Effects of Pioglitazone on Platelet Function
Information source: University of Rochester
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes; Platelet Aggregation; Healthy
Intervention: pioglitazone and aspirin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Rochester Overall contact:
Charles Francis, MD, Phone: 585-275-3761, Email: Charles_Francis@urmc.rochester.edu
Summary
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.
Clinical Details
Official title: Effects of Pioglitazone on Platelet Function
Study design: Diagnostic, Non-Randomized, Open Label, Single Group Assignment
Primary outcome: To determine how pioglitazone and aspirin affect platelets in the blood of diabetic and non-diabetic subjects.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Charles Francis, MD, Phone: 585-275-3761, Email: Charles_Francis@urmc.rochester.edu
University of Rochester, Rochester, New York 14642, United States; Recruiting
Charles Francis, MD, Phone: 585-275-3761, Email: Charles_Francis@urmc.rochester.edu
Additional Information
Starting date: December 2008
Last updated: March 12, 2009
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