NCT03699293

Brief Summary

The objectives of this single site, randomized, crossover study is to evaluate the pharmacodynamic interactions between aspirin, NSAIDs and Coxibs with respect to platelet function, biomarkers of inflammation and endothelial function.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Sep 2018

Shorter than P25 for phase_4 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

September 22, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2019

Completed
Last Updated

October 9, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

September 21, 2018

Last Update Submit

October 4, 2018

Conditions

Rheumatoid ArthritisCardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Platelet aggregation

    Change in platelet aggregation by light transmittance aggregometry between treatment groups

    12 weeks

Secondary Outcomes (7)

  • Serum TxB2

    12 weeks

  • Urine thromboxane

    12 weeks

  • Urine 8 iso prostaglandin

    12 weeks

  • Endothelial function by EndoPAT

    12 weeks

  • Soluble markers of circulating adhesion molecules (VCAM, ICAM).

    12 weeks

  • +2 more secondary outcomes

Study Arms (2)

ASA and Celecoxib

ACTIVE COMPARATOR

Take celecoxib 200mg capsule twice a day and aspirin 81mg tablet once a day for 4 weeks (after completion of the run-in period)

Drug: celecoxib 200mg capsuleDrug: Aspirin 81mg tablet

ASA and Naproxen

ACTIVE COMPARATOR

Take naproxen sodium 550mg tablet twice a day and aspirin 81mg tablet once a day (after completion of the run-in period)

Drug: naproxen sodium 550mg tabletDrug: Aspirin 81mg tablet

Interventions

celecoxib 200mg capsuleDRUG

celecoxib 200mg twice a day for 4 weeks

Also known as: Celebrex
ASA and Celecoxib
naproxen sodium 550mg tabletDRUG

naproxen sodium 550mg twice a day for 4 weeks

Also known as: Aleve, Naprosyn
ASA and Naproxen
Aspirin 81mg tabletDRUG

81mg aspirin for 4 weeks in the run-in period, and for 8 weeks during treatment and crossover period

Also known as: Bayer Aspirin
ASA and CelecoxibASA and Naproxen

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years of age for patients who regularly use NSAIDs.
  • Age 18-65 years of age for patients who do not regularly use NSAIDs
  • Able to give informed consent
  • Subjects with CVD or increased CV risk. Please see definitions for each criteria below:
  • Increased CV risk (Subjects should have at least 3 of the following)
  • \> 55 years of age
  • Hypertension
  • Dyslipidemia (LDL \> 160 mg/dL or HDL \< 40 mg/dL in females and \< 35 mg/dL in males or subjects currently receiving lipid lowering therapy as standard of care (i.e. statin drugs, prescription ω 3-acid ethyl esters, fibrates or prescription niacin \[≥1,000 mg/d\])
  • Family history of premature CV disease (MI, angina pectoris, heart failure, cardiac death or coronary revascularization, stroke, carotid endarterectomy, or other arterial surgery or angioplasty for atherosclerotic vascular disease in a parent, grandparent, or sibling with symptom onset or diagnosis before age 55 y for males and 65 y for females)
  • Current smoker
  • Left ventricular hypertrophy
  • Documented ankle brachial index of \<0.9
  • History of microalbuminuria, urine protein-creatinine ratio of \>2
  • CV disease (defined as one of the following):
  • Calcium score of \>0
  • +7 more criteria

You may not qualify if:

  • Unstable angina, MI, CVA, CABG \<3 months from screening visit
  • Planned coronary, cerebrovascular, or peripheral revascularization
  • Undergone major surgery within 3 months prior to screening visit or has planned major surgery during the study period
  • Uncontrolled hypertension (SBP \>190, DBP \>100 mm Hg) during screening visit
  • Uncontrolled arrhythmia \< 3 months from screening visit
  • NYHA class III-IV heart failure or if available, ejection fraction ≤ 35 %
  • Within 6 months prior to screening visit, a history of ACS or hospitalization for heart failure
  • Oral corticosteroid, prednisone (or equivalent) \> 20 mg daily
  • Anticoagulation therapy
  • Antiplatelet therapy except for aspirin
  • GI ulceration \< 60 days before screening visit
  • GI bleeding, perforation, obstruction \< 6 months of screening visit
  • Inflammatory bowel disease, diverticulitis active \< 6 months of screening visit
  • AST, ALT, or BUN \>2x the upper limit normal (within 30 days prior to screening visit)
  • Creatinine level \>1.7 mg/dL in men, 1.5 mg/dL in women (within 30 days prior to screening visit)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inova Heart and Vascular Institute

Falls Church, Virginia, 22042, United States

RECRUITING

MeSH Terms

Conditions

Arthritis, RheumatoidCardiovascular Diseases

Interventions

CelecoxibNaproxenTabletsAspirin

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNaphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDosage FormsPharmaceutical PreparationsSalicylatesHydroxybenzoatesPhenols

Study Officials

  • Kevin Bliden, BS, MBA

    Inova Health Care Services

    STUDY DIRECTOR

Central Study Contacts

Kevin Bliden, BS, MBA

CONTACT

(703) 776-7702kevin.bliden@inova.org

Emiliya Bakalska, BA

CONTACT

(410) 367-2592emiliya.bakalska@inova.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Qualified patients will be treated with immediate release 81mg aspirin for 4 weeks in the run-in period followed by randomization to celecoxib (200 mg bid) vs. naproxen sodium (550 mg bid) for 4 weeks and then cross over to the other drug for another 4 weeks. Blood and urine samples will be collected before the aspirin run-in period (baseline), 24±4 hrs after the last dose of aspirin in the run-in period, 24±4 hr after the last dose of the study drug in the first period and 24±4 hr after the last dose of the study drug in the second period. Assays for platelet function, biomarkers of inflammation and endothelial function will be performed at these time points
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2018

First Posted

October 9, 2018

Study Start

September 22, 2018

Primary Completion

September 24, 2019

Study Completion

November 24, 2019

Last Updated

October 9, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

No plan to share IPD.

Locations

US(1)