Status:
COMPLETED
Reversing Ticagrelor's Effects With Fresh Platelets
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
AstraZeneca
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Acute coronary syndrome (ACS) patients treated with antiplatelet drugs who require coronary artery bypass grafting (CABG) surgery have to wait 5-7 days for the effects of the drugs to wean off. This t...
Detailed Description
The current American College of Cardiology/American Heart Association (ACC/AHA) guidelines for ACS patients requiring CABG surgery after treatment with dual antiplatelet therapy recommend delaying sur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02201394
Start Date
July 1 2014
End Date
June 1 2016
Last Update
December 5 2017
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029