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 Prasugrel and Ticagrelor .
Primary Purpose
Acute Coronary Syndrome, Non ST Elevation Myocardial Infarction, ST Elevation Myocardial Infarction
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Assessment of coronary flow reserve
Percutaneous Coronary Intervention
Ticagrelor loading
Prasugrel loading
Sponsored by
About this trial
This is an interventional basic science trial for Acute Coronary Syndrome
Eligibility Criteria
Inclusion Criteria:
• Patients with acute coronary syndrome undergoing Percutaneous Coronary Intervention with stent implantation;
- Patients ≥ 18 and ≤ 75 years old.
- Signed informed consent;
Exclusion Criteria:
• Patients with stable angina;
- prior myocardial infarction;
- prior revascularization (Percutaneous Coronary Intervention or coronary artery bypass grafting);
- Ticagrelor contraindications (history of intracranial hemorrhage, active pathological bleeding, severe hepatic impairment);
- Prasugrel contraindications (patients weighing less than 60 kg, patients who had previous stroke or transient ischemic attack, patients aged more than 75 years old);
- major periprocedural complications;
- suboptimal Percutaneous Coronary Intervention result (residual stenosis > 20%);
- glomerular filtration rate < 30 ml/min or requiring haemodialysis;
- Non-sinus rhythm;
- severe chronic obstructive pulmonary disease;
- requirement for oral anticoagulant;
- risk of bleeding or bradycardic events;
- ejection fraction < 45%;
- Cardiogenic shock;
- Severe left ventricular hypertrophy;
- severe valvular disease;
- diffuse coronary atherosclerosis;
Sites / Locations
- Massimo Mancone
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ticagrelor
Prasugrel
Arm Description
Patient randomized to Ticagrelor
Patient randomized to Prasugrel
Outcomes
Primary Outcome Measures
assessment of coronary flow reserve
Secondary Outcome Measures
Full Information
NCT ID
NCT02032303
First Posted
December 18, 2013
Last Updated
January 8, 2014
Sponsor
Azienda Policlinico Umberto I
1. Study Identification
Unique Protocol Identification Number
NCT02032303
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 Prasugrel and Ticagrelor .
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Policlinico Umberto I
4. Oversight
5. Study Description
Brief Summary
Study design 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 Prasugrel 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 1:1 ratio, to receive a loading dose of Ticagrelor (180 mg) or Prasugrel (60 mg). In patients with non-ST elevation myocardial infarction these drugs will be administered only when the coronary anatomy will be known, to avoid bleeding due to prasugrel, in patients suitable for coronary artery bypass grafting as recommended by European Society of Cardiology guidelines (Class IB) (10). In patients with ST elevation myocardial infarction, instead, prasugrel and ticagrelor will be administrated before the procedure, according to the European Society of Cardiology guidelines (Class IB) (11). 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 ug/Kg/min 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Non ST Elevation Myocardial Infarction, ST Elevation Myocardial Infarction, Unstable Angina
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ticagrelor
Arm Type
Active Comparator
Arm Description
Patient randomized to Ticagrelor
Arm Title
Prasugrel
Arm Type
Active Comparator
Arm Description
Patient randomized to Prasugrel
Intervention Type
Procedure
Intervention Name(s)
Assessment of coronary flow reserve
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention
Intervention Type
Drug
Intervention Name(s)
Ticagrelor loading
Intervention Type
Drug
Intervention Name(s)
Prasugrel loading
Primary Outcome Measure Information:
Title
assessment of coronary flow reserve
Time Frame
2 hours after the loading dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Patients with acute coronary syndrome undergoing Percutaneous Coronary Intervention with stent implantation;
Patients ≥ 18 and ≤ 75 years old.
Signed informed consent;
Exclusion Criteria:
• Patients with stable angina;
prior myocardial infarction;
prior revascularization (Percutaneous Coronary Intervention or coronary artery bypass grafting);
Ticagrelor contraindications (history of intracranial hemorrhage, active pathological bleeding, severe hepatic impairment);
Prasugrel contraindications (patients weighing less than 60 kg, patients who had previous stroke or transient ischemic attack, patients aged more than 75 years old);
major periprocedural complications;
suboptimal Percutaneous Coronary Intervention result (residual stenosis > 20%);
glomerular filtration rate < 30 ml/min or requiring haemodialysis;
Non-sinus rhythm;
severe chronic obstructive pulmonary disease;
requirement for oral anticoagulant;
risk of bleeding or bradycardic events;
ejection fraction < 45%;
Cardiogenic shock;
Severe left ventricular hypertrophy;
severe valvular disease;
diffuse coronary atherosclerosis;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
massimo mancone
Phone
00390649979044
Facility Information:
Facility Name
Massimo Mancone
City
Rome
ZIP/Postal Code
00100
Country
Italy
Facility Contact:
Phone
00390649970468
First Name & Middle Initial & Last Name & Degree
massimo mancone
12. IPD Sharing Statement
Learn more about this trial
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 Prasugrel and Ticagrelor .
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