Reversing Ticagrelor's Effects With Fresh Platelets
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|ClinicalTrials.gov Identifier: NCT02201394|
Recruitment Status : Completed
First Posted : July 28, 2014
Results First Posted : December 5, 2017
Last Update Posted : December 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Ticagrelor loading dose Drug: Aspirin loading dose Drug: Ticagrelor maintenance dose Drug: Aspirin maintenance dose||Phase 4|
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 surgery for 5-7 days after discontinuation of therapy, to allow for the dissipation of its antiplatelet effects. This treatment-devoid waiting period puts the ACS patients at risk for further cardiovascular events. Any means to shorten this vulnerable period would be of critical value. One possibility to speed up the recovery of the inhibited platelets is to administer infusions of fresh platelets. In fact, platelet transfusions are frequently administered to patients during surgery who had received prior antiplatelet therapy. However, the degree to which these transfusions restore platelet function in the recipient subjects' blood and the time from dosing when they are most effective are unknown. The timing is critical in scenarios where urgent surgery is required because infusion of platelets too soon after antiplatelet dosing could render them useless by the residual drug in circulation.
The aim of the present study is to investigate the restoration of platelet function of ticagrelor-treated subjects by adding donor platelets to their blood. The study would have 2 arms mimicking different clinical scenarios:
- Clinical Scenario 1 - Patient given a loading dose (LD) of ticagrelor in the emergency room, requires surgery: A single LD of ticagrelor (180 mg) with aspirin (325 mg) will be given to study subjects and platelet testing will be performed after addition of fresh platelets to their blood ex vivo. Donor platelets will be added at 4-, 6-, 24- and 48-hours post-dose, to assess the time required for normalizing subject's platelet function after a LD of ticagrelor.
- Clinical Scenario 2 - Patient on maintenance dosing (MD) of ticagrelor, requires surgery: Subjects will receive ticagrelor (90 mg twice daily) with aspirin (81 mg once daily) for 3-7 days. After the last dose, platelet testing will be performed after addition of fresh platelets to their blood ex vivo, at 4-, 6-, 24- and 48-hours post-dose to assess the time required for normalizing subject's platelet function after daily treatment with ticagrelor.
Platelet testing will be carried out using the following methodologies:
- Platelet Aggregation - VerifyNow P2Y12 assay.
- Platelet Aggregation - Multiplate Analyzer.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Normalizing Platelet Reactivity After Treatment With Ticagrelor|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Loading dose
Patients with stable CVD given a single ticagrelor loading dose and aspirin loading dose
Drug: Ticagrelor loading dose
Single loading dose of Ticagrelor 180 mg
Other Name: Brilinta
Drug: Aspirin loading dose
Single loading dose of Aspirin 325 mg
Experimental: Maintenance dose
Patients with stable CVD given ticagrelor maintenance dose and aspirin maintenance dose for one week.
Drug: Ticagrelor maintenance dose
Ticagrelor 90 mg twice daily x 7 days
Drug: Aspirin maintenance dose
Aspirin 81 mg once daily x 7 days
- P2Y12 Reaction Unit (PRU) [ Time Frame: Baseline (pre-treatment), 4, 6, 24 and 48 hours post Loading dose/last Maintenance dose ]Platelet function normalization using different concentrations (0%, 25%, 50%, and 75% supplementations) of fresh platelet within 48 hours of Ticagrelor Loading dose/last Maintenance dose, assessed using VerifyNow and expressed as P2Y12 Reaction Unit (PRU). The P2Y12 reaction unit (PRU) is an arbitrary unit of measure that represents the amount of platelet aggregation specific to the P2Y12 receptor.
- Platelet Aggregation Using Multiplate Analyzer [ Time Frame: Baseline (pre-treatment), 4, 6, 24, and 48 hours post Loading dose/last Maintenance dose ]Platelet function normalization using different concentrations of fresh platelet within 48 hours of Ticagrelor Loading dose/last Maintenance dose, assessed using Multiplate Aggregometry (ADPtest), results expressed as Area Under Curve (U), where 1 U = 10 AU * min.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02201394
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Juan J Badimon, PhD||Icahn School of Medicine at Mount Sinai|