Research with human participants

Overview of medical research in the Netherlands

The influence of omeprazole and pantoprazole on the platelet reactivity and inhibition of platelet aggregration of clopidogrel.

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To study the influence of omeprazole and pantoprazole on the platelet reactivity index and the inhibition of platelet aggregation by clopidogrel.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Coronary artery disorders
Study type
Interventional

ID

NL-OMON32694

Source

ToetsingOnline

Brief title

The influence of omeprazole and pantoprazole on the activity of clopidogrel

Condition

  • Coronary artery disorders
  • Gastrointestinal ulceration and perforation

Synonym

Activity of clopidogrel, prophylaxis against NSAID induced gastric damage

Research involving

Human

Sponsors and support

Primary sponsor :
Atrium Medisch Centrum
Source(s) of monetary or material Support :
Afdelingen Klinsche Farmacie en Klinische Chemie van het Atrium MC Parkstad.

Intervention

Keyword :
Clopidogrel, Omeprazole, Pantoprazole

Outcome measures

Primary outcome

1. The platelet reactivity index

2. The inhibition of platelet aggregation

Secondary outcome

Side effects of pantoprazole.

Background summary

Retrospective epidemiological studies showed a higher incidence of
cardiovascular events to be associated with the use of clopidogrel in
combination with omeprazole. This association is not found for pantoprazole.

Study objective

To study the influence of omeprazole and pantoprazole on the platelet
reactivity index and the inhibition of platelet aggregation by clopidogrel.

Study design

Single-center, open-label, cohort study.

Intervention

Replacing of omeprazole by pantoprazole for 4 weeks.

Study burden and risks

The risks are:
complications during the 2 venapunctions (visit 1: 15 ml blood, visit 2: 9 ml
blood).
Side effects of pantoprazole.

Public
Atrium Medisch Centrum

H. Dunantstraat 5
6419 PC Heerlen
Nederland
Scientific
Atrium Medisch Centrum

H. Dunantstraat 5
6419 PC Heerlen
Nederland

Listed location countries

Netherlands

Age

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

Inclusion criteria

1. Use of clopidogrel and aspirin or carbasalate calcium.
2. Use of omeprazole as prophylaxis against NSAID induced gastric damage.
3. Written informed consent.
4. 18 years or older.

Exclusion criteria

1. Use of medication which affects the metabolism of clopidogrel
2. Severe adverse reaction or hypersensitivity reaction to pantoprazole.
3. Gastrointesnital ulcer.
5. Renal impairment (creatinine> 200 mmol/l).
6. liver disease (AST, ALT, GGT> 3 x ULN).
7. Pregnancy

Design

Study phase :
4
Study type :
Interventional
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
27
Type :
Actual

Medical products/devices used

Product type :
Medicine
Brand name :
Pantozol
Generic name :
Pantoprazol
Registration
:
Yes - NL intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Z: Zuyderland-Zuyd (Heerlen)

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 EUCTR2009-016983-36-NL
CCMO NL30410.096.09