Differential Effect of Ticagrelor Versus Prasugrel Maintenance Dose on Endothelial Function of Peripheral Vessels in Patients With Coronary Artery Disease
Primary Purpose
Coronary Artery Disease, Endothelial Function
Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Ticagrelor
Prasugrel
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring ticagrelor, prasugrel, endothelial function
Eligibility Criteria
Inclusion Criteria:
- Age 18-74 years old
- Patients with stable CAD who have been submitted(?) to percutaneous intervention for Acute Coronary Syndrome and receiving prasugrel MD 10mg once a day for at least the previous 3 months.
- Patients giving written Informed Consent.
Exclusion Criteria:
- Acute Coronary Syndrome
Contraindication for administration of prasugrel or ticagrelor
- Known hypersensitivity to clopidogrel or ticagrelor
- Active bleeding (peptic ulcer, intracranial bleeding)
- Severe liver impairment
- Any previous history of intracranial bleeding or transient ischemic attack or ischemic cerebrovascular event
- Treatment with potent CYP3A4 inhibitors (ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir)
- Requirement for oral anticoagulant agents prior to the day 30 visit
- History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months
- Increased risk for bradyarrhythmias, according to the investigator's evaluation
- Severe non-controlled chronic obstructive pulmonary disease
- Creatinine clearance <30ml/min/1.73mm2
- HbA1c > 10mg/dl
Sites / Locations
- Patras University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ticagrelor
Prasugrel
Arm Description
Ticagrelor 90mg bid for 15 days
Prasugrel 10mg od for 15 days
Outcomes
Primary Outcome Measures
Reactive Hyperemia Index (RHI) in the 2 subgroups at the end of 2 periods of treatment
Secondary Outcome Measures
Percentage of patients with endothelial dysfunction (RHI<1.67) at the end of 2 periods of treatment
Full Information
NCT ID
NCT01957540
First Posted
September 30, 2013
Last Updated
January 8, 2017
Sponsor
University of Patras
1. Study Identification
Unique Protocol Identification Number
NCT01957540
Brief Title
Differential Effect of Ticagrelor Versus Prasugrel Maintenance Dose on Endothelial Function of Peripheral Vessels in Patients With Coronary Artery Disease
Official Title
Differential Effect of Ticagrelor Versus Prasugrel Maintenance Dose on Endothelial Function of Peripheral Vessels in Patients With Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Patras
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Ticagrelor administration, whose molecule resembles to adenosine, led to reduction in overall mortality and thrombotic cardiovascular (CV) events when directly compared to clopidogrel in the PLATO trial, implicating possible pleiotropic actions for the drug. It has been shown that ticagrelor increases adenosine concentration, by interfering with its red blood cells' uptake and by inducing the release of ATP which is then converted to adenosine. Recent studies in healthy volunteers and patients with coronary artery disease (CAD) have shown that ticagrelor increases the coronary blood flow in response to intravenous adenosine administration. Ticagrelor administration, in comparison with other P2Y12 inhibitors, may influence the endothelial function, as assessed by the Peripheral Arterial Tonometry method (EndoPAT 2000 system (Itamar Medical, Caesarea, Israel), which is a method for evaluating endothelial dysfunction and has been found to positively correlate with flow mediated dilatation (FMD).
This is prospective, randomized study with a crossover design, which will be conducted in patients with CAD under prasugrel maintenance dose (MD) 10mg once a day for at least a 3-month period. At Day 0 (day of randomization) eligible patients will be assigned to either:
Ticagrelor 90mg twice a day for the next 15 days or
Prasugrel 10mg once a day for the next 15 days At Day 0 (before treatment onset)patients wiil be subjected to a baseline peripheral arterial tonometry measurement. Measurement will be repeated at Day 15 and then treatment crossover will be performed for the next 15 days (without an intervening washout period). At Day 30 patients will be subjected again to peripheral arterial tonometry assessment. Peripheral blood sample will be taken from the patients in Day 0 for genotyping control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Endothelial Function
Keywords
ticagrelor, prasugrel, endothelial function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ticagrelor
Arm Type
Experimental
Arm Description
Ticagrelor 90mg bid for 15 days
Arm Title
Prasugrel
Arm Type
Active Comparator
Arm Description
Prasugrel 10mg od for 15 days
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Type
Drug
Intervention Name(s)
Prasugrel
Primary Outcome Measure Information:
Title
Reactive Hyperemia Index (RHI) in the 2 subgroups at the end of 2 periods of treatment
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Percentage of patients with endothelial dysfunction (RHI<1.67) at the end of 2 periods of treatment
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-74 years old
Patients with stable CAD who have been submitted(?) to percutaneous intervention for Acute Coronary Syndrome and receiving prasugrel MD 10mg once a day for at least the previous 3 months.
Patients giving written Informed Consent.
Exclusion Criteria:
Acute Coronary Syndrome
Contraindication for administration of prasugrel or ticagrelor
Known hypersensitivity to clopidogrel or ticagrelor
Active bleeding (peptic ulcer, intracranial bleeding)
Severe liver impairment
Any previous history of intracranial bleeding or transient ischemic attack or ischemic cerebrovascular event
Treatment with potent CYP3A4 inhibitors (ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir)
Requirement for oral anticoagulant agents prior to the day 30 visit
History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months
Increased risk for bradyarrhythmias, according to the investigator's evaluation
Severe non-controlled chronic obstructive pulmonary disease
Creatinine clearance <30ml/min/1.73mm2
HbA1c > 10mg/dl
Facility Information:
Facility Name
Patras University Hospital
City
Patras
State/Province
Achaia
ZIP/Postal Code
26500
Country
Greece
12. IPD Sharing Statement
Citations:
PubMed Identifier
29292242
Citation
Xanthopoulou I, Bei I, Bampouri T, Barampoutis N, Moulias A, Davlouros P, Alexopoulos D. Absence of differential effect of ticagrelor versus prasugrel maintenance dose on endothelial function in patients with stable coronary artery disease. Hellenic J Cardiol. 2018 Nov-Dec;59(6):338-343. doi: 10.1016/j.hjc.2017.12.008. Epub 2017 Dec 29.
Results Reference
derived
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Differential Effect of Ticagrelor Versus Prasugrel Maintenance Dose on Endothelial Function of Peripheral Vessels in Patients With Coronary Artery Disease
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