HematologyPhase 1KontaktNCT02229461

Naproxen Sodium/ASA Platelet Study

A Phase 1 study testing Naproxen Sodium (Aleve, BAY117031) and Acetylsalicylic Acid (Aspirin, BAYE4465) in people with Hematology, run by Bayer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To determine if administration of naproxen sodium 220 mg maintains the platelet inhibitory effect of a low dose Immediate Release Aspirin (IR ASA) regimen. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Hematology
What is being tested?: Naproxen Sodium (Aleve, BAY117031) and Acetylsalicylic Acid (Aspirin, BAYE4465)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 117 participants
Where: 1 siteUnited States
Study dates: Feb 2015to May 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy, ambulatory, male and female volunteers between 18 - 70 years of age with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2, and a total body weight > 50 kg (110 lbs)
Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera®, or a double barrier and have a negative pregnancy test at Screening and immediately prior to investigational product administration on Day 1 and Day 6. Female subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the Principal Investigator and the Sponsor
Be willing and able to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the protocol
Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial.

Who cannot join

History of hypersensitivity or asthma type symptoms with use of aspirin, naproxen sodium and similar pharmacological agents or components of the products
Females who are pregnant or lactating
Any disorder of the Aspirin Triad Syndrome (i.e., asthma, rhinitis or nasal polyps), or have chronic urticaria
Eighteen to twenty years old with a viral infection, with or without fever within one month prior to start of Run-in Period
History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, infectious diseases or malignancies

Show all 10Show fewer

Any abnormal laboratory value or physical finding that according to the Investigator that may interfere with the interpretation of the study results or be indicative of an underlying disease state
Have taken any medications including NSAIDs (except acceptable forms of birth control) within 7 days prior to the start of the Run-in Period or throughout the study, unless in the opinion of the Investigator and the Sponsor, the medication will not interfere with the study procedures, data integrity, data interpretation or compromise the safety of the subject
Have taken antiplatelet or anticoagulant drugs within 30 days prior to start of the Run-in Period or during their participation in the study
Have donated blood or blood components within 30 days prior to study entry

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Austin, Texas, 78744

Other trials in United States

About this study

Official title: A Randomized, Open Label, Parallel Group Study to Investigate the Effects on Serum Thromboxane by the Addition of Naproxen Sodium to Aspirin Therapy Versus Aspirin Therapy Alone

To determine if administration of naproxen sodium 220 mg maintains the platelet inhibitory effect of a low dose Immediate Release Aspirin (IR ASA) regimen.

Conditions: Hematology
Being tested: Naproxen Sodium (Aleve, BAY117031), Acetylsalicylic Acid (Aspirin, BAYE4465)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Naproxen Sodium (Aleve, BAY117031)Drug
Naproxen sodium 220 mg qd or bid
Acetylsalicylic Acid (Aspirin, BAYE4465)Drug
ASA 81 mg qd

Study groups in NCT02229461
Study group	Role	What they receive
IR ASA co-administered with naproxen sodium	Experimental	Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. Receives: Drug: Naproxen Sodium (Aleve, BAY117031); Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
IR ASA 30 min after naproxen sodium	Experimental	Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. Receives: Drug: Naproxen Sodium (Aleve, BAY117031); Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
IR ASA 8 hours after naproxen sodium	Experimental	Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. Receives: Drug: Naproxen Sodium (Aleve, BAY117031); Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
IR ASA only	Active comparator	Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed. Receives: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
IR ASA 30 min before naproxen sodium	Experimental	Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. Receives: Drug: Naproxen Sodium (Aleve, BAY117031); Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
IR ASA 30 min after first dose of naproxen sodium bid	Experimental	Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. Receives: Drug: Naproxen Sodium (Aleve, BAY117031); Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

What is being measured

The primary outcome is the main question the study is designed to answer.

Inhibition of Serum Thromboxane B2 (TXB2) on Day 16 at 24 Hour Post IR ASA 81 mg Administration
Inhibition of serum TXB2 at specified time point was calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% Confidence Interval (CI) were calculated.
Measured: At hour 24 on Day 16 post treatment

Secondary outcomes (3)

Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Inhibition of serum TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.
Measured: At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19 (except 24 hours on Day 16)
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Inhibition of AA-induced platelet aggregation at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated. The platelet aggregation change-from-baseline scores range broadly in large part due to inclusion of participants with low baseline platelet aggregation scores.
Measured: At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Inhibition of plasma TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.
Measured: At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015May 2015

First posted1 Sep 2014 (estimated)
Study startFeb 2015
Primary completionMay 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HematologyStudies of the same condition, open and under way.
More trials run by BayerThe 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: Parallel groups
Masking: None (open label)
Enrolment: 117 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02229461
Sponsor's protocol ID: 15525
Acronym: Kontakt
Status last verified: Jun 2016
First submitted: 31 Jul 2014
Last updated: 15 Jul 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Gurbel PA, Bliden KP, Zhu J, Troullos E, Centofanti R, Jarvis S, Venkataraman P, Tantry US. Thromboxane inhibition during concurrent therapy with low-dose aspirin and over-the-counter naproxen sodium. J Thromb Thrombolysis. 2018 Jan;45(1):18-26. doi: 10.1007/s11239-017-1593-y.
PubMed 29198079

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open Label, Parallel Group Study to Investigate the Effects on Serum Thromboxane by the Addition of Naproxen Sodium to Aspirin Therapy Versus Aspirin Therapy Alone
ClinicalTrials.gov ID: NCT02229461
Acronym / sponsor ID: Kontakt / 15525
Conditions: Hematology
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 117 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: Feb 2015
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 1 Sep 2014 (estimated)
Results: Posted 10 Jun 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To determine if administration of naproxen sodium 220 mg maintains the platelet inhibitory effect of a low dose Immediate Release Aspirin (IR ASA) regimen.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
IR ASA co-administered with naproxen sodium	Experimental	Drug: Naproxen Sodium (Aleve, BAY117031), Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
IR ASA 30 min after naproxen sodium	Experimental	Drug: Naproxen Sodium (Aleve, BAY117031), Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
IR ASA 8 hours after naproxen sodium	Experimental	Drug: Naproxen Sodium (Aleve, BAY117031), Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
IR ASA only	Active comparator	Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
IR ASA 30 min before naproxen sodium	Experimental	Drug: Naproxen Sodium (Aleve, BAY117031), Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
IR ASA 30 min after first dose of naproxen sodium bid	Experimental	Drug: Naproxen Sodium (Aleve, BAY117031), Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Healthy, ambulatory, male and female volunteers between 18 - 70 years of age with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2, and a total body weight > 50 kg (110 lbs)
Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera®, or a double barrier and have a negative pregnancy test at Screening and immediately prior to investigational product administration on Day 1 and Day 6. Female subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the Principal Investigator and the Sponsor
Be willing and able to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the protocol
Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial.

Key exclusion criteria (10 listed)

History of hypersensitivity or asthma type symptoms with use of aspirin, naproxen sodium and similar pharmacological agents or components of the products
Females who are pregnant or lactating
Any disorder of the Aspirin Triad Syndrome (i.e., asthma, rhinitis or nasal polyps), or have chronic urticaria
Eighteen to twenty years old with a viral infection, with or without fever within one month prior to start of Run-in Period
History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)

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
Naproxen Sodium (Aleve, BAY117031)Naproxen sodium 220 mg qd or bid	Drug	IR ASA 30 min after first dose of naproxen sodium bid, IR ASA 30 min after naproxen sodium, IR ASA 30 min before naproxen sodium, IR ASA 8 hours after naproxen sodium, IR ASA co-administered with naproxen sodium
Acetylsalicylic Acid (Aspirin, BAYE4465)ASA 81 mg qd	Drug	IR ASA 30 min after first dose of naproxen sodium bid, IR ASA 30 min after naproxen sodium, IR ASA 30 min before naproxen sodium, IR ASA 8 hours after naproxen sodium, IR ASA co-administered with naproxen sodium, IR ASA only

Primary outcome

Inhibition of Serum Thromboxane B2 (TXB2) on Day 16 at 24 Hour Post IR ASA 81 mg Administration
Time frame: At hour 24 on Day 16 post treatment
Inhibition of serum TXB2 at specified time point was calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% Confidence Interval (CI) were calculated.

3 secondary outcomes

Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
Time frame: At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19 (except 24 hours on Day 16)
Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Time frame: At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19
Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
Time frame: At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19

Results and safety

Results posted to the registry on 10 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1-IR ASA Co-administered With Naproxen Sodium	17	17
Group 2-IR ASA 30 Min After Naproxen Sodium	17	17
Group 3-IR ASA 8 Hours After Naproxen Sodium	17	17
Group 4-IR ASA Only	17	17
Group 5-IR ASA 30 Min Before Naproxen Sodium	17	17
Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid	17	17

Primary outcome: Inhibition of Serum Thromboxane B2 (TXB2) on Day 16 at 24 Hour Post IR ASA 81 mg Administration

Time frame: At hour 24 on Day 16 post treatment. Mean (95% Confidence Interval). Unit: percentage

Measure	Group 1-IR ASA Co-administered With Naproxen Sodium n = 13	Group 2-IR ASA 30 Min After Naproxen Sodium n = 14	Group 3-IR ASA 8 Hours After Naproxen Sodium n = 15	Group 4-IR ASA Only n = 13	Group 5-IR ASA 30 Min Before Naproxen Sodium n = 10	Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid n = 15
Value	93.09 (91.50 to NA)	87.71 (85.51 to NA)	92.87 (91.24 to NA)	98.72 (98.49 to NA)	95.35 (94.14 to NA)	95.65 (94.74 to NA)

Population analysed: Percentages are based on the number of participants in the Evaluable Population in each treatment group.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 0-IR ASA 81 mg qd in Run-in Period	0 of 102 (0%)	0 of 102 (0%)	Not reported
Group 1-IR ASA Co-administered With Naproxen Sodium	0 of 17 (0%)	4 of 17 (23.5%)	Not reported
Group 2-IR ASA 30 Min After Naproxen Sodium	0 of 17 (0%)	1 of 17 (5.9%)	Not reported
Group 3-IR ASA 8 Hours After Naproxen Sodium	0 of 17 (0%)	4 of 17 (23.5%)	Not reported
Group 4-IR ASA Only	0 of 17 (0%)	3 of 17 (17.6%)	Not reported
Group 5-IR ASA 30 Min Before Naproxen Sodium	0 of 17 (0%)	2 of 17 (11.8%)	Not reported
Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid	0 of 17 (0%)	4 of 17 (23.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29198079Gurbel PA, Bliden KP, Zhu J, Troullos E, Centofanti R, Jarvis S, Venkataraman P, Tantry US. Thromboxane inhibition during concurrent therapy with low-dose aspirin and over-the-counter naproxen sodium. J Thromb Thrombolysis. 2018 Jan;45(1):18-26. doi: 10.1007/s11239-017-1593-y.

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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.

Bayer Study Director study director

Bayer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Naproxen Sodium (Aleve, BAY117031) and Acetylsalicylic Acid (Aspirin, BAYE4465) in people with Hematology, run by Bayer at 1 site in United States.

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 5 inclusion and 10 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 15 Jul 2016. 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 United States. 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.

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?

Yes. Results are posted in the registry (first posted 10 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Inhibition of Serum Thromboxane B2 (TXB2) on Day 16 at 24 Hour Post IR ASA 81 mg Administration (time frame: At hour 24 on Day 16 post treatment). 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 NCT02229461, 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 15 Jul 2016.