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Reversing Ticagrelor's Effects With Fresh Platelets

NCT02201394 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-12-05

Study results available
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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.

Conditions

Interventions

DRUG

Ticagrelor loading dose

Single loading dose of Ticagrelor 180 mg

DRUG

Aspirin loading dose

Single loading dose of Aspirin 325 mg

DRUG

Ticagrelor maintenance dose

Ticagrelor 90 mg twice daily x 7 days

DRUG

Aspirin maintenance dose

Aspirin 81 mg once daily x 7 days

Sponsors & Collaborators

Principal Investigators

  • Juan J Badimon, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02201394 on ClinicalTrials.gov