lesions in at least two major epicardial vessels and in at least two separate coronary artery territories (LAD, LCX, RCA)] amenable to either PCI or CABG
- Angiographic characteristics amendable to both PCI/DES and CABG
- Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia
Key exclusion criteria (20 listed)
- Severe congestive heart failure (class III or IV according to New York Heart Association [NYHA] or pulmonary edema)
- Prior CABG surgery
- Prior valve surgery
- Prior PCI with stent implantation within 6 months of study entry
- Stroke within 6 months of study entry; if stroke occurred more than 6 months prior to study entry, must have significant residual neurologic involvement, as reflected in a Rankin Score of greater than 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary Artery Bypass GraftAlso: CABGFor CABG, participants will receive general anesthesia and will have a breathing tube placed in their throat and they will be unconscious during the operation. An incision is made through the chest bone and muscle, which allows the surgeon access to the heart and diseased vessels. The surgeon will use one or more healthy vessels (either from an artery in the shoulder or a vein in the leg) and will bypass the diseased vessel with the healthy vessel(s). This bypass will provide needed blood supply to the heart. | Procedure or surgery | Coronary Artery Bypass Graft |
| Percutaneous Coronary InterventionAlso: PCIFor PCI, the participant will have two or more drug-eluting stents permanently implanted in their clogged arteries. Drug-eluting stents are coated with a drug that may prevent the disease in the vessel from coming back. The brand names of the stents used in this study are TAXUS and CYPHER. The participant will receive a local anesthetic. A small puncture will be made and a balloon-tipped catheter is introduced through the small puncture in the leg/arm and advanced through the artery to the diseased heart vessel. The balloon is then inflated to enlarge the opening in the vessel. After enlarging the vessel, the drug-eluting stent will be placed using a similar balloon catheter. This balloon will be inflated, expanding the stent and placing it in the diseased vessel. Once the stent is fully expanded, the balloon is deflated and removed, leaving the stent in place in the artery. | Device | Percutaneous Coronary Intervention |
Primary outcome
5-year Composite Endpoint of All-cause Mortality, Non-fatal Myocardial Infarction, and Stroke
Time frame: Measured at Year 5
median 3.8 years of follow-up
3 secondary outcomes
Major MACCE Rates, Including the First of One of the Following: Death, Myocardial Infarction, Stroke, or Repeat Revascularization
Time frame: Measured at Year 1
All-cause Mortality
Time frame: Measured at Year 5
Rates of Individual MACCE Endpoints
Time frame: Measured at Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35422242Takahashi K, Serruys PW, Fuster V, Farkouh ME, Spertus JA, Cohen DJ, Park SJ, Park DW, Ahn JM, Onuma Y, Kent DM, Steyerberg EW, van Klaveren D; SYNTAX, BEST, and FREEDOM Trial investigators. External Validation of the FREEDOM Score for Individualized Decision Making Between CABG and PCI. J Am Coll Cardiol. 2022 Apr 19;79(15):1458-1473. doi: 10.1016/j.jacc.2022.01.049.
- Derived from this study: PubMed 30522646Esper RB, Farkouh ME, Ribeiro EE, Hueb W, Domanski M, Hamza TH, Siami FS, Godoy LC, Mathew V, French J, Fuster V. SYNTAX Score in Patients With Diabetes Undergoing Coronary Revascularization in the FREEDOM Trial. J Am Coll Cardiol. 2018 Dec 11;72(23 Pt A):2826-2837. doi: 10.1016/j.jacc.2018.09.046.
- Derived from this study: PubMed 30428398Farkouh ME, Domanski M, Dangas GD, Godoy LC, Mack MJ, Siami FS, Hamza TH, Shah B, Stefanini GG, Sidhu MS, Tanguay JF, Ramanathan K, Sharma SK, French J, Hueb W, Cohen DJ, Fuster V; FREEDOM Follow-On Study Investigators. Long-Term Survival Following Multivessel Revascularization in Patients With Diabetes: The FREEDOM Follow-On Study. J Am Coll Cardiol. 2019 Feb 19;73(6):629-638. doi: 10.1016/j.jacc.2018.11.001. Epub 2018 Nov 11.
- Derived from this study: PubMed 28081820van Diepen S, Fuster V, Verma S, Hamza TH, Siami FS, Goodman SG, Farkouh ME. Dual Antiplatelet Therapy Versus Aspirin Monotherapy in Diabetics With Multivessel Disease Undergoing CABG: FREEDOM Insights. J Am Coll Cardiol. 2017 Jan 17;69(2):119-127. doi: 10.1016/j.jacc.2016.10.043.
- Derived from this study: PubMed 25236509Dangas GD, Farkouh ME, Sleeper LA, Yang M, Schoos MM, Macaya C, Abizaid A, Buller CE, Devlin G, Rodriguez AE, Lansky AJ, Siami FS, Domanski M, Fuster V; FREEDOM Investigators. Long-term outcome of PCI versus CABG in insulin and non-insulin-treated diabetic patients: results from the FREEDOM trial. J Am Coll Cardiol. 2014 Sep 23;64(12):1189-97. doi: 10.1016/j.jacc.2014.06.1182.
- Derived from this study: PubMed 24129463Abdallah MS, Wang K, Magnuson EA, Spertus JA, Farkouh ME, Fuster V, Cohen DJ; FREEDOM Trial Investigators. Quality of life after PCI vs CABG among patients with diabetes and multivessel coronary artery disease: a randomized clinical trial. JAMA. 2013 Oct 16;310(15):1581-90. doi: 10.1001/jama.2013.279208.
- Derived from this study: PubMed 23500281Farkouh ME, Boden WE, Bittner V, Muratov V, Hartigan P, Ogdie M, Bertolet M, Mathewkutty S, Teo K, Maron DJ, Sethi SS, Domanski M, Frye RL, Fuster V. Risk factor control for coronary artery disease secondary prevention in large randomized trials. J Am Coll Cardiol. 2013 Apr 16;61(15):1607-15. doi: 10.1016/j.jacc.2013.01.044.
- Derived from this study: PubMed 23277307Magnuson EA, Farkouh ME, Fuster V, Wang K, Vilain K, Li H, Appelwick J, Muratov V, Sleeper LA, Boineau R, Abdallah M, Cohen DJ; FREEDOM Trial Investigators. Cost-effectiveness of percutaneous coronary intervention with drug eluting stents versus bypass surgery for patients with diabetes mellitus and multivessel coronary artery disease: results from the FREEDOM trial. Circulation. 2013 Feb 19;127(7):820-31. doi: 10.1161/CIRCULATIONAHA.112.147488. Epub 2012 Dec 31.
- Derived from this study: PubMed 23121323Farkouh ME, Domanski M, Sleeper LA, Siami FS, Dangas G, Mack M, Yang M, Cohen DJ, Rosenberg Y, Solomon SD, Desai AS, Gersh BJ, Magnuson EA, Lansky A, Boineau R, Weinberger J, Ramanathan K, Sousa JE, Rankin J, Bhargava B, Buse J, Hueb W, Smith CR, Muratov V, Bansilal S, King S 3rd, Bertrand M, Fuster V; FREEDOM Trial Investigators. Strategies for multivessel revascularization in patients with diabetes. N Engl J Med. 2012 Dec 20;367(25):2375-84. doi: 10.1056/NEJMoa1211585. Epub 2012 Nov 4.
- Derived from this study: PubMed 23067919Bansilal S, Farkouh ME, Hueb W, Ogdie M, Dangas G, Lansky AJ, Cohen DJ, Magnuson EA, Ramanathan K, Tanguay JF, Muratov V, Sleeper LA, Domanski M, Bertrand ME, Fuster V. The Future REvascularization Evaluation in patients with Diabetes mellitus: optimal management of Multivessel disease (FREEDOM) trial: clinical and angiographic profile at study entry. Am Heart J. 2012 Oct;164(4):591-9. doi: 10.1016/j.ahj.2012.06.012.
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Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentin Fuster study chair
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Coronary Artery Bypass Graft and Percutaneous Coronary Intervention in people with Cardiovascular Diseases and Coronary Disease, run by Valentin Fuster at 1 site 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 7 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 6 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year Composite Endpoint of All-cause Mortality, Non-fatal Myocardial Infarction, and Stroke (time frame: Measured at Year 5). 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 NCT00086450, which also lists 10 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 6 Feb 2017.