The Effect of Reloading Prasugrel in a Patient Who Has Already Received a Loading Dose (LD) of Clopidogrel

Completed · Phase 4

Conditions studied: Acute Coronary Syndrome

In brief

The primary objective of this study is to compare platelet reactivity between patients receiving a loading dose of clopidogrel and a reloading dose of prasugrel to patients receiving only a loading dose of prasugrel.

Key facts

Study ID

NCT01365221

Run by

Medstar Health Research Institute

People needed

77

Starts

2010-10-01

Expected to finish

2014-01-01

Last updated by the study team

2020-09-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients age 18 or older, of both genders
• Presenting with an ACS, defined as at least two of the following:
• Symptoms consistent with myocardial ischemia; ST segment elevation or depression of at least 1 mm in 2 or more contiguous leads on EKG; Cardiac troponin I level above the upper limit of normal.
• An initial invasive strategy (e.g. early angiography) is planned.
• No contraindications to prasugrel therapy.

You may not qualify if…

• Known allergies to aspirin, clopidogrel, or prasugrel.
• Patient known to be pregnant or lactating.
• Patient with known history of bleeding diathesis, or currently active bleeding.
• Platelet count <100,000/mm3 at the time of enrollment.
• Hematocrit <25% at the time of enrollment.
• On warfarin therapy at the time of PCI, or patient likely to require warfarin therapy post-PCI.
• Received fibrinolytics within the past 48 hours.
• Received a glycoprotein IIb/IIIa inhibitor within the past 48 hours, or if a strategy for PCI involving a glycoprotein IIb/IIIa inhibitor is planned.
• Taking maintenance thienopyridine therapy in the previous 7 days.
• Known blood transfusion within the preceding 10 days.
• Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS) within the previous 5 days.
• Patients with known chronic liver disease.
• Age greater than 75 years.
• Body weight less than 60 kg.
• History of stroke or transient ischemic attack.
• Surgery planned within 1 month.
• Patient likely to require coronary artery bypass grafting.
• Any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.

Where it is running

• The Heart Center — Huntsville, Alabama, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Sinai Center for Thrombosis Research — Baltimore, Maryland, United States
• Saint Luke's Hospital — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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