Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes (FREEDOM)
Status unconfirmed · Phase 3
Conditions studied: Cardiovascular Diseases, Coronary Disease, Diabetes Mellitus, Heart Diseases
In brief
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.
Key facts
- Study ID
- NCT00086450
- Run by
- Valentin Fuster
- People needed
- 1900
- Starts
- 2004-04-01
- Expected to finish
- 2018-12-01
- Last updated by the study team
- 2017-02-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- 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
Where it is running
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
Full record on ClinicalTrials.gov
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