NCT01365221

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

SWITCH 600/60: The Effect of Reloading Prasugrel in a Patient Who Has Already Received a Loading Dose (LD) of Clopidogrel

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: 1. 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. 2. 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.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Prasugrel	Patients who have received 600 mg loading dose of clopidogrel will receive a reloading dose of 60 mg prasugrel
DRUG	Prasugrel	Patients who have not received a loading dose of clopidogrel will receive a 60 mg loading dose of prasugrel.

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2011-06-03
• Last updated: 2020-09-09

Locations

4 sites across 1 country: United States