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

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ClinicalTrials.gov Identifier: NCT01365221
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Rebecca Torguson, Medstar Health Research Institute

Tracking Information
First Submitted Date  ICMJE May 11, 2011
First Posted Date  ICMJE June 3, 2011
Last Update Posted Date January 2, 2020
Actual Study Start Date  ICMJE October 2010
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2011)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2011)
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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Reloading Prasugrel in a Patient Who Has Already Received a Loading Dose (LD) of Clopidogrel
Official Title  ICMJE SWITCH 600/60: The Effect of Reloading Prasugrel in a Patient Who Has Already Received a Loading Dose (LD) of Clopidogrel
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Coronary Syndrome
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * 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):365-72. doi: 10.1111/joic.12139. Epub 2014 Jul 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 27, 2019)
77
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2011)
260
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01365221
Other Study ID Numbers  ICMJE SWITCH 600/60
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rebecca Torguson, Medstar Health Research Institute
Study Sponsor  ICMJE Rebecca Torguson
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ron Waksman, MD Medstar Washington Hospital Center
PRS Account Medstar Health Research Institute
Verification Date December 2019

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