Aspirin 81Mg Ec Tab for Peripheral Arterial Disease

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Vanderbilt University Medical Center, Nashville, TN
Peripheral Arterial Disease+2 More
Aspirin 81Mg Ec Tab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called rivaroxaban can improve symptoms associated with peripheral artery disease.

See full description

Eligible Conditions

  • Peripheral Arterial Disease

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

This trial is evaluating whether Aspirin 81Mg Ec Tab will improve 6 primary outcomes, 18 secondary outcomes, and 4 other outcomes in patients with Peripheral Arterial Disease. Measurement will happen over the course of Baseline to 37 days.

Baseline to 37 days
CD41a (Integrin alpha-II-beta)
CD62p (P-Selectin)
Change in Endogenous PAR-1 activation as measured by flow cytometry
Change in endothelium-dependent, flow-mediated dilation (FMD) of the brachial artery
Change in fibrinolysis as measured by anti-factor Xa activity
Change in inflammation as measured by high sensitivity C-reactive protein.
Change in optical aggregation of platelets using PAR-1-agonist peptide
Change in optical aggregation of platelets using tissue factor
Change in peripheral artery disease as measured by a 4-meter walk speed test
Change in peripheral artery disease as measured by a 6 minute walk test
Change in serum thromboxane B2 as measured by gas chromatography
Change in serum thromboxane B2 as measured by mass spectrometry
Change in thrombosis as measured by partial thromboplastin time
Change in thrombosis as measured by prothrombin time
Change of microvascular endothelial function
D-Dimer
Endogenous PAR-1 activation as measured by flow cytometry
Endothelium-dependent, flow-mediated dilation (FMD) of the brachial artery
High-sensitivity C-reactive protein.
Interleukin-1beta
Interleukin-6
Monocyte chemoattractant protein-1 (MCP-1)
Partial thromboplastin time
Plasminogen activator inhibitor 1 (PAI-1)
Prothrombin time
Soluble intercellular adhesion molecule-1 (slCAM-1)
Tumor necrosis factor-alpha
von Willebrand factor (vWF)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Intervention
1 of 2
Control
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 75 total participants across 2 different treatment groups

This trial involves 2 different treatments. Aspirin 81Mg Ec Tab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

InterventionParticipants will receive 81mg of aspirin + rivaroxaban 2.5mg twice daily for 30 days.
ControlParticipants will receive 81mg daily of aspirin + placebo for 30 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rivaroxaban
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 37 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to 37 days for reporting.

Who is running the study

Principal Investigator
A. W. A.
Prof. Aaron W. Aday,c, MD
Vanderbilt University Medical Center

Closest Location

Vanderbilt University Medical Center - Nashville, TN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Previous aorto-femoral bypass surgery, limb bypass surgery, or percutaneous transluminal angioplasty revascularization of the iliac or infra-inguinal arteries, or Previous limb or foot amputation for arterial vascular disease, or An ankle/arm blood pressure (BP) ratio < 0.90, or Significant peripheral artery stenosis (≥50%) documented by angiography, or by duplex ultrasound
Willing and able to provide written informed consent
Age ≥65, or Age <65 and documented atherosclerosis or revascularization involving at least 2 vascular beds (lower extremity PAD, coronary artery disease, and/or carotid artery stenosis)
Receiving aspirin therapy prior to enrollment

Patient Q&A Section

What causes thrombus?

"Patients without a known thromboembolic risk, with and without aortic valve disease, who develop symptomatic thrombus may be found to have atrial fibrillation and/or hypertension. Patients with a known thromboembolic risk, with or without underlying aortic valve disease, should be evaluated as patients are found to have a high (3% or greater) long-term risk of thromboembolism." - Anonymous Online Contributor

Unverified Answer

What is thrombus?

"Thrombus is a blood clot that interrupts circulation by disrupting blood flow through a blood vessel. If left untreated, thrombus may lead to heart attacks and possibly death. In the case of heart attacks, a thrombus can be surgically removed. Thrombus, and related condition thrombophlebitis, can contribute to the development of deep vein thrombosis (DVT)." - Anonymous Online Contributor

Unverified Answer

How many people get thrombus a year in the United States?

"Results from a recent paper suggests that a significant proportion of the population (29.3%) of Caucasian women and 20.4% of African American women are unlikely to get adequate antithrombotic prophylaxis. This is a matter that warrants broader study since thrombotic events are an important cause of morbidity and mortality." - Anonymous Online Contributor

Unverified Answer

What are the signs of thrombus?

"Thrombus usually presents with dyspnea, pain and ischemia. Other signs include fever and erythrocyte disturbances. Thrombus on cardiac imaging is an important clue to the diagnosis of thrombus that requires urgent investigation with echocardiography. Followup of thrombosis should be considered in all patients presenting with thrombotic complications. Physicians must be aware of the signs of thrombus in the presentation of patients with a thrombus." - Anonymous Online Contributor

Unverified Answer

What are common treatments for thrombus?

"Thrombus is generally associated with long-term disability and is often a cause for a myocardial infarction. The treatments for thrombus depend on the underlying disease, the anatomical position and physical symptoms.\n" - Anonymous Online Contributor

Unverified Answer

Can thrombus be cured?

"Although the pathogenesis for thrombosis, deep-seated thrombosis in particular, is very complex, the optimal treatment still has not been identified with certainty. Many of the same considerations apply to other thromboses. There is no certainty that thrombus can be cured by any treatment modality." - Anonymous Online Contributor

Unverified Answer

Is aspirin 81mg ec tab typically used in combination with any other treatments?

"Aspirin 81mg ec tab is commonly used, but there is no clear evidence of the effect of the medication by itself compared to placebo in this setting. In this setting, more information is needed to clarify the role of aspirin itself." - Anonymous Online Contributor

Unverified Answer

What is aspirin 81mg ec tab?

"[Oxygen is needed by the cells in the intestines to form blood clots in order to stop bleeding. This is why patients must consume more oral dietary magnesium if they are taking aspirin. Magnesium binds and inactivates two of the three major enzymes involved in creating prothrombotic clots, which are ADP, PAI-1, and thrombin. Thus, patients taking aspirin should be taking dietary magnesium as well as taking supplemental vitamin B12, at least in the long term.](https://www.brit-wellorg"

"Chromide\n\nChromide is a common name for the chemical compounds and salts with the formula." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for thrombus?

"Although the majority of our patients did not qualify for a trial, we consider prospective evaluation of patients who have thrombus to be an effective strategy for thrombotic disease." - Anonymous Online Contributor

Unverified Answer

How does aspirin 81mg ec tab work?

"Recent findings does not provide evidence to support the hypothesis that 1.75 mg aspirin-eco [TC] is less effective at inhibiting thrombosis than either 6.25 or 81 mg aspirin-eco [IT]. This trial, in conjunction with other evidence, appears to indicate that aspirin-eco [IT] is as effective as the [IT] of other anti-platelet medications, such as clopidogrel." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of thrombus?

"The clinical practice of performing ultrasonography in patients with a clinically suspected DVT or other peripheral vascular symptoms may increase the number of thrombi which may not be detected on a routine venous duplex scan. However, routine Doppler ultrasonography should always be performed in all patients for optimal patient management." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving aspirin 81mg ec tab?

"Although the current trial does not include a [primary endpoint for the study comparing 81mg ec tab versus placebo in reducing the risk of ischemic stroke or [major adverse cardiovascular events], it is noteworthy that ischemic events occurred with significantly lower frequency than noted in clinical trials of high-dose aspirin and [aspirin 81mg ec tab]. This finding may be due to the lower dose used relative to the clinical trials reported in the medical literature. Because a lower-than-usual dose of aspirin is associated with reductions in cardiovascular, cardiovascular death, and all-cause mortality, including ischemic events, physicians were advised to provide patients with aspirin 81mg ec tab." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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