Cardiovascular DiseasesPhase 4PADNCT00272311

Aspirin Dose and Atherosclerosis in Patients With Metabolic Syndrome

A Phase 4 study testing Aspirin in people with Cardiovascular Diseases and Metabolic Syndrome X, run by Florida Atlantic 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.

Official record

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Trial summary

The purpose of the study is to test higher versus lower doses of aspirin on markers of atherosclerosis in patients at risk of a first heart attack. Read more about this study

Who is it for?: Ages 40 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Cardiovascular Diseases, Metabolic Syndrome X, Atherosclerosis
What is being tested?: Aspirin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteUnited States
Study dates: Oct 2006to Jan 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 40 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

1. Age 40 to 80 years, inclusive.
2. No previous heart attack or a stroke, or other forms of these diseases.
3. Have at least three of the five characteristics listed below, indicating presence of metabolic syndrome, as defined by NCEP-III:
waist measuring more than 40 inches (for men) or more than 35 inches (for women),
high density lipoprotein (HDL) cholesterol levels lower than 40 milligrams per deciliter (mg/dl) in men or 50 mg/dl in women,
triglyceride (TG) levels above 150 mg/dl,
blood pressure greater than 130 millimeters of mercury (mmHg) systolic or 85 mmHg diastolic,
fasting blood sugar greater than 110 mg/dl

Who cannot join

Patients taking greater than 81mg aspirin daily.
Patients taking anti-platelet drugs such as clopidogrel or non-steroidal anti-inflammatory drugs (NSAIDs) or anticoagulant drugs such as warfarin, during the last two weeks.
Patients taking any of the following medications for less than 3 months, or who plan to take them for the first time during the next 3 months: ACE-inhibitors, angiotensin receptor blockers, calcium channel blockers, or statins.
Patients who are currently cigarette smokers.
Women patients who are pregnant, planning to become pregnant, nursing a child, or taking hormone replacement therapy.
Patients with any coagulation, bleeding or blood disorders.

Show all 15Show fewer

Patients who are sensitive or allergic to aspirin.
Patients with documented history of any gastrointestinal disorders, including bleeding ulcers.
Patients with any evidence of cancer or history of significant cardiovascular disease (including heart attack, stroke or drop attacks termed transient ischemic attacks (TIAs), or blockages of the arteries in the legs termed peripheral arterial disease (PAD)), kidney, liver, lung, blood, or brain disorders.
Patients with asthma, rhinitis, or nasal polyps.
Patients with any abnormal laboratory value or physical finding that, in the view of the responsible clinician, may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety.
Patients with Class IV heart failure.
Patients with severe aortic insufficiency, or aortic regurgitation.
Patients with hearing loss or tinnitus.
Patients with tremors which cause them not to be able to remain motionless for approximately 30 seconds.

Trial locations and contacts

1 site in 1 country.

United States1 site

HeartDrug Research, LLC
Towson, Maryland, 21204

Other trials in United States

About this study

Official title: A Randomized, Double-Blind Trial to Test Higher- Versus Lower-Doses of Aspirin on Inflammatory Markers and Platelet Biomarkers and Nitric Oxide Formation in High Risk Primary Prevention (Patients With Metabolic Syndrome)

The purpose of the study is to test higher versus lower doses of aspirin on markers of atherosclerosis in patients at risk of a first heart attack.

Read the detailed description

Aspirin reduces risks of heart attacks, strokes, and deaths from cardiovascular causes in patients who have survived a prior event as well as during an acute heart attack. Aspirin also prevents a first heart attack.

Low dose aspirin is sufficient to achieve complete inhibition of platelet aggregability, or stickiness, and this is the mechanism whereby aspirin prevents formation of blood clots.

Our research is designed to explore whether higher doses of aspirin provide additional benefits on markers of atherosclerosis.

Conditions: Cardiovascular Diseases, Metabolic Syndrome X, Atherosclerosis
Being tested: Aspirin
Keywords: Primary prevention, Cardiovascular diseases, Aspirin, Metabolic Syndrome X, Atherosclerosis
Medical subject headings: Cardiovascular Diseases, Metabolic Syndrome, Atherosclerosis

What participants receive

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

AspirinDrug
Dosage

Study groups in NCT00272311
Study group	Role	What they receive
1	Active comparator	81 mg Aspirin Receives: Drug: Aspirin
2	Active comparator	162 mg Aspirin Receives: Drug: Aspirin
3	Active comparator	325 mg Aspirin Receives: Drug: Aspirin
4	Active comparator	650 mg Aspirin Receives: Drug: Aspirin
5	Active comparator	1300 mg Aspirin Receives: Drug: Aspirin

What is being measured

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

Change in Nitric Oxide Formation From Baseline to 3 Months
Changes in Heme oxygenase (HO-1) a downstream target of nitric oxide (NO) formation.
Measured: Baseline to 3 Months (90-97 days)

Timeline

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

Oct 2006Jan 2009

First posted5 Jan 2006 (estimated)
Study startOct 2006
Primary completionJan 2009
Study completionJan 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.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseasesStudies 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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00272311
Sponsor's protocol ID: H08-35
Acronym: PAD
Status last verified: Feb 2019
First submitted: 3 Jan 2006
Last updated: 27 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Williams A, Hennekens CH. The role of aspirin in cardiovascular diseases--forgotten benefits? Expert Opin Pharmacother. 2004 Jan;5(1):109-15. doi: 10.1517/14656566.5.1.109.
PubMed 14680440
Hennekens CH, Buring JE, Sandercock P, Collins R, Peto R. Aspirin and other antiplatelet agents in the secondary and primary prevention of cardiovascular disease. Circulation. 1989 Oct;80(4):749-56. doi: 10.1161/01.cir.80.4.749. No abstract available.
PubMed 2676237
Eidelman RS, Hebert PR, Weisman SM, Hennekens CH. An update on aspirin in the primary prevention of cardiovascular disease. Arch Intern Med. 2003 Sep 22;163(17):2006-10. doi: 10.1001/archinte.163.17.2006.
PubMed 14504112
Roth GJ, Stanford N, Majerus PW. Acetylation of prostaglandin synthase by aspirin. Proc Natl Acad Sci U S A. 1975 Aug;72(8):3073-6. doi: 10.1073/pnas.72.8.3073.
PubMed 810797
Patrignani P, Filabozzi P, Patrono C. Selective cumulative inhibition of platelet thromboxane production by low-dose aspirin in healthy subjects. J Clin Invest. 1982 Jun;69(6):1366-72. doi: 10.1172/jci110576.
PubMed 7045161
Reilly IA, FitzGerald GA. Inhibition of thromboxane formation in vivo and ex vivo: implications for therapy with platelet inhibitory drugs. Blood. 1987 Jan;69(1):180-6.
PubMed 3790723
Mustard JF, Packham MA. The role of blood and platelets in atherosclerosis and the complications of atherosclerosis. Thromb Diath Haemorrh. 1975 Jun 30;33(3):444-56.
PubMed 1154306
Mustard JF, Moore S, Packham MA, Kinlough-Rathbone RL. Platelets, thrombosis and atherosclerosis. Prog Biochem Pharmacol. 1977;13:312-25.
PubMed 928433
Mustard JF, Packham MA, Kinlough-Rathbone RL. Platelets and thrombosis in the development of atherosclerosis and its complications. Adv Exp Med Biol. 1978;102:7-30. doi: 10.1007/978-1-4757-1217-9_2. No abstract available.
PubMed 356564
Ikonomidis I, Andreotti F, Economou E, Stefanadis C, Toutouzas P, Nihoyannopoulos P. Increased proinflammatory cytokines in patients with chronic stable angina and their reduction by aspirin. Circulation. 1999 Aug 24;100(8):793-8. doi: 10.1161/01.cir.100.8.793.
PubMed 10458713
Ridker PM, Cushman M, Stampfer MJ, Tracy RP, Hennekens CH. Inflammation, aspirin, and the risk of cardiovascular disease in apparently healthy men. N Engl J Med. 1997 Apr 3;336(14):973-9. doi: 10.1056/NEJM199704033361401.
PubMed 9077376
Hennekens CH, Schror K, Weisman S, FitzGerald GA. Terms and conditions: semantic complexity and aspirin resistance. Circulation. 2004 Sep 21;110(12):1706-8. doi: 10.1161/01.CIR.0000142056.69970.DB. No abstract available.
PubMed 15381661
Steer KA, Wallace TM, Bolton CH, Hartog M. Aspirin protects low density lipoprotein from oxidative modification. Heart. 1997 Apr;77(4):333-7. doi: 10.1136/hrt.77.4.333.
PubMed 9155612
Wu R, Lamontagne D, de Champlain J. Antioxidative properties of acetylsalicylic Acid on vascular tissues from normotensive and spontaneously hypertensive rats. Circulation. 2002 Jan 22;105(3):387-92. doi: 10.1161/hc0302.102609.
PubMed 11804997
Oberle S, Polte T, Abate A, Podhaisky HP, Schroder H. Aspirin increases ferritin synthesis in endothelial cells: a novel antioxidant pathway. Circ Res. 1998 May 18;82(9):1016-20. doi: 10.1161/01.res.82.9.1016.
PubMed 9598599

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 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind Trial to Test Higher- Versus Lower-Doses of Aspirin on Inflammatory Markers and Platelet Biomarkers and Nitric Oxide Formation in High Risk Primary Prevention (Patients With Metabolic Syndrome)
ClinicalTrials.gov ID: NCT00272311
Acronym / sponsor ID: PAD / H08-35
Conditions: Cardiovascular Diseases, Metabolic Syndrome X, Atherosclerosis
Keywords: Primary prevention, Cardiovascular diseases, Aspirin, Metabolic Syndrome X, Atherosclerosis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Florida Atlantic UniversityUniversity, hospital or other
Collaborators: Bayer
Study start: Oct 2006
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 5 Jan 2006 (estimated)
Results: Posted 19 Jun 2012

Clinical summary

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

The purpose of the study is to test higher versus lower doses of aspirin on markers of atherosclerosis in patients at risk of a first heart attack.

Detailed description

Low dose aspirin is sufficient to achieve complete inhibition of platelet aggregability, or stickiness, and this is the mechanism whereby aspirin prevents formation of blood clots.

Our research is designed to explore whether higher doses of aspirin provide additional benefits on markers of atherosclerosis.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
1	Active comparator	Drug: Aspirin81 mg Aspirin
2	Active comparator	Drug: Aspirin162 mg Aspirin
3	Active comparator	Drug: Aspirin325 mg Aspirin
4	Active comparator	Drug: Aspirin650 mg Aspirin
5	Active comparator	Drug: Aspirin1300 mg Aspirin

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

1. Age 40 to 80 years, inclusive.
2. No previous heart attack or a stroke, or other forms of these diseases.
3. Have at least three of the five characteristics listed below, indicating presence of metabolic syndrome, as defined by NCEP-III:

Key exclusion criteria (15 listed)

Patients taking greater than 81mg aspirin daily.
Patients taking anti-platelet drugs such as clopidogrel or non-steroidal anti-inflammatory drugs (NSAIDs) or anticoagulant drugs such as warfarin, during the last two weeks.
Patients taking any of the following medications for less than 3 months, or who plan to take them for the first time during the next 3 months: ACE-inhibitors, angiotensin receptor blockers, calcium channel blockers, or statins.
Patients who are currently cigarette smokers.
Women patients who are pregnant, planning to become pregnant, nursing a child, or taking hormone replacement therapy.

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
AspirinDosage	Drug	1, 2, 3, 4, 5

Primary outcome

Change in Nitric Oxide Formation From Baseline to 3 Months
Time frame: Baseline to 3 Months (90-97 days)
Changes in Heme oxygenase (HO-1) a downstream target of nitric oxide (NO) formation.

Results and safety

Results posted to the registry on 19 Jun 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
Arm 1 of 5 Randomized Treatment Arms	14	14
Arm 2 of 5 Randomized Treatment Arms	14	14
Arm 3 of 5 Randomized Treatment Arms	14	14
Arm 4 of 5 Randomized Treatment Arms	14	14
Arm 5 of 5 Randomized Treatment Arms	14	14

Primary outcome: Change in Nitric Oxide Formation From Baseline to 3 Months

Time frame: Baseline to 3 Months (90-97 days). Mean (Standard Deviation). Unit: ng/mL

Measure	Arm 1 of 5 Randomized Treatment Arms n = 14	Arm 2 of 5 Randomized Treatment Arms n = 11	Arm 3 of 5 Randomized Treatment Arms n = 12	Arm 4 of 5 Randomized Treatment Arms n = 10	Arm 5 of 5 Randomized Treatment Arms n = 13
Value	27.6 (4.9)	27.0 (4.4)	31.4 (9.8)	25.7 (3.4)	28.3 (4.1)

Population analysed: Complete baseline and follow-up data

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1 of 5 Randomized Treatment Arms	0 of 14 (0%)	0 of 14 (0%)	Not reported
Arm 2 of 5 Randomized Treatment Arms	0 of 14 (0%)	0 of 14 (0%)	Not reported
Arm 3 of 5 Randomized Treatment Arms	0 of 14 (0%)	0 of 14 (0%)	Not reported
Arm 4 of 5 Randomized Treatment Arms	0 of 14 (0%)	0 of 14 (0%)	Not reported
Arm 5 of 5 Randomized Treatment Arms	0 of 14 (0%)	0 of 14 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 14680440Williams A, Hennekens CH. The role of aspirin in cardiovascular diseases--forgotten benefits? Expert Opin Pharmacother. 2004 Jan;5(1):109-15. doi: 10.1517/14656566.5.1.109.
Background: PubMed 2676237Hennekens CH, Buring JE, Sandercock P, Collins R, Peto R. Aspirin and other antiplatelet agents in the secondary and primary prevention of cardiovascular disease. Circulation. 1989 Oct;80(4):749-56. doi: 10.1161/01.cir.80.4.749. No abstract available.
Background: PubMed 14504112Eidelman RS, Hebert PR, Weisman SM, Hennekens CH. An update on aspirin in the primary prevention of cardiovascular disease. Arch Intern Med. 2003 Sep 22;163(17):2006-10. doi: 10.1001/archinte.163.17.2006.
Background: PubMed 810797Roth GJ, Stanford N, Majerus PW. Acetylation of prostaglandin synthase by aspirin. Proc Natl Acad Sci U S A. 1975 Aug;72(8):3073-6. doi: 10.1073/pnas.72.8.3073.
Background: PubMed 7045161Patrignani P, Filabozzi P, Patrono C. Selective cumulative inhibition of platelet thromboxane production by low-dose aspirin in healthy subjects. J Clin Invest. 1982 Jun;69(6):1366-72. doi: 10.1172/jci110576.
Background: PubMed 3790723Reilly IA, FitzGerald GA. Inhibition of thromboxane formation in vivo and ex vivo: implications for therapy with platelet inhibitory drugs. Blood. 1987 Jan;69(1):180-6.
Background: PubMed 1154306Mustard JF, Packham MA. The role of blood and platelets in atherosclerosis and the complications of atherosclerosis. Thromb Diath Haemorrh. 1975 Jun 30;33(3):444-56.
Background: PubMed 928433Mustard JF, Moore S, Packham MA, Kinlough-Rathbone RL. Platelets, thrombosis and atherosclerosis. Prog Biochem Pharmacol. 1977;13:312-25.
Background: PubMed 356564Mustard JF, Packham MA, Kinlough-Rathbone RL. Platelets and thrombosis in the development of atherosclerosis and its complications. Adv Exp Med Biol. 1978;102:7-30. doi: 10.1007/978-1-4757-1217-9_2. No abstract available.
Background: PubMed 10458713Ikonomidis I, Andreotti F, Economou E, Stefanadis C, Toutouzas P, Nihoyannopoulos P. Increased proinflammatory cytokines in patients with chronic stable angina and their reduction by aspirin. Circulation. 1999 Aug 24;100(8):793-8. doi: 10.1161/01.cir.100.8.793.
Background: PubMed 9077376Ridker PM, Cushman M, Stampfer MJ, Tracy RP, Hennekens CH. Inflammation, aspirin, and the risk of cardiovascular disease in apparently healthy men. N Engl J Med. 1997 Apr 3;336(14):973-9. doi: 10.1056/NEJM199704033361401.
Background: PubMed 15381661Hennekens CH, Schror K, Weisman S, FitzGerald GA. Terms and conditions: semantic complexity and aspirin resistance. Circulation. 2004 Sep 21;110(12):1706-8. doi: 10.1161/01.CIR.0000142056.69970.DB. No abstract available.

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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.

Charles H Hennekens, MD, DrPH principal investigator

Florida Atlantic University

Wendy R Schneider, MSN, CCRC study director

Florida Atlantic University

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 Cardiovascular Diseases and Metabolic Syndrome X, run by Florida Atlantic 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 8 inclusion and 15 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 27 Feb 2019. 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 19 Jun 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?

Change in Nitric Oxide Formation From Baseline to 3 Months (time frame: Baseline to 3 Months (90-97 days)). 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 NCT00272311, which also lists 20 linked publications.

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 27 Feb 2019.