Effects of Pioglitazone on Platelet Function - Full Text View

Sponsored by:	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	Phase II

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Effects of Pioglitazone on Platelet Function

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

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 ]

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

Intervention Details:

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

Contacts

Contact: Charles Francis, MD

585-275-3761

Charles_Francis@urmc.rochester.edu

Locations

United States, New York
University of Rochester	Recruiting
Rochester, New York, United States, 14642
Contact: Charles Francis, MD 585-275-3761 Charles_Francis@urmc.rochester.edu

Sponsors and Collaborators

University of Rochester

More Information

No publications provided

Responsible Party:	University of Rochester ( Charles Francis, MD )
Study ID Numbers:	24695
Study First Received:	March 9, 2009
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00861341 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Rochester:

Pioglitazone
Thiazolidenediones
Platelet Function
Effects of pioglitazone on platelet aggregation in normal and diabetic patients before and after the administration of aspirin.

Study placed in the following topic categories:

Anti-Inflammatory Agents
Pioglitazone
Cyclooxygenase Inhibitors
Diabetes Mellitus
Fibrinolytic Agents
Healthy
Cardiovascular Agents
Fibrin Modulating Agents

Hypoglycemic Agents
Aspirin
Analgesics, Non-Narcotic
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Pioglitazone
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents

Hypoglycemic Agents
Aspirin
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009