Research with human participants

Overview of medical research in the Netherlands

intra-individual platelet activation, as meased by PFA-200, at different time lapses after aspirin intake

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Last updated:

To eveluate the effect of amount of time past after last aspirin intake on platelet activability

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Other condition
Study type
Observational invasive

ID

NL-OMON39536

Source

ToetsingOnline

Brief title

Platelet activation in aspirin users, as measured by PFA-200

Condition

  • Other condition
  • Coagulopathies and bleeding diatheses (excl thrombocytopenic)

Synonym

Acute thromboembolic events

Health condition

Acute thrombo-embolische aandoeningen (cq. myocardinfarct, herseninfarct)

Research involving

Human

Sponsors and support

Primary sponsor :
Vrije Universiteit Medisch Centrum
Source(s) of monetary or material Support :
VUmc beheer B.V. 51072

Intervention

Keyword :
Aspirin, PFA-200, Platelet activation

Outcome measures

Primary outcome

platelet activability as measured by PFA-200

Secondary outcome

platelet count

platelet activability as measured by chronolog

hemoglobone

Background summary

In search of an explanation and possible solution for aspirin resistance we
postulate that when aspirin dosage interval is shortened, plateletactivability
is reduced.

Study objective

To eveluate the effect of amount of time past after last aspirin intake on
platelet activability

Study design

A cohort study, in which platelet activability, as measured by PFA-200 is
evaluated in consideration with time past after last aspirin intake

Study burden and risks

A total of 84 ml of blood is withdrawn in 4 indivual wihdrawals. The risk seems
marginal. There are no benefits for individual patients.

Public
Vrije Universiteit Medisch Centrum

De Boelelaan 1117
Amsterdam 1081 HV
NL
Scientific
Vrije Universiteit Medisch Centrum

De Boelelaan 1117
Amsterdam 1081 HV
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Outpatients from the cardiology and vascular surgery departments. Intake of respectively 100 mg or 80 mg of carbasalate calcium or acetylsalicylic acid once a day.

Exclusion criteria

* active bleeding
* thrombocytopenia
* thrombocytosis
* recent use of antiplatet drugs, anticoagulants or drugs that are known to alter platelelet function, other than aspirin (e.g. NSAID*s, tirofiban, eptifibatide, abciximab, beta-lactam antibiotics, dextran, SSRI*s, clomipramine & amitriptyline, dipyridamole, verapamil, diltiazem , ginkgo biloba, ginseng, St John*s wort)

Design

Study type :
Observational invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
30
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Amsterdam UMC
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Amsterdam UMC
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Amsterdam UMC

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
CCMO NL41763.029.12