Synergistic Influence of Rivaroxaban on Inflammation and Coagulation Biomarkers in Patients With CAD and PAD on Aspirin Therapy

  • STATUS
    Recruiting
  • End date
    Aug 21, 2021
  • participants needed
    30
  • sponsor
    LifeBridge Health
Updated on 21 October 2020
Investigator
Udaya Tantry, PhD
Primary Contact
Sinai Hospital of Baltimore (7.8 mi away) Contact
arteriopathy
atherosclerosis
diabetes
angiography
stenosis
aspirin
clot
stroke
myocardial infarction
infarct
percutaneous coronary intervention
ischemia
bypass graft
rivaroxaban
platelet aggregation
vascular disease
coronary disease
bypass surgery
arterial disease
intermittent claudication
duplex ultrasound

Summary

This is a phase IV, prospective biomarker study that will be conducted at Sinai Hospital of Baltimore. After screening for patients who were treated with aspirin, thirty patients will be treated with 81 mg enteric coated (EC) aspirin for 7 days in the "lead-in" period and then will be randomly treated with EC aspirin (81mg qd) or EC aspirin (81mg qd) plus rivaroxaban (2.5 mg bid) for 12 weeks. Platelet aggregation, soluble markers of platelet activation and inflammation, thrombin generation kinetics and tissue factor (TF)-induced platelet-fibrin clot strength will be assessed at baseline (after 7 days of treatment with 81 mg EC aspirin), and 4 and 12 weeks after randomization of the study drug administration.

Details
Treatment Aspirin 81 mg, Rivaroxaban 2.5 Mg Oral Tablet
Clinical Study IdentifierNCT04059679
SponsorLifeBridge Health
Last Modified on21 October 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Coronary heart disease or Coronary Artery Disease or Peripheral Arterial Disease (PAD) or peripheral arterial disease?
to qualify, all subjects must meet have CAD and PAD as
according to criteria specified below
Subjects meeting criteria for CAD$ must have one or more of the following
Myocardial infarction within the past 20 years, or
Multivessel coronary disease with symptoms or with history of stable or unstable angina, or
Multivessel percutaneous coronary intervention, or
Multivessel CABG surgery ( Refers to stenosis of 50% in 2 or more coronary arteries, confirmed using invasive coronary angiography, or noninvasive imaging or stress studies (eg, exercise or pharmacologic) suggestive of significant ischemia in 2 coronary territories; or in 1 coronary territory if at least 1 other territory has been revascularized.)
$Subjects with the qualifying criteria of CAD must also met at least one of
the following
criteria
Age > 65 years, or
Age <65 years and documented atherosclerosis or revascularization involving at least 2 vascular beds+, or at least 2 additional cardiovascular risk factors
Current smoker (within 1 year of randomization)
Diabetes mellitus
Renal dysfunction with estimated glomerular filtration rate of <60 ml/min
Heart failure
Non-lacunar ischemic stroke > 1 month ago
Because CAD involves disease in the coronary vasculature, only one additional vascular bed is required: e.g. the aorta and arterial supply to the brain, gastro-intestinal tract, lower limbs, upper limbs, or kidneys
Subjects meeting criteria for PAD must have one or more of the following
Previous aorto-femoral bypass surgery, limb bypass surgery, or percutaneous transluminal angioplasty revascularization of the iliac, or infrainguinal arteries, or
Previous limb or foot amputation for arterial vascular disease (i.e., excludes trauma), or
History of intermittent claudication and one of the following
An ankle/arm blood pressure (BP) ratio < 0.90
Significant peripheral artery or venous stenosis of 50% documented by angiography or by duplex ultrasound
Previous carotid revascularization or asymptomatic carotid artery stenosis 50% as diagnosed using duplex ultrasound or angiography
Subject may be of either sex and of any race, and must be >18 years of age
Subject agrees to not participate in any other investigational or invasive clinical study for a period of 4 months during the study period
The subject is able to read and has signed and dated the informed consent document including authorization permitting release of personal health information approved by the investigator's Institutional Review Board (IRB)

Exclusion Criteria

Subjects will be excluded from entry if ANY of the
criteria listed below are met
High risk of bleeding
Stroke within 1 month or any history of hemorrhagic or lacunar stroke
Severe heart failure with known ejection fraction <30% or New York Heart Association (NYHA) class III or IV symptoms
Estimated glomerular filtration rate (eGFR)<15 mL/min
Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral anticoagulant therapy
Known non-cardiovascular disease that is associated with poor prognosis (e.g., metastatic cancer) or that increases the risk of an adverse reaction to study interventions
History of hypersensitivity or known contraindication for rivaroxaban, aspirin, or its excipients. Systemic treatment with strong inhibitors of both CYP 3A4 and p-glycoprotein (P-gp) (e.g., systemic azole antimycotics, such as ketoconazole, and human immunodeficiency virus [HIV]-protease inhibitors, such as ritonavir), or strong inducers of CYP 3A4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin, and carbamazepine
Participation in any investigational study within the last 60 days
Active liver disease or hepatic dysfunction, defined as AST or ALT >3 x ULN as determined by laboratory test results drawn at or available during screening
Recipient of any major organ transplant (e.g., lung, liver, heart, bone marrow, renal)
Subjects with prosthetic heart valves
Known major active infection or major hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction in the judgment of the investigator
Malignancy (except non-melanoma skin cancers, cervical in situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 5 years
Subject is pregnant or breast feeding, or planning to become pregnant or to breastfeed during receipt of investigational products and within 15 weeks after the end of study treatment
Female subject who is unwilling to use at least 2 effective birth control methods for at least 1 month before screening and 15 weeks after the end of treatment with investigational products, unless the subject is sterilized or postmenopausal
Subject likely to not be available to complete all protocol-required study visits or procedures, to the best of the subject's and investigator's knowledge
History or evidence of any other clinically significant disorder, condition, or disease other than those outlined above that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
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