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

Acute Coronary Syndrome Clinical Trial

— SWITCH 600/60  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365221
• Other study ID #: SWITCH 600/60
• Status: Completed
• Phase: Phase 4
• Start date: October 2010
• Est. completion date: January 2014

Study information

• Verified date: September 2020
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 post-PCI.

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Drug:
• Prasugrel
Patients who have received 600 mg loading dose of clopidogrel will receive a reloading dose of 60 mg prasugrel
• Prasugrel
Patients who have not received a loading dose of clopidogrel will receive a 60 mg loading dose of prasugrel.

Locations

Country	Name	City	State
United States	Sinai Center for Thrombosis Research	Baltimore	Maryland
United States	The Heart Center	Huntsville	Alabama
United States	Saint Luke's Hospital	Kansas City	Missouri
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lhermusier T, Lipinski MJ, Drenning D, Marso S, Chen F, Torguson R, Waksman R. Switching patients from clopidogrel to prasugrel in acute coronary syndrome: impact of the clopidogrel loading dose on platelet reactivity. J Interv Cardiol. 2014 Aug;27(4):365 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Average hospital stay is 24-48 hours.
Secondary	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.		Average hospital stay is 24-48 hours.