The Effect of Reloading Prasugrel in a Patient Who Has Already Received a Loading Dose (LD) of Clopidogrel (SWITCH 600/60)
Primary Purpose
Acute Coronary Syndrome
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prasugrel
Prasugrel
Sponsored by

About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute Coronary Syndrome, Clopidogrel, Prasugrel
Eligibility Criteria
Inclusion Criteria:
- Patients age 18 or older, of both genders
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.
- An initial invasive strategy (e.g. early angiography) is planned.
- No contraindications to prasugrel therapy.
Exclusion Criteria:
- Known allergies to aspirin, clopidogrel, or prasugrel.
- Patient known to be pregnant or lactating.
- Patient with known history of bleeding diathesis, or currently active bleeding.
- Platelet count <100,000/mm3 at the time of enrollment.
- Hematocrit <25% at the time of enrollment.
- On warfarin therapy at the time of PCI, or patient likely to require warfarin therapy post-PCI.
- Received fibrinolytics within the past 48 hours.
- 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.
- Taking maintenance thienopyridine therapy in the previous 7 days.
- Known blood transfusion within the preceding 10 days.
- Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS) within the previous 5 days.
- Patients with known chronic liver disease.
- Age greater than 75 years.
- Body weight less than 60 kg.
- History of stroke or transient ischemic attack.
- Surgery planned within 1 month.
- Patient likely to require coronary artery bypass grafting.
- Any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.
Sites / Locations
- The Heart Center
- Washington Hospital Center
- Sinai Center for Thrombosis Research
- Saint Luke's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients who have received loading dose of clopidogrel
Patients who have not received loading dose of clopidogrel
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01365221
First Posted
May 11, 2011
Last Updated
September 4, 2020
Sponsor
Medstar Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01365221
Brief Title
The Effect of Reloading Prasugrel in a Patient Who Has Already Received a Loading Dose (LD) of Clopidogrel
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 2010 (Actual)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Acute Coronary Syndrome, Clopidogrel, Prasugrel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients who have received loading dose of clopidogrel
Arm Type
Experimental
Arm Title
Patients who have not received loading dose of clopidogrel
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Prasugrel
Intervention Description
Patients who have received 600 mg loading dose of clopidogrel will receive a reloading dose of 60 mg prasugrel
Intervention Type
Drug
Intervention Name(s)
Prasugrel
Intervention Description
Patients who have not received a loading dose of clopidogrel will receive a 60 mg loading dose of prasugrel.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients age 18 or older, of both genders
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.
An initial invasive strategy (e.g. early angiography) is planned.
No contraindications to prasugrel therapy.
Exclusion Criteria:
Known allergies to aspirin, clopidogrel, or prasugrel.
Patient known to be pregnant or lactating.
Patient with known history of bleeding diathesis, or currently active bleeding.
Platelet count <100,000/mm3 at the time of enrollment.
Hematocrit <25% at the time of enrollment.
On warfarin therapy at the time of PCI, or patient likely to require warfarin therapy post-PCI.
Received fibrinolytics within the past 48 hours.
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.
Taking maintenance thienopyridine therapy in the previous 7 days.
Known blood transfusion within the preceding 10 days.
Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS) within the previous 5 days.
Patients with known chronic liver disease.
Age greater than 75 years.
Body weight less than 60 kg.
History of stroke or transient ischemic attack.
Surgery planned within 1 month.
Patient likely to require coronary artery bypass grafting.
Any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Waksman, MD
Organizational Affiliation
Medstar Washington Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Heart Center
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Sinai Center for Thrombosis Research
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25041356
Citation
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.
Results Reference
result
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The Effect of Reloading Prasugrel in a Patient Who Has Already Received a Loading Dose (LD) of Clopidogrel
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