Ignite Creation Date:
2024-05-06 @ 3:08 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02215993
Status:
COMPLETED
Last Update Posted:
2017-05-23
First Post:
2014-06-03
Brief Title:
Sampling P2Y12 Receptor Inhibition With Prasugrel and Ticagrelor in Patients Submitted to Thrombolysis
Sponsor:
Federal University of São Paulo
Organization:
Federal University of São Paulo
Study Overview
Official Title:
Sampling P2Y12 Receptor Inhibition With Prasugrel and Ticagrelor in Patients Submitted to Thrombolysis After Loading Dose of Clopidogrel
Status:
COMPLETED
Status Verified Date:
2017-05
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:
SAMPA
Brief Summary:
Introduction
Platelet aggregation plays an important role in ischemic complications in patients undergoing to percutaneous coronary intervention PCI The addition of clopidogrel as a second antiplatelet agent to acetylsalicylic acid ASA was effective in reducing major cardiovascular events in patients with acute coronary syndrome ACS
However approximately 30 of ACS patients are resistant to clopidogrel representing a population of medically vulnerable and high risk for major cardiovascular events including myocardial infarction MI stent thrombosis and death
In the randomized trial TRITON prasugrel compared to clopidogrel was more effective in significantly reducing the rates of MI 74 vs 94 and stent thrombosis 24 vs 11 in patients with ACS however patients treated with prasugrel showed higher rates of bleeding 24 vs 18 and no difference in mortality Upon analysis of subgroups is not recommended its use in patients with a history of stroke in those older than 75 years and weighing less than 60 kg
The latest class of inhibitors of the P2Y12 receptor is the cyclopentyl-triazolopyrimidines represented by ticagrelor Unlike the thienopyridines ticagrelor interacts with the platelet receptors in a reversible way and has a beginning and peak of action faster
The efficacy and safety of ticagrelor were evaluated in the study PLATO where 18624 patients with ACS were randomized to receive clopidogrel 75mgday with a loading dose of 300 to 600mg or ticagrelor 90mg 2xday with a loading dose of 180mg The primary combined endpoint mortality from vascular causes MI or stroke at 12 months was significantly lower in the ticagrelor 98 vs 117 There was no significant difference in the rates of major bleeding in both groups Moreover the isolated analysis of the rates of MI vascular mortality and mortality from all causes showed statistically significant reduction in the ticagrelor users In this study the main adverse effects were dyspnea and bradycardia
The assessment of platelet reactivity may allow the individualization of antiplatelet therapy However simply increasing the dose of clopidogrel in patients who persisted with high platelet reactivity was not able to reduce the combined endpoint of cardiovascular death nonfatal myocardial infarction and stent thrombosis in six months
In a population of patients with stable coronary artery disease the substitution of clopidogrel for ticagrelor showed a rapid and persistent decrease in platelet aggregation measured by different laboratory methods However in patients with ACS subjected to PCI the assessment of platelet aggregation after the replacement of clopidogrel for prasugrel or ticagrelor still requires evidence
Objectives
To evaluate the platelet response to ticagrelor and prasugrel in ACS patients with ST-segment elevation submitted to thrombolysis
To evaluate security in follow up of 30 days
Methods
The study will be a prospective randomized single-center São Paulo Hospital - Federal University of São Paulo single-blind The investigators will select 50 patients admitted with ACS with ST-segment elevation submitted to thrombolysis and who underwent cardiac catheterization between 3 to 24 hours in the case of reperfusion or immediately for rescue angioplasty Blood sample for analysis of platelet aggregation through the system VerifyNow shall be obtained immediately after the procedure on patients on clopidogrel for at least seven days in maintenance dose of 75mg or after 8 to 6 hours after the dose of 300mg and 600mg respectively Patients will be randomized in a 11 ratio to receive ticagrelor the dose of 180mg and maintained dose of 90 mg twice a day for thirty days or prasugrel dose of 60mg and maintained for thirty days at a daily dose of 10mg A new blood sample and analysis of platelet aggregation will be repeated after 2 6 and 24 hours The demographic and clinical data of this population will be collected in specific form and stored in databases for later analysis
Platelet aggregation plays an important role in ischemic complications in patients undergoing to percutaneous coronary intervention PCI The addition of clopidogrel as a second antiplatelet agent to acetylsalicylic acid ASA was effective in reducing major cardiovascular events in patients with acute coronary syndrome ACS
However approximately 30 of ACS patients are resistant to clopidogrel representing a population of medically vulnerable and high risk for major cardiovascular events including myocardial infarction MI stent thrombosis and death
In the randomized trial TRITON prasugrel compared to clopidogrel was more effective in significantly reducing the rates of MI 74 vs 94 and stent thrombosis 24 vs 11 in patients with ACS however patients treated with prasugrel showed higher rates of bleeding 24 vs 18 and no difference in mortality Upon analysis of subgroups is not recommended its use in patients with a history of stroke in those older than 75 years and weighing less than 60 kg
The latest class of inhibitors of the P2Y12 receptor is the cyclopentyl-triazolopyrimidines represented by ticagrelor Unlike the thienopyridines ticagrelor interacts with the platelet receptors in a reversible way and has a beginning and peak of action faster
The efficacy and safety of ticagrelor were evaluated in the study PLATO where 18624 patients with ACS were randomized to receive clopidogrel 75mgday with a loading dose of 300 to 600mg or ticagrelor 90mg 2xday with a loading dose of 180mg The primary combined endpoint mortality from vascular causes MI or stroke at 12 months was significantly lower in the ticagrelor 98 vs 117 There was no significant difference in the rates of major bleeding in both groups Moreover the isolated analysis of the rates of MI vascular mortality and mortality from all causes showed statistically significant reduction in the ticagrelor users In this study the main adverse effects were dyspnea and bradycardia
The assessment of platelet reactivity may allow the individualization of antiplatelet therapy However simply increasing the dose of clopidogrel in patients who persisted with high platelet reactivity was not able to reduce the combined endpoint of cardiovascular death nonfatal myocardial infarction and stent thrombosis in six months
In a population of patients with stable coronary artery disease the substitution of clopidogrel for ticagrelor showed a rapid and persistent decrease in platelet aggregation measured by different laboratory methods However in patients with ACS subjected to PCI the assessment of platelet aggregation after the replacement of clopidogrel for prasugrel or ticagrelor still requires evidence
Objectives
To evaluate the platelet response to ticagrelor and prasugrel in ACS patients with ST-segment elevation submitted to thrombolysis
To evaluate security in follow up of 30 days
Methods
The study will be a prospective randomized single-center São Paulo Hospital - Federal University of São Paulo single-blind The investigators will select 50 patients admitted with ACS with ST-segment elevation submitted to thrombolysis and who underwent cardiac catheterization between 3 to 24 hours in the case of reperfusion or immediately for rescue angioplasty Blood sample for analysis of platelet aggregation through the system VerifyNow shall be obtained immediately after the procedure on patients on clopidogrel for at least seven days in maintenance dose of 75mg or after 8 to 6 hours after the dose of 300mg and 600mg respectively Patients will be randomized in a 11 ratio to receive ticagrelor the dose of 180mg and maintained dose of 90 mg twice a day for thirty days or prasugrel dose of 60mg and maintained for thirty days at a daily dose of 10mg A new blood sample and analysis of platelet aggregation will be repeated after 2 6 and 24 hours The demographic and clinical data of this population will be collected in specific form and stored in databases for later analysis
Detailed Description:
None
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