Ignite Creation Date:
2024-05-06 @ 7:54 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02628587
Status:
UNKNOWN
Last Update Posted:
2015-12-11
First Post:
2015-12-09
Brief Title:
Patent Versus Generic Clopidogrel in Acute Coronary Syndrome
Sponsor:
Hospital Central San Luis Potosi Mexico
Organization:
Hospital Central San Luis Potosi Mexico
Study Overview
Official Title:
Comparison of Platelet Reactivity in Patients With Acute Coronary Syndrome Given Patent Clopidogrel Versus Generic Clopidogrel Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2015-12
Last Known Status:
NOT_YET_RECRUITING
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:
Ischemic heart disease is the leading cause of death and disability in developed countries and is responsible for a third of deaths in persons over 35 years The most severe form of ischemic heart disease is sudden death and acute coronary syndrome ACS
There is evidence that early and optimal treatment of ACS decreases mortality Within the optimal treatment these patients must receive a reperfusion therapy as mechanical or pharmacologic treatment In addition to reperfusion treatment antiplatelet therapy is a central part of the management Aspirin plus a P2Y12 inhibitor have been shown to decrease mortality In our country clopidogrel is the more accessible and used P2Y12 inhibitor however it has been shown to have a wide variability in response and this variability could be influenced by different pharmacological genetic and environmental factors
Platelet reactivity measured by aggregometry predicts major cardiovascular events in ACS patients treated with clopidogrel Due to their frequent prescription generic clopidogrel efficacy must be evaluated The purpose of this study is to compare the platelet reactivity in patients with ACS receiving clopidogrel generic versus patent
There is evidence that early and optimal treatment of ACS decreases mortality Within the optimal treatment these patients must receive a reperfusion therapy as mechanical or pharmacologic treatment In addition to reperfusion treatment antiplatelet therapy is a central part of the management Aspirin plus a P2Y12 inhibitor have been shown to decrease mortality In our country clopidogrel is the more accessible and used P2Y12 inhibitor however it has been shown to have a wide variability in response and this variability could be influenced by different pharmacological genetic and environmental factors
Platelet reactivity measured by aggregometry predicts major cardiovascular events in ACS patients treated with clopidogrel Due to their frequent prescription generic clopidogrel efficacy must be evaluated The purpose of this study is to compare the platelet reactivity in patients with ACS receiving clopidogrel generic versus patent
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