HemostasisNCT00536068
Platelet Inhibition by Aspirin, Acetaminophen and NSAID
A study of Hemostasis, run by Kantonsspital Graubünden at 1 site in Switzerland.
Trial summary
Nonsteroidal antiinflammatory drugs such as diclofenac or naproxen may interfere with the inhibition of platelet aggregation by aspirin, because they all interact with the platelet cyclooxygenase.This may be of great clinical importance because of an increased cardiovascular event rate (myocardial infarction, stroke). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hemostasis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2006to Aug 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy volunteers
Who cannot join
- Administration of drugs affecting platelets
- History of bleeding
- Gastrointestinal disorders
- Hypersensitivity to aspirin and/or NSAID
- Pregnancy and breast feeding
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital Graubünden, Department of Internal Medicine
Chur, CH 7000
About this study
Nonsteroidal antiinflammatory drugs such as diclofenac or naproxen may interfere with the inhibition of platelet aggregation by aspirin, because they all interact with the platelet cyclooxygenase.This may be of great clinical importance because of an increased cardiovascular event rate (myocardial infarction, stroke). The present randomized, controlled study analyses in vitro platelet aggregation under a combined treatment of healthy volunteers with aspirin and either acetaminophen, diclofenac, naproxen, or placebo.
Read the detailed description
An in vivo study on healthy volunteers with combinations of well established drugs
- Conditions
- Hemostasis
- Being tested
- Acetylsalicylic acid, acetaminophen, diclofenac, naproxen, placebo
- Keywords
- platelet, aggregation, aspirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic acid, acetaminophen, diclofenac, naproxen, placeboDrug
- Acetylsalicylic acid 100mg/po and acetaminophen 3x1g/po for 4 days
- Acetylsalicylic acid 100mg/po and diclofenac 3x50mg/po for 4 days
- Acetylsalicylic acid 100mg/po and naproxen 3x250mg/po for 4 days
- Acetylsalicylic acid 100mg/po and placebo 3x1/po for 4 days
| Study group | Role | What they receive |
|---|---|---|
| 1, 2, 3, 4 | Experimental | 1. acetylsalicylic acid 100 mg/po,acetaminophen 3x1g/po
2. acetylsalicylic acid 100 mg/po,diclofenac 3x50mg/po
3. acetylsalicylic acid 100 mg/po,naproxen 3x250mg/po
4. acetylsalicylic acid 100 mg/po,placebo 3x1/po Receives: Drug: Acetylsalicylic acid, acetaminophen, diclofenac, naproxen, placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet aggregation
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2007 (estimated)
- Study startAug 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemostasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Graubünden
- Sponsor type
- University, hospital or other
- Investigators
- Walter H Reinhart, MD Professor, Principal investigator, Department of Internal Medicine, Kantonsspital Graubunden CH7000 Chur Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536068
- Sponsor's protocol ID
- KGWR0206
- Status last verified
- Sep 2007
- First submitted
- 26 Sep 2007
- Last updated
- 28 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Inhibition by Aspirin, Acetaminophen and NSAID
- ClinicalTrials.gov ID
- NCT00536068
- Acronym / sponsor ID
- KGWR0206
- Conditions
- Hemostasis
- Keywords
- platelet, aggregation, aspirin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Kantonsspital GraubündenUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- Aug 2007 (actual)
- First posted
- 27 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nonsteroidal antiinflammatory drugs such as diclofenac or naproxen may interfere with the inhibition of platelet aggregation by aspirin, because they all interact with the platelet cyclooxygenase.This may be of great clinical importance because of an increased cardiovascular event rate (myocardial infarction, stroke). The present randomized, controlled study analyses in vitro platelet aggregation under a combined treatment of healthy volunteers with aspirin and either acetaminophen, diclofenac, naproxen, or placebo.
Detailed description
An in vivo study on healthy volunteers with combinations of well established drugs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1, 2, 3, 4 | Experimental | Drug: Acetylsalicylic acid, acetaminophen, diclofenac, naproxen, placebo1. acetylsalicylic acid 100 mg/po,acetaminophen 3x1g/po 2. acetylsalicylic acid 100 mg/po,diclofenac 3x50mg/po 3. acetylsalicylic acid 100 mg/po,naproxen 3x250mg/po 4. acetylsalicylic acid 100 mg/po,placebo 3x1/po |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (5 listed)
- Administration of drugs affecting platelets
- History of bleeding
- Gastrointestinal disorders
- Hypersensitivity to aspirin and/or NSAID
- Pregnancy and breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylsalicylic acid, acetaminophen, diclofenac, naproxen, placebo1. Acetylsalicylic acid 100mg/po and acetaminophen 3x1g/po for 4 days 2. Acetylsalicylic acid 100mg/po and diclofenac 3x50mg/po for 4 days 3. Acetylsalicylic acid 100mg/po and naproxen 3x250mg/po for 4 days 4. Acetylsalicylic acid 100mg/po and placebo 3x1/po for 4 days | Drug | 1, 2, 3, 4 |
Primary outcome
platelet aggregation
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter H Reinhart, MD Professor principal investigator
Department of Internal Medicine, Kantonsspital Graubunden CH7000 Chur Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hemostasis, run by Kantonsspital Graubünden at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
platelet aggregation (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2007.