Trial Outcomes & Findings for Effects of Pioglitazone on Platelet Function (NCT NCT00861341)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

at baseline and days 6-9

Results posted on

2016-02-03

Participant Flow

Participant milestones

Participant milestones
Measure	Pioglitazone With or Without 81mg Aspirin 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 Study STARTED	40
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Pioglitazone With or Without 81mg Aspirin 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 Study Withdrawal by Subject	2

Baseline Characteristics

Effects of Pioglitazone on Platelet Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pioglitazone With or Without 81mg Aspirin n=40 Participants 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.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=99 Participants
Age, Categorical >=65 years	6 Participants n=99 Participants
Age, Continuous	49 years STANDARD_DEVIATION 32 • n=99 Participants
Sex: Female, Male Female	23 Participants n=99 Participants
Sex: Female, Male Male	17 Participants n=99 Participants
Region of Enrollment United States	40 participants n=99 Participants

PRIMARY outcome

Timeframe: at baseline and days 6-9

Population: Analysis population determined per protocol.

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.

Outcome measures

Outcome measures
Measure	Pioglitazone With or Without 81mg Aspirin n=40 Participants 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.
Percent Platelet Aggregation Induced by Arachidonic Acid Sample 1	80 maximum percentage aggregation Standard Deviation 5
Percent Platelet Aggregation Induced by Arachidonic Acid Sample 2	90 maximum percentage aggregation Standard Deviation 3
Percent Platelet Aggregation Induced by Arachidonic Acid Sample 3	60 maximum percentage aggregation Standard Deviation 6
Percent Platelet Aggregation Induced by Arachidonic Acid Sample 4	29 maximum percentage aggregation Standard Deviation 6

PRIMARY outcome

Timeframe: baseline and day 6-9

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.

Outcome measures

Outcome measures
Measure	Pioglitazone With or Without 81mg Aspirin n=40 Participants 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.
Percent Platelet Aggregation Induced by Collagen Sample 1	89 maximum percentage aggregation Standard Deviation 3
Percent Platelet Aggregation Induced by Collagen Sample 2	93 maximum percentage aggregation Standard Deviation 2
Percent Platelet Aggregation Induced by Collagen Sample 3	83 maximum percentage aggregation Standard Deviation 3
Percent Platelet Aggregation Induced by Collagen Sample 4	78 maximum percentage aggregation Standard Deviation 3

Adverse Events

Pioglitazone With or Without 81mg Aspirin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Charles Francis, MD

University of Rochester, Wilmot Cancer Center

Phone: 585-275-3761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60