Ignite Creation Date:
2024-05-06 @ 3:06 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02201394
Status:
COMPLETED
Last Update Posted:
2017-12-05
First Post:
2014-07-24
Brief Title:
Reversing Ticagrelors Effects With Fresh Platelets
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Normalizing Platelet Reactivity After Treatment With Ticagrelor
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
Detailed Description:
The current American College of CardiologyAmerican Heart Association ACCAHA 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
1 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 subjects platelet function after a LD of ticagrelor
2 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 subjects platelet function after daily treatment with ticagrelor
Platelet testing will be carried out using the following methodologies
1 Platelet Aggregation - VerifyNow P2Y12 assay
2 Platelet Aggregation - Multiplate Analyzer
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
1 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 subjects platelet function after a LD of ticagrelor
2 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 subjects platelet function after daily treatment with ticagrelor
Platelet testing will be carried out using the following methodologies
1 Platelet Aggregation - VerifyNow P2Y12 assay
2 Platelet Aggregation - Multiplate Analyzer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None