Effects of Pioglitazone on Platelet Function - Full Text View

Sponsor:	University of Rochester
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00861341

Purpose

The purpose of this study is to determine how pioglitazone and aspirin affect platelets in the blood of diabetic and non-diabetic subjects. Platelets are small cells in the blood that help with blood clotting. Pioglitazone is a drug that is used to lower blood sugar and fats by helping the body to use insulin correctly. Pioglitazone is presently used to treat diabetes but has not been approved for non-diabetics. This study will determine whether pioglitazone reduces the activity of platelets in people who are or are not also taking aspirin.

Condition	Intervention	Phase
Diabetes Platelet Aggregation Healthy	Drug: pioglitazone and aspirin Drug: Pioglitazone Drug: Pioglitazone + 81mg Aspirin	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Effects of Pioglitazone on Platelet Function

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines

Drug Information available for: Acetylsalicylic acid Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

To determine how pioglitazone and aspirin affect platelets in the blood of diabetic and non-diabetic subjects. [ Time Frame: 6-9 days ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pioglitazone 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.	Drug: Pioglitazone 30mg Pioglitazone x1 Other Name: Actos
Experimental: Pioglitazone + 81mg Aspirin 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.	Drug: pioglitazone and 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. Other Names: Actos 81mg Aspirin Drug: Pioglitazone + 81mg Aspirin 30mg Pioglitazone Other Names: Actos Adult low dose Aspirin

Arms

Assigned Interventions

Experimental: Pioglitazone

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.

Drug: Pioglitazone

30mg Pioglitazone x1

Other Name: Actos

Experimental: Pioglitazone + 81mg Aspirin

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.

Drug: pioglitazone and 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.

Other Names:

Actos
81mg Aspirin

Drug: Pioglitazone + 81mg Aspirin

30mg Pioglitazone

Other Names:

Actos
Adult low dose Aspirin

Detailed 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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects must be over 21 years of age and provide written informed consent.
Normal subjects must have a BMI <30 and must not have known cardiovascular disease, Diabetes Mellitus (DM), hyperlipidemia, or hypertension. Diabetic subjects must have previously diagnosed DM.

Exclusion Criteria:

Subjects will be excluded if they have hypersensitivity to aspirin or pioglitazone, or if they are receiving warfarin or heparin therapy, are pregnant, or have congestive heart failure or hepatic function impairment.
Subjects must not have taken aspirin or other drugs inhibiting platelet function such as Plavix or non-steroidal anti-inflammatory drugs for 7 days.
Subjects will be excluded if they have a history of renal failure, severe liver disease, myeloproliferative disease or other conditions that impair platelet function.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861341

Locations

United States, New York
University of Rochester
Rochester, New York, United States, 14642

Sponsors and Collaborators

University of Rochester

Investigators

Principal Investigator:

Charles W Francis, MD

University of Rochester

More Information

No publications provided

Responsible Party:	Charles Francis, MD, University of Rochester
ClinicalTrials.gov Identifier:	NCT00861341 History of Changes
Other Study ID Numbers:	24695
Study First Received:	March 9, 2009
Last Updated:	August 4, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Rochester:

Pioglitazone
Thiazolidinediones
Platelet Function

Platelet aggregation
Diabetic
Aspirin.

Additional relevant MeSH terms:

Aspirin
Pioglitazone
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents

Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Hypoglycemic Agents

ClinicalTrials.gov processed this record on February 09, 2012