The Effect of Reloading Prasugrel in a Patient Who Has Already Received a Loading Dose (LD) of Clopidogrel (SWITCH 600/60)
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||SWITCH 600/60: The Effect of Reloading Prasugrel in a Patient Who Has Already Received a Loading Dose (LD) of Clopidogrel|
- The primary objective is to compare platelet reactivity, as assessed by the VerifyNow P2Y12 assay, between patients receiving a loading dose of clopidogrel and a reloading dose of prasugrel to patients receiving only a loading dose of prasugrel. [ Time Frame: Average hospital stay is 24-48 hours. ] [ Designated as safety issue: Yes ]
- The secondary objective of this study is to describe rates of bleeding events associated with a loading dose of prasugrel in patients who have already received a loading dose of clopidogrel. [ Time Frame: Average hospital stay is 24-48 hours. ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
|Experimental: Patients who have received loading dose of clopidogrel||
Patients who have received 600 mg loading dose of clopidogrel will receive a reloading dose of 60 mg prasugrel
|Active Comparator: Patients who have not received loading dose of clopidogrel||
Patients who have not received a loading dose of clopidogrel will receive a 60 mg loading dose of prasugrel.
This is a prospective, open-label, non-randomized trial of approximately 260 patients with Acute Coronary Syndrome (ACS) undergoing percutaneous coronary intervention (PCI). In order to compare platelet reactivity, as assessed by the VerifyNow P2Y12 assay, we plan to recruit two study groups of interest:
- Patients who have already received a 600 mg loading dose (LD) of clopidogrel in preparation for PCI will receive a loading dose of 60 mg of prasugrel.
- Patients who have not received a LD of clopidogrel will receive a 60 mg LD of prasugrel prior to PCI.
A subset of 40 patients from each study group (80 patients total) will undergo additional platelet reactivity testing with the vasodilator stimulated phosphoprotein (VASP) assay.All patients will be followed throughout the duration of the hospital stay.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365221
|United States, Alabama|
|The Heart Center|
|Huntsville, Alabama, United States, 35801|
|United States, District of Columbia|
|Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|United States, Maryland|
|Sinai Center for Thrombosis Research|
|Baltimore, Maryland, United States, 21215|
|United States, Missouri|
|Saint Luke's Hospital|
|Kansas City, Missouri, United States, 64111|
|Principal Investigator:||Ron Waksman, MD||Medstar Washington Hospital Center|