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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)

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
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Drug: Prasugrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: SWITCH 600/60: The Effect of Reloading Prasugrel in a Patient Who Has Already Received a Loading Dose (LD) of Clopidogrel

Resource links provided by NLM:


Further study details as provided by Medstar Research Institute:

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. [ Time Frame: Average hospital stay is 24-48 hours. ] [ Designated as safety issue: Yes ]

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. [ Time Frame: Average hospital stay is 24-48 hours. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 260
Study Start Date: December 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients who have received loading dose of clopidogrel Drug: Prasugrel
Patients who have received 600 mg loading dose of clopidogrel will receive a reloading dose of 60 mg prasugrel
Active Comparator: Patients who have not received loading dose of clopidogrel Drug: Prasugrel
Patients who have not received a loading dose of clopidogrel will receive a 60 mg 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365221

Locations
United States, Alabama
The Heart Center
Huntsville, Alabama, United States, 35801
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Maryland
Sinai Center for Thrombosis Research
Baltimore, Maryland, United States, 21215
United States, Missouri
Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
Medstar Research Institute
Investigators
Principal Investigator: Ron Waksman, MD Medstar Washington Hospital Center
  More Information

No publications provided

Responsible Party: Medstar Research Institute
ClinicalTrials.gov Identifier: NCT01365221     History of Changes
Other Study ID Numbers: SWITCH 600/60
Study First Received: May 11, 2011
Last Updated: October 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medstar Research Institute:
Acute Coronary Syndrome
Clopidogrel
Prasugrel

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Clopidogrel
Prasugrel
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014