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

Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:18 - 75
Start Date:December 2010

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

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.

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.

Inclusion Criteria:

1. Patients age 18 or older, of both genders

2. 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.

3. An initial invasive strategy (e.g. early angiography) is planned.

4. No contraindications to prasugrel therapy.

Exclusion Criteria:

1. Known allergies to aspirin, clopidogrel, or prasugrel.

2. Patient known to be pregnant or lactating.

3. Patient with known history of bleeding diathesis, or currently active bleeding.

4. Platelet count <100,000/mm3 at the time of enrollment.

5. Hematocrit <25% at the time of enrollment.

6. On warfarin therapy at the time of PCI, or patient likely to require warfarin therapy

7. Received fibrinolytics within the past 48 hours.

8. 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.

9. Taking maintenance thienopyridine therapy in the previous 7 days.

10. Known blood transfusion within the preceding 10 days.

11. Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS) within the
previous 5 days.

12. Patients with known chronic liver disease.

13. Age greater than 75 years.

14. Body weight less than 60 kg.

15. History of stroke or transient ischemic attack.

16. Surgery planned within 1 month.

17. Patient likely to require coronary artery bypass grafting.

18. Any significant medical condition that, in the investigator's opinion, may interfere
with the patient's optimal participation in the study.
We found this trial at
232 S Woods Mill Rd
Chesterfield, Missouri 63017
(314) 205-6491
Saint Luke's Hospital St. Luke's Hospital, located in Chesterfield, Missouri, is a regional healthcare provider...
Chesterfield, MO
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Baltimore, Maryland 21215
Baltimore, MD
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Huntsville, Alabama 35801
Huntsville, AL
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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