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Trial record 8 of 1254 for:    ASPIRIN AND Platelet Aggregation

Effects of Pioglitazone on Platelet Function (UHEM08014)

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ClinicalTrials.gov Identifier: NCT00861341
Recruitment Status : Completed
First Posted : March 13, 2009
Results First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
Charles Francis, University of Rochester

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Diabetes
Platelet Function
Healthy
Interventions Drug: Aspirin
Drug: Pioglitazone
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pioglitazone With or Without 81mg Aspirin
Hide Arm/Group Description Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
Period Title: Overall Study
Started 40
Completed 38
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Pioglitazone With or Without 81mg Aspirin
Hide Arm/Group Description Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
34
  85.0%
>=65 years
6
  15.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
49  (32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
23
  57.5%
Male
17
  42.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
1.Primary Outcome
Title Percent Platelet Aggregation Induced by Arachidonic Acid
Hide Description Platelet aggregation was performed by the turbidimetric method of Born with simultaneous measurement of ATP release using a Chrono-log Lumi-Aggregometer with AGGRO/LINK for Windows Software version 5.1.6. Platelet rich plasma was placed in a silicone-coated cuvette with constant stirring at 1200 rpm using a siliconized stir bar for measurement of aggregation and ATP release. Aggregation was initiated using arachidonic acid (0.5 mM). At each time point the results are shown for maximum percent aggregation with arachidonic acid for all subjects. Sample 1 was obtained at baseline (BL). Sample 2 was drawn on the same day after ingestion of a single dose of 30 mg of pioglitazone. Sample 3 was obtained 6–9 days later after the subject had ingested a single 81 mg dose of aspirin (ASA), and sample 4 was drawn later that day after ingestion of 30 mg of pioglitazone.
Time Frame at baseline and days 6-9
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population determined per protocol.
Arm/Group Title Pioglitazone With or Without 81mg Aspirin
Hide Arm/Group Description:
Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: maximum percentage aggregation
Sample 1 80  (5)
Sample 2 90  (3)
Sample 3 60  (6)
Sample 4 29  (6)
2.Primary Outcome
Title Percent Platelet Aggregation Induced by Collagen
Hide Description Platelet aggregation was performed by the turbidimetric method of Born with simultaneous measurement of ATP release using a Chrono-log Lumi-Aggregometer with AGGRO/LINK for Windows Software version 5.1.6. Platelet rich plasma was placed in a silicone-coated cuvette with constant stirring at 1200 rpm using a siliconized stir bar for measurement of aggregation and ATP release. Aggregation was initiated using collagen (2ug.mL). At each time point the results are shown for maximum percent aggregation with collagen for all subjects. Sample 1 was obtained at baseline (BL). Sample 2 was drawn on the same day after ingestion of a single dose of 30 mg of pioglitazone. Sample 3 was obtained 6–9 days later after the subject had ingested a single 81 mg dose of aspirin (ASA), and sample 4 was drawn later that day after ingestion of 30 mg of pioglitazone.
Time Frame baseline and day 6-9
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone With or Without 81mg Aspirin
Hide Arm/Group Description:
Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: maximum percentage aggregation
Sample 1 89  (3)
Sample 2 93  (2)
Sample 3 83  (3)
Sample 4 78  (3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pioglitazone With or Without 81mg Aspirin
Hide Arm/Group Description Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
All-Cause Mortality
Pioglitazone With or Without 81mg Aspirin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pioglitazone With or Without 81mg Aspirin
Affected / at Risk (%)
Total   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pioglitazone With or Without 81mg Aspirin
Affected / at Risk (%)
Total   0/40 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Charles Francis, MD
Organization: University of Rochester, Wilmot Cancer Center
Phone: 585-275-3761
Responsible Party: Charles Francis, University of Rochester
ClinicalTrials.gov Identifier: NCT00861341     History of Changes
Other Study ID Numbers: 24695
First Submitted: March 9, 2009
First Posted: March 13, 2009
Results First Submitted: June 21, 2011
Results First Posted: February 3, 2016
Last Update Posted: February 3, 2016