Healthy VolunteersPhase 1NCT01108588
Reproducibility and Comparison of Platelet Function Assays With Aspirin and Clopidogrel (MK-0000-167)
A Phase 1 study testing Aspirin and Clopidogrel in people with Healthy Volunteers, run by Merck Sharp & Dohme LLC.
Trial summary
This study will evaluate whether the antiplatelet effects of Aspirin 300 mg daily and Clopidogrel 75 mg daily can be reproducibly measured using several point of care platelet function assays Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Aspirin and Clopidogrel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Aug 2010
- Phase
- Phase 1
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject has BMI (Body Mass Index) less than 32 kg/m^ 2
- Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 3 months
- Subject does not have a history of any bleeding disorder
Who cannot join
- Subject is a pregnant or nursing female
- Subject has a history of multiple and/or severe allergies to drugs or foods, or any history (personal or family) of bleeding disorders (including arterial bleeding, hemorrhage requiring transfusion or urgent intervention)
- Subject currently uses on a regular basis or has used aspirin or clopidogrel within 21 days prior to screening (including low-dose aspirin and pain relievers, cold, or sinus remedies containing aspirin)
- Subject currently uses on a regular basis or has used within 2 weeks prior to study start, any other prescription or nonprescription drugs, including NSAIDs such as ibuprofen, naproxen, COX-II inhibitors such as celecoxib or etoricoxib, other pain relievers, cold, or sinus remedies containing NSAIDs, and herbal remedies (e.g., St. John Wort)
- Subject anticipates needing during the study any prescription or nonprescription (including over the counter) preparation, including those that contain aspirin, ibuprofen, or any other NSAID or NSAID-containing product commonly found in pain relievers, cold or sinus remedies
- Subject has a history of skin conditions (such as dry skin, pruritus, rosacea, eczema) or has a sun burn at the time of screening and is unwilling to avoid excessive sun exposure for the duration of the study
- Subject regularly uses antacids or other OTC medications (4 or more times per month) for symptoms of dyspepsia or has a history of use of prescription ulcer medication such as H2 blockers (e.g., cimetidine, ranitidine, famotidine, nizatidine) or a proton pump inhibitor (omeprazole) within the last 5 years
- Subject has a history of poor wound healing or a tendency to form keloids
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Cross-over Study Using Aspirin and Clopidogrel to Assess Reproducibility and Compare Platelet Function Assays
This study will evaluate whether the antiplatelet effects of Aspirin 300 mg daily and Clopidogrel 75 mg daily can be reproducibly measured using several point of care platelet function assays
- Conditions
- Healthy Volunteers
- Being tested
- Placebo (to match Aspirin), Aspirin, Clopidogrel, Comparator: Placebo (to match Clopidogrel)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (to match Aspirin)Drug
Placebo grossly matched Aspirin 300 mg daily
AspirinDrug
Aspirin 300 mg daily
ClopidogrelDrug
Clopidogrel 75 mg daily
Comparator: Placebo (to match Clopidogrel)Drug
Placebo (grossly matched Clopidogrel 75 mg) daily
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Aspirin - Clopidogrel - Placebo Receives: Drug: Placebo (to match Aspirin); Drug: Aspirin; Drug: Clopidogrel; Drug: Comparator: Placebo (to match Clopidogrel) |
| Sequence 2 | Experimental | Clopidogrel - Placebo - Aspirin Receives: Drug: Placebo (to match Aspirin); Drug: Aspirin; Drug: Clopidogrel; Drug: Comparator: Placebo (to match Clopidogrel) |
| Sequence 3 | Experimental | Placebo - Aspirin - Clopidogrel Receives: Drug: Placebo (to match Aspirin); Drug: Aspirin; Drug: Clopidogrel; Drug: Comparator: Placebo (to match Clopidogrel) |
| Sequence 4 | Experimental | Aspirin - Placebo - Clopidogrel Receives: Drug: Placebo (to match Aspirin); Drug: Aspirin; Drug: Clopidogrel; Drug: Comparator: Placebo (to match Clopidogrel) |
| Sequence 5 | Experimental | Clopidogrel - Aspirin - Placebo Receives: Drug: Placebo (to match Aspirin); Drug: Aspirin; Drug: Clopidogrel; Drug: Comparator: Placebo (to match Clopidogrel) |
| Sequence 6 | Experimental | Placebo - Clopidogrel - Aspirin Receives: Drug: Placebo (to match Aspirin); Drug: Aspirin; Drug: Clopidogrel; Drug: Comparator: Placebo (to match Clopidogrel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect size of light transmission platelet aggregation, bleeding time, and several point of care platelet function assays after 3 days of administration of study drug compared to placebo treatment.
Measured: Baseline and 3 days
The intra-subject coefficient of variation of each of the 3 platelet function devices
Measured: Baseline and 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108588
- Sponsor's protocol ID
- 0000-167
- Other IDs
- 167
- Status last verified
- Aug 2015
- First submitted
- 20 Apr 2010
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Chen F, Maridakis V, O'neill EA, Beals C, Radziszewski W, de Lepeleire I, Van Dyck K, Depre M, Bolognese JA, de Hoon J, Jacquemin M. A randomized clinical trial comparing point-of-care platelet function assays and bleeding time in healthy subjects treated with aspirin or clopidogrel. Platelets. 2012;23(4):249-58. doi: 10.3109/09537104.2011.604806. Epub 2011 Sep 15.
PubMed 21919555
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Cross-over Study Using Aspirin and Clopidogrel to Assess Reproducibility and Compare Platelet Function Assays
- ClinicalTrials.gov ID
- NCT01108588
- Acronym / sponsor ID
- 0000-167
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 22 Apr 2010 (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.
This study will evaluate whether the antiplatelet effects of Aspirin 300 mg daily and Clopidogrel 75 mg daily can be reproducibly measured using several point of care platelet function assays
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Placebo (to match Aspirin), Drug: Aspirin, Drug: Clopidogrel, Drug: Comparator: Placebo (to match Clopidogrel)Aspirin - Clopidogrel - Placebo |
| Sequence 2 | Experimental | Drug: Placebo (to match Aspirin), Drug: Aspirin, Drug: Clopidogrel, Drug: Comparator: Placebo (to match Clopidogrel)Clopidogrel - Placebo - Aspirin |
| Sequence 3 | Experimental | Drug: Placebo (to match Aspirin), Drug: Aspirin, Drug: Clopidogrel, Drug: Comparator: Placebo (to match Clopidogrel)Placebo - Aspirin - Clopidogrel |
| Sequence 4 | Experimental | Drug: Placebo (to match Aspirin), Drug: Aspirin, Drug: Clopidogrel, Drug: Comparator: Placebo (to match Clopidogrel)Aspirin - Placebo - Clopidogrel |
| Sequence 5 | Experimental | Drug: Placebo (to match Aspirin), Drug: Aspirin, Drug: Clopidogrel, Drug: Comparator: Placebo (to match Clopidogrel)Clopidogrel - Aspirin - Placebo |
| Sequence 6 | Experimental | Drug: Placebo (to match Aspirin), Drug: Aspirin, Drug: Clopidogrel, Drug: Comparator: Placebo (to match Clopidogrel)Placebo - Clopidogrel - Aspirin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject has BMI (Body Mass Index) less than 32 kg/m^ 2
- Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 3 months
- Subject does not have a history of any bleeding disorder
Key exclusion criteria (8 listed)
- Subject is a pregnant or nursing female
- Subject has a history of multiple and/or severe allergies to drugs or foods, or any history (personal or family) of bleeding disorders (including arterial bleeding, hemorrhage requiring transfusion or urgent intervention)
- Subject currently uses on a regular basis or has used aspirin or clopidogrel within 21 days prior to screening (including low-dose aspirin and pain relievers, cold, or sinus remedies containing aspirin)
- Subject currently uses on a regular basis or has used within 2 weeks prior to study start, any other prescription or nonprescription drugs, including NSAIDs such as ibuprofen, naproxen, COX-II inhibitors such as celecoxib or etoricoxib, other pain relievers, cold, or sinus remedies containing NSAIDs, and herbal remedies (e.g., St. John Wort)
- Subject anticipates needing during the study any prescription or nonprescription (including over the counter) preparation, including those that contain aspirin, ibuprofen, or any other NSAID or NSAID-containing product commonly found in pain relievers, cold or sinus remedies
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 |
|---|---|---|
| Placebo (to match Aspirin)Placebo grossly matched Aspirin 300 mg daily | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| AspirinAspirin 300 mg daily | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| ClopidogrelClopidogrel 75 mg daily | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| Comparator: Placebo (to match Clopidogrel)Placebo (grossly matched Clopidogrel 75 mg) daily | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
The effect size of light transmission platelet aggregation, bleeding time, and several point of care platelet function assays after 3 days of administration of study drug compared to placebo treatment.
Time frame: Baseline and 3 days
The intra-subject coefficient of variation of each of the 3 platelet function devices
Time frame: Baseline and 3 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 13 Aug 2015.
- Derived from this study: PubMed 21919555Chen F, Maridakis V, O'neill EA, Beals C, Radziszewski W, de Lepeleire I, Van Dyck K, Depre M, Bolognese JA, de Hoon J, Jacquemin M. A randomized clinical trial comparing point-of-care platelet function assays and bleeding time in healthy subjects treated with aspirin or clopidogrel. Platelets. 2012;23(4):249-58. doi: 10.3109/09537104.2011.604806. Epub 2011 Sep 15.
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Screening Protocol
Pain
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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aspirin and Clopidogrel in people with Healthy Volunteers, run by Merck Sharp & Dohme LLC.
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 3 inclusion and 8 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 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The effect size of light transmission platelet aggregation, bleeding time, and several point of care platelet function assays after 3 days of administration of study drug compared to placebo treatment. (time frame: Baseline and 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01108588, which also lists 1 linked publication.
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 13 Aug 2015.