Status:
UNKNOWN
Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes (FREEDOM)
Lead Sponsor:
Valentin Fuster
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Diseases
Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
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, a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
1900 Patients enrolled
Trial Details
Trial ID
NCT00086450
Start Date
April 1 2004
End Date
December 1 2018
Last Update
February 6 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029