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Trial record 16 of 1296 for:    ASPIRIN AND Platelet Aggregation

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

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ClinicalTrials.gov Identifier: NCT04059679
Recruitment Status : Not yet recruiting
First Posted : August 16, 2019
Last Update Posted : August 16, 2019
Sponsor:
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
LifeBridge Health

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Peripheral Artery Disease Drug: Rivaroxaban 2.5 Mg Oral Tablet Drug: Aspirin 81 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Synergistic Influence of Rivaroxaban on Inflammation and Coagulation Biomarkers in Patients With CAD and PAD on Aspirin Therapy
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: EC aspirin (81mg qd) Drug: Aspirin 81 mg
EC aspirin 81 mg qd

Experimental: EC aspirin (81mg qd) plus rivaroxaban (2.5 mg bid) Drug: Rivaroxaban 2.5 Mg Oral Tablet
EC aspirin (81mg qd) plus rivaroxaban (2.5 mg bid)

Drug: Aspirin 81 mg
EC aspirin 81 mg qd




Primary Outcome Measures :
  1. Relative Difference in maximal ADP-induced Platelet Aggregation [ Time Frame: 12 weeks ]
    Relative difference in maximal ADP-induced platelet aggregation between 81mg qd EC aspirin or 81mg qd EC aspirin plus 2.5 mg bid rivaroxaban therapy for 12 weeks.


Secondary Outcome Measures :
  1. Relative differences in TF-thrombin-induced platelet aggregation [ Time Frame: 12 weeks ]
    Relative differences in TF-thrombin-induced platelet aggregation between 81mg qd EC aspirin or 81mg qd EC aspirin plus 2.5 mg bid rivaroxaban therapy for 12 weeks.

  2. Relative differences in alpha- thrombin-induced platelet aggregation [ Time Frame: 12 weeks ]
    Relative differences in alpha- thrombin-induced platelet aggregation between 81mg qd EC aspirin or 81mg qd EC aspirin plus 2.5 mg bid rivaroxaban therapy for 12 weeks.

  3. Relative differences in inflammation biomarkers [ Time Frame: 12 weeks ]
    Relative differences in IL-6, hsCRP, platelet bound p-selectin, VCAM, fibrinogen, oxLDL, oxLDL/atherox, TAT complexes, prothrombin F1+2, D-dimer and FpA (soluble markers) between 81mg qd EC aspirin or 81mg qd EC aspirin plus 2.5 mg bid rivaroxaban therapy for 12 weeks

  4. Relative differences in platelet-fibrin clot characteristics [ Time Frame: 12 weeks ]
    Relative differences in platelet-fibrin clot characteristics between 81mg qd EC aspirin or 81mg qd EC aspirin plus 2.5 mg bid rivaroxaban therapy for 12 weeks

  5. Relative differences in shear-induced platelet aggregation [ Time Frame: 12 weeks ]
    Relative differences in shear-induced platelet aggregation between 81mg qd EC aspirin or 81mg qd EC aspirin plus 2.5 mg bid rivaroxaban therapy for 12 weeks

  6. Relative differences in lag time [ Time Frame: 12 weeks ]
    Relative differences in lag time between 81mg qd EC aspirin or 81mg qd EC aspirin plus 2.5 mg bid rivaroxaban therapy for 12 weeks

  7. Relative differences in peak thrombin production [ Time Frame: 12 weeks ]
    Relative differences in peak thrombin production between 81mg qd EC aspirin or 81mg qd EC aspirin plus 2.5 mg bid rivaroxaban therapy for 12 weeks

  8. Relative differences in mean velocity rate index [ Time Frame: 12 weeks ]
    Relative differences in mean velocity rate index between 81mg qd EC aspirin or 81mg qd EC aspirin plus 2.5 mg bid rivaroxaban therapy for 12 weeks

  9. Relative differences in endogenous thrombin potential [ Time Frame: 12 weeks ]
    Relative differences in endogenous thrombin potential between 81mg qd EC aspirin or 81mg qd EC aspirin plus 2.5 mg bid rivaroxaban therapy for 12 weeks


Other Outcome Measures:
  1. First occurrence of modified ISTH major bleeding [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: 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:

    1. Current smoker (within 1 year of randomization)
    2. Diabetes mellitus
    3. Renal dysfunction with estimated glomerular filtration rate of <60 ml/min
    4. Heart failure
    5. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04059679


Contacts
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Contact: Udaya Tantry, PhD 4106019467 ukstantry@gmail.com

Locations
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United States, Maryland
Sinai Hospital of Baltimore Not yet recruiting
Baltimore, Maryland, United States, 21215
Contact: Udaya Tantry, PhD         
Sponsors and Collaborators
LifeBridge Health
Janssen Scientific Affairs, LLC

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Responsible Party: LifeBridge Health
ClinicalTrials.gov Identifier: NCT04059679     History of Changes
Other Study ID Numbers: 1436289
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aspirin
Platelet Aggregation Inhibitors
Coronary Artery Disease
Peripheral Arterial Disease
Inflammation
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Atherosclerosis
Peripheral Vascular Diseases
Rivaroxaban
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics