Try our beta test site

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Valentin Fuster, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT00086450
First received: July 1, 2004
Last updated: December 9, 2016
Last verified: December 2016
Results First Received: September 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cardiovascular Diseases
Coronary Disease
Diabetes Mellitus
Heart Diseases
Interventions: Procedure: Coronary Artery Bypass Graft
Device: Percutaneous Coronary Intervention

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All trial-eligible patients must have multivessel disease suitable for either approach as determined by both an interventional cardiologist and a surgical investigator. The interventionalist and surgeon at each site will document their intentions of which vessels are targets for revascularization.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Percutaneous Coronary Intervention Percutaneous Coronary Intervention
Coronary Artery Bypass Graft Coronary Artery Bypass Graft

Participant Flow:   Overall Study
    Percutaneous Coronary Intervention   Coronary Artery Bypass Graft
STARTED   953   947 
COMPLETED   953   947 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Percutaneous Coronary Intervention Percutaneous Coronary Intervention
Coronary Artery Bypass Graft Coronary Artery Bypass Graft
Total Total of all reporting groups

Baseline Measures
   Percutaneous Coronary Intervention   Coronary Artery Bypass Graft   Total 
Overall Participants Analyzed 
[Units: Participants]
 953   947   1900 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.2  (8.9)   63.1  (9.2)   63.1  (9.1) 
Gender 
[Units: Participants]
Count of Participants
     
Female      255  26.8%      289  30.5%      544  28.6% 
Male      698  73.2%      658  69.5%      1356  71.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   5-year Composite Endpoint of All-cause Mortality, Non-fatal Myocardial Infarction, and Stroke   [ Time Frame: Measured at Year 5 ]

2.  Secondary:   Major MACCE Rates, Including the First of One of the Following: Death, Myocardial Infarction, Stroke, or Repeat Revascularization   [ Time Frame: Measured at Year 1 ]

3.  Secondary:   All-cause Mortality   [ Time Frame: Measured at Year 5 ]

4.  Secondary:   Rates of Individual MACCE Endpoints   [ Time Frame: Measured at Day 30 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Since the trial was not blinded, patients may have been treated differently on the basis of their surgical procedure.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Valentin Fuster, M.D., Ph.D.
Organization: Icahn School of Medicine at Mount Sinai
phone: 212-860-1056
e-mail: valentin.fuster@mssm.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Valentin Fuster, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00086450     History of Changes
Other Study ID Numbers: GCO 02-0163
U01HL071988 ( US NIH Grant/Contract Award Number )
R01 HL71988
Study First Received: July 1, 2004
Results First Received: September 13, 2016
Last Updated: December 9, 2016