Ignite Creation Date:
2024-05-06 @ 2:22 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02032290
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
2013-12-18
Brief Title:
Assessment of Coronary Flow Reserve by Doppler Flow Wire in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention Differences Between the Loading Dose of Ticagrelor and Clopidogrel
Sponsor:
Azienda Policlinico Umberto I
Organization:
Azienda Policlinico Umberto I
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2014-01
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:
The administration of these drugs is realized according to the European Society of Cardiology guidelines
All patients will be pretreated with aspirin 300 mg orally heparin iv to maintain an activated clotting time of 250 sec and a loading dose of ticagrelor 180 mg or clopidogrel 600 mg immediately before the revascularization The list of assignment to ticagrelor or clopidogrel will be generated by a computer according to a 11 randomization Primary Percutaneous Coronary Intervention will be performed according to standard clinical practice using femoral or radial artery Judkins approach via six or seven French heath insertion After crossing the target occlusive Lesion coronary stenting will be performed based on standard practice Patients subsequently will receive heparin for 48 hr aspirin 100 mg daily and clopidogrel 75 mgday or ticagrelor 90 mg twice daily for at least 12 months Other adjunctive pharmacotherapy in Intensive Care Unit will be administered according to operator discretion All patients will provide written informed consent before entering the study
Before and after the procedure a 12-leads ECG and an echocardiogram will be performed as standard practice Then all the pre- intra- and post-procedure data patients will be collected in a database
Investigators aim to perform a prospective single-center investigator-initiated randomized study to compare the Adenosine-induced coronary vasodilatation after the loading dose of Ticagrelor either Clopidogrel during the Percutaneous Coronary Intervention Patients with Acute Coronary Syndrome undergoing Percutaneous Coronary Intervention will be enrolled in the study and will be randomized in a 11 ratio to receive a loading dose of Ticagrelor 180 mg or Clopidogrel 600 mg Coronary Flow Reserve will be recorded by intracoronary Doppler Flow Wire before the stent implantation and after the procedure at baseline and 2-minute later adenosine intravenous administration at incremental doses of 50 80 110 and 140 ugKgmin with 2 minutes interval between infusions
Coronary Flow Reserve is the ability of the myocardium to increase blood flow in response to maximal exercise Doppler Flow Wire allows to measure this increase expressing it as a ratio between maximal vasodilation and flow at rest Coronary Flow Reserve is routinely measured in patients with Acute Coronary Syndrome without an increased risk of adverse events for patients neither adjunctive costs for the National Health System
Furthermore Plasma concentrations of Ticagrelor and its main metabolite AR-C124910XX will be measured in venous blood collected at the end of the procedure In patients requiring a second Percutaneous Coronary Intervention for example for multivessel disease all these measures will be repeated in the same manner
All patients will be pretreated with aspirin 300 mg orally heparin iv to maintain an activated clotting time of 250 sec and a loading dose of ticagrelor 180 mg or clopidogrel 600 mg immediately before the revascularization The list of assignment to ticagrelor or clopidogrel will be generated by a computer according to a 11 randomization Primary Percutaneous Coronary Intervention will be performed according to standard clinical practice using femoral or radial artery Judkins approach via six or seven French heath insertion After crossing the target occlusive Lesion coronary stenting will be performed based on standard practice Patients subsequently will receive heparin for 48 hr aspirin 100 mg daily and clopidogrel 75 mgday or ticagrelor 90 mg twice daily for at least 12 months Other adjunctive pharmacotherapy in Intensive Care Unit will be administered according to operator discretion All patients will provide written informed consent before entering the study
Before and after the procedure a 12-leads ECG and an echocardiogram will be performed as standard practice Then all the pre- intra- and post-procedure data patients will be collected in a database
Investigators aim to perform a prospective single-center investigator-initiated randomized study to compare the Adenosine-induced coronary vasodilatation after the loading dose of Ticagrelor either Clopidogrel during the Percutaneous Coronary Intervention Patients with Acute Coronary Syndrome undergoing Percutaneous Coronary Intervention will be enrolled in the study and will be randomized in a 11 ratio to receive a loading dose of Ticagrelor 180 mg or Clopidogrel 600 mg Coronary Flow Reserve will be recorded by intracoronary Doppler Flow Wire before the stent implantation and after the procedure at baseline and 2-minute later adenosine intravenous administration at incremental doses of 50 80 110 and 140 ugKgmin with 2 minutes interval between infusions
Coronary Flow Reserve is the ability of the myocardium to increase blood flow in response to maximal exercise Doppler Flow Wire allows to measure this increase expressing it as a ratio between maximal vasodilation and flow at rest Coronary Flow Reserve is routinely measured in patients with Acute Coronary Syndrome without an increased risk of adverse events for patients neither adjunctive costs for the National Health System
Furthermore Plasma concentrations of Ticagrelor and its main metabolite AR-C124910XX will be measured in venous blood collected at the end of the procedure In patients requiring a second Percutaneous Coronary Intervention for example for multivessel disease all these measures will be repeated in the same manner
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