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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01365221
First received: May 11, 2011
Last updated: October 31, 2013
Last verified: October 2013

May 11, 2011
October 31, 2013
December 2010
January 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01365221 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Coronary Syndrome
  • 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.
  • Experimental: Patients who have received loading dose of clopidogrel
    Intervention: Drug: Prasugrel
  • Active Comparator: Patients who have not received loading dose of clopidogrel
    Intervention: Drug: Prasugrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
260
January 2014
January 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01365221
SWITCH 600/60
No
Medstar Research Institute
Medstar Research Institute
Not Provided
Principal Investigator: Ron Waksman, MD Medstar Washington Hospital Center
Medstar Research Institute
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP