The aim of this study is to find out if a percutaneous angioplasty can be carried out safely in patients who received a therapeutic dose of Desirudin (Revasc®) before the operation.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this trial is to evaluate the change in ultrasensitive
troponin within 6-8 hours, 14-16 hours, and 22-24 hours following the index
procedure, as a surrogate marker for peri-procedural ischemic events.
Secondary outcome
The secondary objectives are to compare:
• the combined safety and the preliminary efficacy towards prevention of
ischemic events and major bleeding of two doses of Revasc® (Desirudin 30mg,
45mg), as compared to unfractionated heparin (UFH) and Bivalirudin, in addition
to a standard dual antiplatelet regimen, in the setting of elective low to
medium risk Percutaneous Coronary Intervention (PCI)
• the individual components of the primary endpoint, and of other major
clinical endpoints;
• the safety of the treatments plus dual antiplatelet therapy, particularly
with respect to bleeding complications;
• clinical signs of thrombosis;
• the coagulation profile of two different doses of Desirudin in addition to a
standard dual antiplatelet regimen in the setting of elective PCI.
• The differential effect of different anticoagulation regimens on neutrophil
activation, myeloperoxidase release and systemic inflammation following PCI.
Background summary
During percutaneous angioplasty, the blood vessel wall can become damaged. This
damage can give rise to formation of a blood plug or clot. A blood plug or clot
is caused by components in the blood such as thrombin and blood platelets. This
blood clot can disrupt the flow of blood in your coronary artery and can even
give rise to a complete blockage of the blood vessel, which will result in a
heart attack. In order to prevent this you will receive medicines (aspirin and
clopidogrel/plavix) which ensure that the effect of thrombin and blood
platelets is inhibited. In addition to this an anticoagulant such as heparin
shall be given during the procedure.
For more than 50 years heparin has been the most important medicine for
inhibiting thrombin. Despite its unmistakable advantages, this product also has
many shortcomings: finding the correct dose is often difficult, there is a risk
of antibodies being produced. Other new medicines with a similar effect are now
being developed.
Desirudin (Revasc®) is a new anticoagulant. Desirudin (Revasc®) is a medicine
which ensures that the effect of thrombin is inhibited. In clinical trials it
has been demonstrated that Desirudin (Revasc®) has a good anticoagulant effect
and it has proved successful in patients who had to undergo a hip or knee
operation.
Study objective
The aim of this study is to find out if a percutaneous angioplasty can be
carried out safely in patients who received a therapeutic dose of Desirudin
(Revasc®) before the operation.
Study design
The study is a randomized open label study. Participation in the study will
last for about 1 month.
In the week before the planned PCI procedure a screening visit will be done
during wghich the patient will be randomized to one of the four treatment
groups.
During the procedure until discharge coagulation parameters will be performed.
Thirty days after the procedure the patient will ne contacted by phone for
follow-up.
Intervention
Patients who participate in this study will receive 1 of the 4 treatment groups
administered before the PCI procedure.
Study burden and risks
Physical examination is done twice
Blood will be drawn 12 times, approximately 300 mls in total
Three ECgs will be recorded.
A pregnancy test will be done for women.
Executive Plaza One Suite 400
11350 McCormick Road, Hunt Valley, MD 21031
USA
Executive Plaza One Suite 400
11350 McCormick Road, Hunt Valley, MD 21031
USA
Listed location countries
Age
Inclusion criteria
The patient is at least 18 years old;
The patient is due to undergo an elective PCI on one or multiple lesions in the coronary vessel(s)
The patient provided written informed consent
Exclusion criteria
The patient is not a candidate for PCI
The patient experienced an acute Myocardial Infarction within previous 4 weeks.
The patient has an increased bleeding risk
Hemodynamic instability
Severe hypertension
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-010903-98-NL |
| CCMO | NL28449.078.09 |