Phase 4
N=20
Reversing Ticagrelor's Effects With Fresh Platelets
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT02201394 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: P2Y12 Reaction Unit (PRU) — 284.1; 284.1; 39.1; 37.5 PRU
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ticagrelor loading dose (Drug); Aspirin loading dose (Drug); Ticagrelor maintenance dose (Drug); Aspirin maintenance dose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY P2Y12 Reaction Unit (PRU) |
284.1; 284.1; 39.1; 37.5; 69.6; 72.2 | — |
| PRIMARY Platelet Aggregation Using Multiplate Analyzer |
67.0; 67.0; 13.6; 15.7; 18.7; 20.9 | — |
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 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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02201394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.