Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02261922 |
| Other study ID # |
FM240 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 4
|
| First received |
October 7, 2014 |
| Last updated |
October 9, 2014 |
| Start date |
October 2014 |
| Est. completion date |
November 2015 |
Study information
| Verified date |
October 2014 |
| Source |
Hotel Dieu de France Hospital |
| Contact |
Rabih Azar, MD, MPH |
| Email |
razar[@]usj.edu.lb |
| Is FDA regulated |
No |
| Health authority |
Lebanon: Ministry of Public Health |
| Study type |
Interventional
|
Clinical Trial Summary
To evaluate the effect of ticagrelor on endothelial function as measured by flow mediated
dilation of the brachial artery. This will be compared to prasugrel.
Description:
Objective:
Demonstrate an improvement in endothelial function with ticagrelor
Introduction and hypothesis:
Ticagrelor and prasugrel are 2 new platelet antagonists. Both are superior to clopidogrel
when used in acute coronary syndromes. However, only ticagrelor reduced cardiovascular
mortality by almost 20%. Prasugrel reduced the composite clinical end point of
cardiovascular mortality, myocardial infarction and stroke, but did not decrease mortality.
The exact mechanism of mortality reduction with ticagrelor is unclear.
Some side effects of ticagrelor, such as brady-arrhythmias and dyspnea may be related to
adenosine release. It is thus possible, that this drug may liberate significant amount of
adenosine. Prior studies have demonstrated that adenosine has beneficial effects on the
endothelial function and that it improves the outcome of patient with acute coronary
syndromes.
It is thus possible that ticagrelor may improve endothelial function through an adenosine
like effect. This effect is independent from platelet inhibition.
Prasugrel has the same platelet inhibition effect compared to ticagrelor, but our hypothesis
is that it does not have an adenosine like effect and thus does not improve endothelial
function.
Study design:
This is a prospective, randomized, double blind, cross-over study comparing 2 new platelet
inhibitors that have the same potency: ticagrelor and prasugrel.
Patients with stable coronary artery disease will be randomized to one of these 2 drugs.
Patients will receive one of the 2 drugs for a period of 8 +/- 2 days, they will then stop
the drug for a period of 14 +/- 2 days, and they will then cross over and receive the other
drug for a period of 8 +/- 2 days.
All patients will have the following measurements:
- Flow mediated Dilation (FMD) of the brachial artery
- Platelet aggregation in response to ADP
All measurements will be done at:
- Baseline 1 (prior to starting drug 1)
- At 8 +/- 2 days (peak effect of drug 1)
- Baseline 2 (at 14+/- 2 days; after washout and prior to starting drug 2)
- At 8 +/- 2 days after baseline 2 (peak effect of drug 2)
Measure of FMD of the brachial artery:
It will be performed according to the Academic Medical Center of Amsterdam pre-established
protocol.
Measure of platelet aggregation:
It will be performed with the multiplate aggregometer
Study End-Points:
- Primary: change in FMD before and after each of the 2 drugs
- Secondary: Change in platelet aggregation before and after each of the 2 drugs
- Possible another secondary end-point: Change in NO activity in the blood before and
after each of the 2 drugs
