Ignite Creation Date:
2024-05-06 @ 9:48 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03078257
Status:
UNKNOWN
Last Update Posted:
2017-03-13
First Post:
2017-02-23
Brief Title:
Different Platelet Activities Between Intracoronary and Peripheral Blood in Coronary Artery Disease Patients
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
Different Platelet Activities Between Intracoronary and Peripheral Blood in Coronary Artery Disease Patients
Status:
UNKNOWN
Status Verified Date:
2017-03
Last Known Status:
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:
DPABIAP
Brief Summary:
Antiplatelet treatment is important for coronary artery diseaseCAD patients Some patients are resistant to antiplatelet treatment based on platelet function testsPFTCurrently the results of PFT are mainly based on the analysis of peripheral blood instead adverse cardiovascular events in CAD patients may be more directly related to platelet activities in the coronary arteries Theres no evidence of system study to prove the PFT of peripheral blood can represent the platelet functions in coronary arteriesThe purpose of this study is to determine the different platelet activities in the blood of peripheral vein PV peripheral artery PA intracoronary artery IC in the CAD patients without or with different interventions
our study is divided into three parts Part A To study the different platelet activities in the blood of PV PA IC in the CAD patients with dual antiplatelet therapy
Part B To explore the different platelet activities of the above three sites in ST-segment elevation myocardial infarction STEMI patients who are administrated platelet membrane glycoprotein ⅡbⅢa GPⅡbⅢa receptor antagonist tirofiban in PV or IC and dual antiplatelet therapy
Part C To explore the different platelet activities of the above three sites in STEMI patients who are administrated antiplatelet thrombolysin or placebo in PV and dual antiplatelet therapy
our study is divided into three parts Part A To study the different platelet activities in the blood of PV PA IC in the CAD patients with dual antiplatelet therapy
Part B To explore the different platelet activities of the above three sites in ST-segment elevation myocardial infarction STEMI patients who are administrated platelet membrane glycoprotein ⅡbⅢa GPⅡbⅢa receptor antagonist tirofiban in PV or IC and dual antiplatelet therapy
Part C To explore the different platelet activities of the above three sites in STEMI patients who are administrated antiplatelet thrombolysin or placebo in PV and dual antiplatelet therapy
Detailed Description:
Part AA total of 30 CAD patients are recruitedAll patients are on loading dose of 300 mg clopidogrel followed by a maintenance dose of 75 mgd for at least 5 days and a loading dose of 300 mg aspirin followed by a maintenance dose of 100 mgd for at least 5 days All patients plan to receive coronary arteriography CAG or percutaneous coronary intervention PCIThe investigators sample blood from PVPA and IC before PCIRegional differences will be compared between blood samples from PVPA and IC by light aggregometry agonists arachidonic acid LTA-AA adenosine diphosphat LTA-ADP VerifyNow P2Y12 assays Differences between LTA and VerifyNow P2Y12-assay will also be compared
Part BA total of 30 STEMI patients are recruitedPatients are randomly assigned to 2 groupsA groupn15 is given tirofiban through PV the other groupn15 is given through ICAll patients are on loading dose of 600 mg clopidogrel and 300 mg aspirinAll patients plan to receive emergency PCI Group PV a loading dose of 10ugkg tirofiban is given in 3 min through PVfollowed by a maintenance dose of 015ugkgmin for 48hGroup IC a loading dose of 10ugkg tirofiban is given through ICfollowed by a maintenance dose of 015ugkgmin for 48h Blood samples are collceted from PV PA and IC before the injection of loading dose tirofiban and 15min after the injectionRegional differences will be compared between blood samples from PVPA and IC by LTA-AA LTA-ADP LTA-RISagonistsristocetinVerifyNow P2Y12 assays
Part CA total of 30 STEMI patients are recruitedPatients are randomly assigned to 2 groupsA groupn15 is given antiplatelet thrombolysinthe frist antiplatelet drugs based on GP Ib receptor which completed the preclinical and phase I clinical studiesand already has entered phase II clinical studies through PV the other groupn15 is given placebo through PVAll patients are on loading dose of 600 mg clopidogrel and 300 mg aspirinAll patients plan to receive emergency PCIBoth Groups are given in the same way a loading dose of 5 IU60kg in 5 min through PVfollowed by a maintenance dose of 0002 IUkgh for 48h Blood samples are collceted from PV PA and IC before the injection of loading dose of antiplatelet thrombolysin or placebo and 15 min after the injectionRegional differences will be compared between blood samples from PVPA and IC by LTA-AA LTA-ADP LTA-RIS and VerifyNow P2Y12 assays
Part BA total of 30 STEMI patients are recruitedPatients are randomly assigned to 2 groupsA groupn15 is given tirofiban through PV the other groupn15 is given through ICAll patients are on loading dose of 600 mg clopidogrel and 300 mg aspirinAll patients plan to receive emergency PCI Group PV a loading dose of 10ugkg tirofiban is given in 3 min through PVfollowed by a maintenance dose of 015ugkgmin for 48hGroup IC a loading dose of 10ugkg tirofiban is given through ICfollowed by a maintenance dose of 015ugkgmin for 48h Blood samples are collceted from PV PA and IC before the injection of loading dose tirofiban and 15min after the injectionRegional differences will be compared between blood samples from PVPA and IC by LTA-AA LTA-ADP LTA-RISagonistsristocetinVerifyNow P2Y12 assays
Part CA total of 30 STEMI patients are recruitedPatients are randomly assigned to 2 groupsA groupn15 is given antiplatelet thrombolysinthe frist antiplatelet drugs based on GP Ib receptor which completed the preclinical and phase I clinical studiesand already has entered phase II clinical studies through PV the other groupn15 is given placebo through PVAll patients are on loading dose of 600 mg clopidogrel and 300 mg aspirinAll patients plan to receive emergency PCIBoth Groups are given in the same way a loading dose of 5 IU60kg in 5 min through PVfollowed by a maintenance dose of 0002 IUkgh for 48h Blood samples are collceted from PV PA and IC before the injection of loading dose of antiplatelet thrombolysin or placebo and 15 min after the injectionRegional differences will be compared between blood samples from PVPA and IC by LTA-AA LTA-ADP LTA-RIS and VerifyNow P2Y12 assays
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