Cardiovascular risk in patients with Ankylosing Spondylitis

• Register: EUCTR
• Last refreshed on: 27 January 2014
• Main ID: EUCTR2013-002860-19-NL
• Date of registration: 15/08/2013
• Prospective Registration: Yes
• Primary sponsor: AMC
• Public title: Cardiovascular risk in patients with Ankylosing Spondylitis
• Scientific title: The risk of cardiovascular disease in Ankylosing Spondylitis; A Single Center Cross-Sectional Study Evaluating The Association Between Inflammation In Ankylosing Spondylitis And Vascular Inflammation - AS risk
• Date of first enrolment: 07/01/2014
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002860-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Netherlands

Contacts

• Name: Erik Stroes
• Affiliation: AMC

• Name: Erik Stroes
• Affiliation: AMC

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects with AS
? Age: =18 years
? Diagnosis of AS (following the 1984 Modified New York Criteria for ankylosing Spondylitis (16)) + disease duration since start of first symptoms for a period of more than 3 years.
? Subject agrees to the restrictions as described in paragraph 4.4.2. In brief: subjects are not permitted any alcohol or caffeine-containing food or drinks from 12 hrs prior to study visits until discharge. In addition, no strenuous exercise is permitted for 24 hrs before the study visits

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects may not enter this study if they meet the following criteria
? BMI > 30.
? History of diabetes mellitus/insulin use
? Hypertension/use of blood pressure lowering medication
? Smoking
? Use of statins prior to inclusion, or contra-indications for statin use.
? History of cardiovascular events
? Proven or suspected bacterial infections. Recent (<1 month prior to screening) or ongoing
? Serious infection requiring IV antibiotic therapy.
? Recent or current treatment with medications that may have a significant effect on plaque Inflammation as measured by plaque TBR, including but not limited to: Biological based medicines (anti-TNF (ex. Infliximab), anti-IL-6 therapy (ex. Tocilizumab) or anti-IL-1 (ex. anakinra)) within 8 weeks before the baseline visit and during the study.
? Any clinically significant medical condition that could interfere with the conduct of the study.
? Standard contra-indications to MRI, 18FDG PET, and CT, including pregnancy and lactating women.
? Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
? Subject has planned cardiac surgery, PCI or carotid stenting, or major non-cardiac surgery during the course of the study period or for 14 days after the last treatment.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Ankylosing Spondylitis Atherosclerotic cardiovascular disease

Intervention(s)

Trade Name: Atorvastatin
Product Name: Atorvastatin
Product Code: 5057732
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ATORVASTATIN
CAS Number: 134523-00-5
Other descriptive name: atorvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

Secondary Objective: ? To evaluate the change in vessel wall inflammation in AS over a follow up period of 3 years by means of FDG PET/CT.
? To determine the association between the systemic inflammation caused by AS and aorta and carotid wall inflammation in patients with AS, at baseline, after statin therapy intervention and at follow up period of three years.

Timepoint(s) of evaluation of this end point: At baseline, after 3 months of statin therapy and 1-2 years follow-up

Main Objective: To evaluate the anti-inflammatory effects of statin therapy on vessel wall inflammation by means of FDG PET/CT in AS patients

Primary end point(s): Main study parameter/endpoint
- change in Target-to-background ratio (TBR) in AS patients before and after statin therapy

Secondary Outcome(s)

Secondary end point(s): Secondary study parameters/endpoints
? AS disease duration
? Medical history, medication use, prior use of DMARD’s and biologicals
? Demographic parameters (age, race, gender)
? Blood pressure, heart rate, body weight
? Inflammatory parameters: CRP, hsCRP, BSE, IL1, Il6, TNF, IL17
? Parameters of cardiovascular risk: Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, LP(a), blood pressure, and a spite tube for extra analyses.
? Changes in cellular inflammatory processes in whole blood by buffycoat isolation.
? Pre-existing (concurrent) conditions (those present at the screening visit)
? Vital signs (supine) and body temperature

Timepoint(s) of evaluation of this end point: At baseline, after 3 months of statin therapy and 1-2 years follow-up

Secondary ID(s)

2012

Source(s) of Monetary Support

AMC