Franciscus Rheumatoid Arhtritis and Cardiovascular Intervention Study

Franciscus Rheumatoid Arhtritis and Cardiovascular Intervention Study - FRANCIS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34401

Enrollment

316

Registered

2010-10-20

Start date

2011-02-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

Interventions

Patients with a cardiovascular risk 6.4%. When Hba1c is above 7.0% sitagliptine is added. When HbA1c stays above 7.0% treatment may be altered as seen fit. To minimize the burden for patients parti

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Rheumatoid arhrtitis for at least 5 years 40-70 years old

Exclusion criteria

Exclusion criteria: Diabetes mellitus a prior cardiovascular event

Design outcomes

Primary

Measure	Time frame
Primary outcome measure is the progression of the carotid artery intima media thickness (IMT) at 5 years follow-up.	—

Secondary

Measure	Time frame
Secondary outcome measures are the following: 1) cardiovascular mortality 2) cardiovascular events, i.e. nonfatal stroke, nonfatal myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention, revascularisation for peripheral atherosclerotic arterial disease, amputation because of ischaemia.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)