Heart DiseasePhase 4NCT00818337

Aspirin Responsiveness in Women at Risk for Cardiac Events

A Phase 4 study testing Aspirin in people with Heart Disease, run by Creighton University at 1 site in United States.

Completed

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

Trial summary

The objective of this pilot study is to evaluate the prevalence of biological aspirin resistance in women at risk for CHD taking low dose (81 mg) aspirin. Aspirin responsiveness will be measured with the VerifyNow device (Accumetrics; San Diego, CA). Read more about this study

Who is it for?: Ages 19 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Heart Disease
What is being tested?: Aspirin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: Nov 2008to Jun 2009
Phase: Phase 4
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 19 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Women at least 19 years old
Taking 81 mg aspirin daily, non-enteric coated, for at least one month for the primary prevention of cardiovascular disease.
Able and willing to provide informed consent

Who cannot join

Pregnancy or breastfeeding
Known CHD
Currently taking clopidogrel or ticlopidine
Use of heparin, warfarin, or glycoprotein IIb/IIIa inhibitors within previous 96 hours
Allergy or hypersensitivity to salicylates
Use of other OTC or prescription analgesics or anti-inflammatory medication in the past two weeks
Currently participating in another investigational drug or device study

Trial locations and contacts

1 site in 1 country.

United States1 site

The Cardiac Center at Creighton University
Omaha, Nebraska, 68131

Other trials in United States

About this study

Official title: Aspirin Responsiveness in Women at Risk for Cardiac Events: A Pilot Study.

Conditions: Heart Disease
Being tested: Aspirin
Medical subject headings: Heart Diseases

What participants receive

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

AspirinDrug
Aspirin 81mg and Aspirin 325mg, non-enteric coated, take one tablet by mouth daily

Study groups in NCT00818337
Study group	Role	What they receive
Aspirin 81mg	Active comparator	Resistant Receives: Drug: Aspirin

What is being measured

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

Number of Women Aspirin Resistant
Aspirin responsive unit (ARU) > 550 was considered to be aspirin resistant and correlates to less than 50% inhibition of platelet aggregation.
Measured: Baseline

Secondary outcomes (1)

Number of Aspirin Resistant Who Became Responders After Increase to Aspirin 325 mg
Aspirin resistance was defined as ARU > 550
Measured: 2 weeks

Timeline

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

Nov 2008Jun 2009

First posted7 Jan 2009 (estimated)
Study startNov 2008
Primary completionJun 2009
Study completionJun 2009

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.
Other trials for Heart DiseaseStudies 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 4
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00818337
Sponsor's protocol ID: 08-14888
Status last verified: Nov 2012
First submitted: 6 Jan 2009
Last updated: 4 Dec 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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?

See locations

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All Heart Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Aspirin Responsiveness in Women at Risk for Cardiac Events: A Pilot Study.
ClinicalTrials.gov ID: NCT00818337
Acronym / sponsor ID: 08-14888
Conditions: Heart Disease
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Creighton UniversityUniversity, hospital or other
Study start: Nov 2008
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 7 Jan 2009 (estimated)
Results: Posted 4 Dec 2012

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Aspirin 81mg	Active comparator	Drug: AspirinResistant

Who may qualify

Ages: 19 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Women at least 19 years old
Taking 81 mg aspirin daily, non-enteric coated, for at least one month for the primary prevention of cardiovascular disease.
Able and willing to provide informed consent

Key exclusion criteria (7 listed)

Pregnancy or breastfeeding
Known CHD
Currently taking clopidogrel or ticlopidine
Use of heparin, warfarin, or glycoprotein IIb/IIIa inhibitors within previous 96 hours
Allergy or hypersensitivity to salicylates

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
AspirinAspirin 81mg and Aspirin 325mg, non-enteric coated, take one tablet by mouth daily	Drug	Aspirin 81mg

Primary outcome

Number of Women Aspirin Resistant
Time frame: Baseline
Aspirin responsive unit (ARU) > 550 was considered to be aspirin resistant and correlates to less than 50% inhibition of platelet aggregation.

1 secondary outcome

Number of Aspirin Resistant Who Became Responders After Increase to Aspirin 325 mg
Time frame: 2 weeks

Results and safety

Results posted to the registry on 4 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aspirin 81mg	36	36

Primary outcome: Number of Women Aspirin Resistant

Time frame: Baseline. Number. Unit: participants

Measure	Aspirin 81 mg n = 36
Value	3

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aspirin 81mg	0 of 36 (0%)	0 of 36 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Heart Disease

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Active, not recruiting
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aspirin in people with Heart Disease, run by Creighton University 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 3 inclusion and 7 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 4 Dec 2012. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 4 Dec 2012). 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?

Number of Women Aspirin Resistant (time frame: Baseline). 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 NCT00818337.

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 4 Dec 2012.