Evaluation of administration of gevokizumab versus placebo on the reduction of atheroma plaque inflammation.

Active, not recruiting

• Conditions: MedDRA version: 16.0Level: LLTClassification code 10011093Term: Coronary atherosclerosisSystem Organ Class: 100000004849; Arterial wall inflammation in patients with marked atherosclerotic plaque inflammation; MedDRA version: 16.0Level: LLTClassification code 10057703Term: Coronary atherosclerosis of non-autologous biological bypass graftSystem Organ Class: 100000004849; MedDRA version: 16.0Level: LLTClassification code 10058152Term: Coronary atherosclerosis of bypass graftSystem Organ Class: 100000004849; MedDRA version: 16.0Level: LLTClassification code 10018104Term: Generalized and unspecified atherosclerosisSystem Organ Class: 100000004866; MedDRA version: 16.0Level: LLTClassification code 10002892Term: Aortic atherosclerosisSystem Organ Class: 100000004866; MedDRA version: 16.0Level: LLTClassification code 10003603Term: Atherosclerosis generalizedSystem Organ Class: 100000004866; MedDRA version: 16.0Level: LLTClassification code 10003605Term: Atherosclerosis of aortaSystem Organ Class: 100000004866; MedDRA version: 16.0Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 100000004866; MedDRA version: 16.0Level: LLTClassification code 10011076Term: Coronary artery atherosclerosisSystem Organ Class: 100000004849

• Registration Number: EUCTR2012-002677-53-FI
• Lead Sponsor: Institut de Recherches Internationales Servier (I.R.I.S.)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-20
• Last Update Posted: 2015-01-06

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

- A mean maximum TBR (target to background ratio) > 1.8 centrally measured in any region of interest.
- No change in use of statin and other antidyslipidemic treatments since selection visit
- 50 years of age or older
- A documented recent (3-12 months, inclusive) acute coronary syndrome (ACS)
- Completion of all revascularisation procedures, 3 months before at least
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 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

- Positive HIV, Hepatitis C antibody and Hepatitis B antigen.
- Evidences of TB infection
- Type 1 diabetes and uncontrolled type 2 diabète
- Urinary incontinence
- Corrected QT interval duration (Bazett’s formula) > 450 ms for a male and 470 ms for a female measured at selection visit or Family history of long QT syndrome or congenital long QT syndrome.
- Chronic inflammatory disease
- History of malignancy within 3 years prior to Selection
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- Infectious disease
- History or symptoms of a demyelinating disease
- History of coronary artery bypass graft
- Hemodynamic instability including hypotension, marked congestive heart failure.
- Severe or uncontrolled hypertension, or systolic blood pressure < 90 mmHg at selection.
- Introduction or modification of any anti-dyslipidemic drug treatment other than statin in
the two months prior to Selection
- Patient with any internal device or prosthesis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified