The Effect of Reloading Prasugrel in a Patient Who Has Already Received a Loading Dose (LD) of Clopidogrel (SWITCH 600/60)
|ClinicalTrials.gov Identifier: NCT01365221|
Recruitment Status : Unknown
Verified October 2013 by Medstar Health Research Institute.
Recruitment status was: Active, not recruiting
First Posted : June 3, 2011
Last Update Posted : November 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome||Drug: Prasugrel||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||SWITCH 600/60: The Effect of Reloading Prasugrel in a Patient Who Has Already Received a Loading Dose (LD) of Clopidogrel|
|Study Start Date :||December 2010|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||January 2014|
|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.
- 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. ]
- 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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|