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The Vascular Biology of Dipyridamole in Peripheral Arterial Disease (PAD)

This study has been terminated.
(Could not enroll subjects who met the stringent inclusion/exclusion criteria.)
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00906035
First received: May 20, 2009
Last updated: August 2, 2017
Last verified: August 2017
Results First Received: September 1, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Peripheral Arterial Disease
Interventions: Drug: Dipyridamole 200mg and Aspirin 25mg bid:
Drug: Dipyridamole 200 mg bid
Drug: Aspirin 25 mg bid

  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
No text entered.

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
Dipyridamole 200mg and Aspirin 25mg Bid

All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.

Dipyridamole 200mg and Aspirin 25mg bid:: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.

Dipyridamole 200 mg Bid

All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.

Dipyridamole 200 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.

Aspirin 25 mg Bid

All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy (NIRS) of the legs.

Aspirin 25 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.


Participant Flow:   Overall Study
    Dipyridamole 200mg and Aspirin 25mg Bid   Dipyridamole 200 mg Bid   Aspirin 25 mg Bid
STARTED   8   9   8 
COMPLETED   6 [1]   6 [2]   8 
NOT COMPLETED   2   3   0 
Withdrawal by Subject                2                3                0 
[1] One Drop-Out; SAE day before Visit 1 and One subject Withrew prior to visit 1
[2] 2 subjects Withdrew after Visit 1 and 1 subject Withdrew shortly after Visit 1due to an AE



  Baseline Characteristics
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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
Dipyridamole 200mg and Aspirin 25mg Bid

All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.

Dipyridamole 200mg and Aspirin 25mg bid:: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.

Dipyridamole 200 mg Bid

All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.

Dipyridamole 200 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.

Aspirin 25 mg Bid

All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy (NIRS) of the legs.

Aspirin 25 mg bid: All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.

Total Total of all reporting groups

Baseline Measures
   Dipyridamole 200mg and Aspirin 25mg Bid   Dipyridamole 200 mg Bid   Aspirin 25 mg Bid   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   9   8   25 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      1  12.5%      1  11.1%      1  12.5%      3  12.0% 
>=65 years      7  87.5%      8  88.9%      7  87.5%      22  88.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      1  12.5%      2  22.2%      3  37.5%      6  24.0% 
Male      7  87.5%      7  77.8%      5  62.5%      19  76.0% 
Region of Enrollment 
[Units: Participants]
       
United States   8   9   8   25 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Present Study is Designed to Explore Two Potential Mechanisms Which Have Been Linked to Dipyridamole Action on the Vessel Wall; Modulation of Vascular Eicosanoid Generation and Prevention of Oxidant Stress.   [ Time Frame: Predose and dosing days 30, 90 and 180 ]

2.  Secondary:   Assess the Functional Consequences of Dipyridamole Action, Alone and in Combination With Aspirin Compared With Aspirin Alone on Local Measurements of Flow and Oxygenation. Blood Flow Reporting to Added Table.   [ Time Frame: Predose and dosing days 30, 90 and 180. ]

3.  Secondary:   Assess the Functional Consequences of Dipyridamole Action, Alone and in Combination With Aspirin Compared With Aspirin Alone on Local Measurements of Flow and Oxygenation. Reporting Blood Oxygenation.   [ Time Frame: Predose and dosing days 30, 90 and 180. ]


  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
Study encountered difficulty while attempting to find subjects who met all inclusion/exclusion criteria."0" indicated because no analysis was done on samples obtained. Data could not be analyzed due to insufficient number of participants enrolled.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Emile Mohler, MD
Organization: Upenn
phone: 215-573-6606
e-mail: Emile.Mohler@uphs.upenn.edu



Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00906035     History of Changes
Other Study ID Numbers: 706469
0821
Study First Received: May 20, 2009
Results First Received: September 1, 2016
Last Updated: August 2, 2017