An Observational Study of Burden of Upper GI-Symptoms in CV Risk Patients

AstraZeneca1,836 enrolled

Overview

The purpose of this study is to investigate the burden of upper gastrointestinal symptoms in patients with cardiovascular disease taking low dose aspirin

Study Type

OBSERVATIONAL

Enrollment

1,836

Conditions

Cardiovascular Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Provision of signed written inform consent. * Physician prescribed or recommended daily intake of Low Dose Aspirin (LDA) (75-325 mg daily) for cardiovascular disease prevention within the past 12 months. * Established cardiovascular disease, such as CAD (CoronaryArtery Disease), previous TIA (Transient Ischemic Attack), ischemic stroke or subjects with known risk factors for cardiovascular disease without having experienced cardiovascular events Exclusion Criteria: * Need for concomitant treatment with a non-ASA NSAID (Nonsteroidal Antiinflammatory Drugs) including acyclooxygenase-2 (COX-2) selective NSAID. Occasional use of up to 1 day/week is allowed.

Locations (3)

Research Site

Brentwood, Tennessee, United States

Research Site

Saint-Laurent, Quebec, Canada

Research Site

Paris, France

Outcomes

Primary Outcomes

Cross-sectional survey, SitePro Survey Domains including; background, UGI screening, PPI and H2 blocker usage, interaction between UGI and LDA ,UGI symptoms, HADS, Morisky Medication Taking Behavior Scale, SF12, SSA-P

Time frame: Once at enrollment

Secondary Outcomes

EMA assessments including: Sleep, Mood, Activities, Eating/food,GI symptoms,GI coping strategies, Medication usage, Healthcare Utilization

Time frame: Four times daily for three months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.