Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 29 for:    stem cell peripheral arterial disease | ( Map: United States )

Assessment Of Vascular Health After Niacin Therapy (AVANT) (AVANT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02003638
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : June 25, 2014
Last Update Posted : June 25, 2014
Sponsor:
Information provided by (Responsible Party):
Emil deGoma, University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator)
Conditions Coronary Artery Disease
Carotid Artery Disease
Peripheral Artery Disease
Interventions Drug: Niacin
Drug: Placebo
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Niacin Placebo
Hide Arm/Group Description Niacin titrated up to 6 grams taken orally every day for 12 weeks Placebo taken orally every day for 12 weeks
Period Title: Overall Study
Started 6 3
Completed 5 [1] 3
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
[1]
1 withdrew after developing bacterial pharyngitis. Not considered treatment-emergent.
Arm/Group Title Niacin Placebo Total
Hide Arm/Group Description Niacin titrated up to 6 grams taken orally every day for 12 weeks Placebo taken orally every day for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 5 3 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants 3 participants 8 participants
63
(56 to 67)
66
(64 to 69)
64
(56 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 8 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
5
 100.0%
3
 100.0%
8
 100.0%
Body-mass index  
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 5 participants 3 participants 8 participants
28.9
(23.7 to 33.1)
32
(25.6 to 33.4)
30.0
(23.7 to 33.4)
Coronary artery disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 8 participants
5 3 8
1.Primary Outcome
Title Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Niacin Placebo
Hide Arm/Group Description:
Niacin titrated up to 6 grams taken orally every day for 12 weeks
Placebo taken orally every day for 12 weeks
Overall Number of Participants Analyzed 5 3
Mean (Standard Deviation)
Unit of Measure: Target to Background Ratio (TBR)
-0.02  (.14) -0.05  (.12)
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Niacin Placebo
Hide Arm/Group Description Niacin titrated up to 6 grams taken orally every day for 12 weeks Placebo taken orally every day for 12 weeks
All-Cause Mortality
Niacin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Niacin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      0/3 (0.00%)    
General disorders     
Abdominal pain * [1]  1/5 (20.00%)  1 0/3 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
At week 11, hospitalized for abdominal discomfort, nausea, chest pain. Vital signs, serial ECG, cardiac enzymes, chest radiography, and hemoglobin were normal. His symptoms resolved spontaneously within 24 hours without cessation of study drug.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Niacin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/5 (60.00%)      0/3 (0.00%)    
Infections and infestations     
Rocky Mountain Spotted Fever *  1/5 (20.00%)  1 0/3 (0.00%)  0
Bacterial pharyngitis *  1/5 (20.00%)  1 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Chronic pulmonary embolism * [1]  1/5 (20.00%)  1 0/3 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Asymptomatic. Incidental finding of chronic pulmonary emboli on baseline CT
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Emil deGoma
Organization: University of Pennsylvania
Phone: 2156156521
EMail: emil.degoma@uphs.upenn.edu
Layout table for additonal information
Responsible Party: Emil deGoma, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02003638     History of Changes
Other Study ID Numbers: 812962
First Submitted: November 18, 2013
First Posted: December 6, 2013
Results First Submitted: May 22, 2014
Results First Posted: June 25, 2014
Last Update Posted: June 25, 2014