Ignite Creation Date:
2024-05-06 @ 9:33 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03006835
Status:
UNKNOWN
Last Update Posted:
2016-12-30
First Post:
2016-12-27
Brief Title:
Different Dosage of Domestic and Imported Clopidogrel on the Platelet Inhibition Ratio in Patients Undergoing PCI
Sponsor:
Xijing Hospital
Organization:
Xijing Hospital
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2016-12
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:
This is a single-center randomized single-blind investigator-initiated pharmacological study with a parallel design Patients with non-ACS undergoing primary percutaneous coronary intervention will be randomized after informed consent in a 1111 ratio to the following treatment groups
Group Α Domestic Clopidogrel 300mg as a loading dose before PCI followed by 75mg per day
Group B Domestic Clopidogrel 600mg as a loading dose before PCI followed by 75mg per day
Group B Imported Clopidogrel 300mg as a loading dose before PCI followed by 75mg per day
Group D Imported Clopidogrel 600mg as a loading dose before PCI followed by 75mg per day
Platelet inhibition ratio assessment by thrombelastogram will be performed2 hours after the loading doseDay 0 6 hours after thrombelastogram Day 0 30 day after thrombelastogram Documentation of major adverse cardiac events death myocardial infarction stroke revascularization procedure with PCI or CABG and serious adverse events bleeding other adverse eventswill be performed until Day 30
Group Α Domestic Clopidogrel 300mg as a loading dose before PCI followed by 75mg per day
Group B Domestic Clopidogrel 600mg as a loading dose before PCI followed by 75mg per day
Group B Imported Clopidogrel 300mg as a loading dose before PCI followed by 75mg per day
Group D Imported Clopidogrel 600mg as a loading dose before PCI followed by 75mg per day
Platelet inhibition ratio assessment by thrombelastogram will be performed2 hours after the loading doseDay 0 6 hours after thrombelastogram Day 0 30 day after thrombelastogram Documentation of major adverse cardiac events death myocardial infarction stroke revascularization procedure with PCI or CABG and serious adverse events bleeding other adverse eventswill be performed until Day 30
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