Reversing Ticagrelor's Effects With Fresh Platelets

Description

ACS patients treated with antiplatelet drugs who require CABG surgery have to wait 5-7 days for the effects of the drugs to wean off. This treatment-devoid period leaves the patient vulnerable, therefore any means to shorten this period could be useful. The present study aims to investigate the possibility of reversing the antiplatelet effects of ticagrelor with the help of fresh donor platelets. Fresh platelets will be added to blood samples of treated patients in varying concentrations at specific timepoints to determine the time and amount of fresh platelets needed to normalize platelet reactivity in the treated samples.

Study Start Date

July 2014

Estimated Completion Date

June 2016

Interventions

  • Drug: Maintenance dose
  • Drug: Loading dose

Specialties

  • Cardiology: Coronary Artery Disease
  • Nursing: Cardiology
  • Pharmacy: Cardiac/Hypertension
  • Physician Assistant: Cardiology

MeSH Terms

  • Coronary Artery Disease
  • Myocardial Ischemia

Study ID

Mount Sinai School of Medicine -- GCO 13-1802

Status

Unknown

Trial ID

NCT02201394

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

40

Sponsor

Mount Sinai School of Medicine

Inclusion Criteria

  • Male or female volunteer between 18 and 75 years old.
  • History of stable (i.e. non-acute) cardiovascular disease or the presence of risk factors for cardiovascular disease (i.e. hypertension, diabetes, hyperlipidemia, high calcium score and abnormal findings on angiography or stress test).

Exclusion Criteria

  • Conditions associated with hemorrhagic risk, e.g., frequent epistaxis, gastrointestinal ulcer, hemorrhagic vascular lesions, recent surgery.
  • Allergy or hypersensitivity to aspirin or ticagrelor.
  • Loss of >400 mL blood or blood donation within past 3 months.
  • Positive serology for hepatitis B (HBs Ag) or hepatitis C.
  • History of drug abuse or alcohol abuse.
  • Positive pregnancy test.
  • Evidence of unstable or acute cardiovascular disease (e.g., unstable angina, recent myocardial infarction, congestive heart failure).
  • History of clinically relevant pulmonary, hepatic, gastrointestinal, renal, metabolic, hematologic, neurologic, respiratory or psychiatric disease, bleeding, acute infectious disease or signs of acute illness.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Icahn School of Medicine at Mount Sinai - New York, New York 46.8 miles None None None

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