Main-trial:Measuring the efficacy of once daily aspirin to inhibit platelet activity in patients during (recovery from) pneumonia or invasive urinary tract infection or cutaneous infection.Sub-study:To assess the influence of an infectious state on…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PFA-200 parameters: closure time, flow slope, maximum rate of occlusion and
area under the curve
TBX2 serum levels.
Secondary outcome
Platelet- , reticulated platelet- , leucocyte count and haemoglobin level as a
possible effect modifying parameter.
Background summary
Cardiovascular events can be triggered by a variety of common
non-cardiovascular clinical conditions, particularly those that are associated
with systemic inflammation. Although the pathogenesis has not yet been
clarified for 100%, hyperaggregability of thrombocytes seem to play a large
part in the increased cardiovascular risk. Therefore this study will
investigate the possibility of primary prevention by the use of aspirin in
these high-risk patients with pneumonia or invasive urinary tract infection or
cutaneous infection.Furthermore, we have added a sub-study, including patients
with stable cardiovascular disease, to investigate whether a severe infection
influence aspirin's efficacy to inhibit platelet activity in patients with know
cardiovasular disease.
Study objective
Main-trial:
Measuring the efficacy of once daily aspirin to inhibit platelet activity in
patients during (recovery from) pneumonia or invasive urinary tract infection
or cutaneous infection.
Sub-study:
To assess the influence of an infectious state on aspirin*s efficacy to inhibit
platelet activity in patients with stable cardiovascular disease.
Study design
An open label randomized study will be conducted to measure platelet activity
in patients during (recovery from) pneumonia or invasive urinary tract
infection of cutaneous infection and the efficacy aspirin to inhibit this
platelet activity. Patients from the Internal & Pulmonary medicine ward will be
screened for inclusion. Blood will be collected once dailty at fixed times at
8:00 AM. On three days : prior to randomization, on day 14 and > day 90.
Intervention
Main trial:
No treatment or 1dd 80mg aspirin. Repeated measurements of platelet function
testing via venapuncture.
Sub-study:
No intervention, purely observetional. Repeated measurements of platelet
function testing via venapuncture.
Study burden and risks
There is minimal risk in this trial. Patient in the intervention group could
benefit from the temporary protection of aspirin during a high risk period.
Thus enduring a lower risk of acute cardiovascular events after the recovery
from pneumonia or invasive urinary tract infection or cutaneous infection.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in the main-trial, a subject must meet
all of the following criteria:
Primary clinical diagnosis of pneumonia
OR
Primary clinical diagnosis of invasive urinary tract infection
OR
Primary clinical diagnosis of cutaneous infection
AND
18 years or older on the date of hospital presentation
AND
Hospitalization for at least 24 hours
AND
Having received at least 1 dose of antibiotics within 48 hours of admission.
In order to be eligible to participate in the sub-study, a subject must meet
all of the following criteria:
Primary clinical diagnosis of pneumonia
OR
Primary clinical diagnosis of invasive urinary tract infection
OR
Primary clinical diagnosis of cutaneous infection
AND
18 years or older on the date of hospital presentation
AND
Hospitalization for at least 24 hours
AND
Having received at least 1 dose of antibiotics within 48 hours of admission
AND
Known stable cardiovascular disease. Stable cardiovascular disease defined as:
coronary artery disease, peripheral vascular disease, or previous myocardial
infarction (>12 months).
AND
Chronic usage of 80 mg of non-enteric coated acetylsalicylic acid once daily in
the morning.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in the main-trial:
- Active metastatic cancer (c.q. malignancy)
- Allergy to salicylate
- Platelet count <120*109/l
- History of non-traumatic major bleeding
- Known bleeding diathesis
- Conditions which require antiplatelet therapy
- Usage of antiplatelet therapy
- Surgery 1 month prior to diagnosis
- Currently pregnant
- Chronic usage of medication which are known to influence platelet function
other than antibiotics (e.g. NSAID*s, tirofiban, eptifibatide, abciximab,
SSRI*s, clomipramine, amitriptyline, dipyridamole, verapamil, diltiazem ,
ginkgo biloba, ginseng, & St John*s wort)
A potential subject who meets any of the following criteria will be excluded
from participation in the sub-study:
- Active metastatic cancer (c.q. malignancy)
- Platelet count <120*109/l
- History of non-traumatic major bleeding
- Known bleeding diathesis
- Surgery 1 month prior to diagnosis
- Currently pregnant
- Chronic usage of medication which are known to influence platelet function
other than antibiotics or aspirin (e.g. NSAID*s, tirofiban, eptifibatide,
abciximab, SSRI*s, clomipramine, amitriptyline, dipyridamole, verapamil,
diltiazem , ginkgo biloba, ginseng, & St John*s wort)
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
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-004303-32-NL |
| CCMO | NL59727.029.16 |
| OMON | NL-OMON21579 |