search
Back to results

Cyclosporine A in Patients With Small Diameter Abdominal Aortic Aneurysms (ACA4)

Primary Purpose

Abdominal Aortic Aneurysm,, Small Abdominal Aortic Aneurysm

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Cyclosporine A
Cyclosporine A
Placebo
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm, focused on measuring Drug therapy, Prevention and control, Healing, Tissue regeneration, Therapy

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male patients with asymptomatic AAA ≥ 30 mm, ≤ 49 mm
  • Female patients with asymptomatic AAA ≥ 25 mm, ≤ 44 mm

Exclusion Criteria:

  • Common iliac aneurysm > 25 mm
  • Saccular aneurysm of the aorta
  • Inflammatory aneurysm
  • No signature of informed consent
  • Renal dysfunction
  • Diabetes

Sites / Locations

  • Henri Mondor HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Cyclosporine A dose 1

Cyclosporine A dose 2

Placebo

Arm Description

Outcomes

Primary Outcome Measures

AAA diameter evolution on CT-scanner 12 months after treatment interruption

Secondary Outcome Measures

AAA diameter evolution on duplex-scanner 12 months after treatment interruption
Renal function (creatinine clearance)
All cause cardiovascular mortality and morbidity

Full Information

First Posted
August 6, 2014
Last Updated
June 1, 2015
Sponsor
Assistance Publique - Hôpitaux de Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT02225756
Brief Title
Cyclosporine A in Patients With Small Diameter Abdominal Aortic Aneurysms
Acronym
ACA4
Official Title
Brief Administration of Cyclosporine A to Induce the Stabilisation of the Diameter of Small Diameter Abdominal Aortic Aneurysms.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Aneurysms of the aorta are dilatations of the main artery in the body that distributes blood to organs. Aneurysms expose patients to aortic rupture. The risk of aortic rupture is high for large aneurysms, and low for small aneurysms. Currently, if the diameter of a small aneurysm grows up to a level at risk for rupture, surgery is indicated to prevent rupture. A drug that would stop growth of small aneurysms would obviate aortic surgery, the current treatment to prevent aortic rupture in patients. The ACA4 study aims at testing the possibility to stop growth of small aortic aneurysms in the abdomen with a drug, cyclosporine A. Patients with small aneurysms will receive cyclosporine A orally, or a placebo (fake liquid), every day during a short period of time. Efficacy of the drug will be evaluated by measuring the diameter of the aneurysm during 2 years after treatment cessation. Drug safety analysis will evaluate the impact of the drug on renal function, blood pressure, and other parameters. In case of adverse event during the drug administration phase, dose of the drug or of the placebo will be decreased or administration stopped.
Detailed Description
Abdominal aortic aneurysms (AAAs) expose patients to death caused by aortic rupture. Although screening of AAAs has been shown to decrease AAA-related mortality, translation into medical practice of screening is limited because there is no specific treatment to limit growth of AAAs below diameter thresholds for open surgery or stent graft. We have developed different approaches aimed at inducing healing and thereby stabilizing formed AAAs in animal models. We have identified TGF-beat1 as an inducer of experimental AAA healing. Cyclosporine A is an inducer of tumor growth factor - beta1 (TGF-beta1) in experimental AAAs and in human atherosclerotic AAAs in vitro, causing overgrowth of inflamed tissues. Since AAAs are caused by aortic wall atrophy, we have hypothesised and confirmed in animals, that cyclosporine AAA, when administrated during a short period of time, durably stabilizes small AAA diameter in animals, while inducing aortic wall reconstruction and healing. The clinical trial ACA4 is a multicentric randomized, placebo controlled, double blind trial that will enrol 360 patients with small AAAs in France. Two doses of cyclosporine A will be tested against a placebo (three arms). Drug administration will be short, and AAA diameter evaluation will be performed for 2 years, by CT-scanner (main outcome) with no contrast, and duplex-scanner.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm,, Small Abdominal Aortic Aneurysm
Keywords
Drug therapy, Prevention and control, Healing, Tissue regeneration, Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cyclosporine A dose 1
Arm Type
Experimental
Arm Title
Cyclosporine A dose 2
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cyclosporine A
Intervention Description
Oral administration for a short time of cyclosporine A dose 1
Intervention Type
Drug
Intervention Name(s)
Cyclosporine A
Intervention Description
Oral administration for a short time of cyclosporine A dose 2
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral administration for a short time of placebo
Primary Outcome Measure Information:
Title
AAA diameter evolution on CT-scanner 12 months after treatment interruption
Time Frame
1 years
Secondary Outcome Measure Information:
Title
AAA diameter evolution on duplex-scanner 12 months after treatment interruption
Time Frame
1 years
Title
Renal function (creatinine clearance)
Time Frame
at inclusion visit, V4 and V8
Title
All cause cardiovascular mortality and morbidity
Time Frame
at V1 and V8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male patients with asymptomatic AAA ≥ 30 mm, ≤ 49 mm Female patients with asymptomatic AAA ≥ 25 mm, ≤ 44 mm Exclusion Criteria: Common iliac aneurysm > 25 mm Saccular aneurysm of the aorta Inflammatory aneurysm No signature of informed consent Renal dysfunction Diabetes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Allaire, MD. PhD.
Phone
(0)1 49 81 44 20
Ext
+33
Email
eric.allaire@hmn.aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Morgane Quéré-Carne, CRA
Phone
(0)1 49 81 37 52
Ext
+33
Email
morgane.quere-carne@hmn.aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Allaire, MD. PhD.
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor Hospital
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Antoinette Sevestre, MD, PhD
Phone
(0)3 22 45 56 24
Ext
+33
Email
sevestre.marie-antoinette@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Patrick Lermusiaux, MD, PhD
Phone
(0)4 72 11 76 76
Ext
+33
Email
patrick.lermusiaux@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Eric Allaire, MD. PhD

12. IPD Sharing Statement

Learn more about this trial

Cyclosporine A in Patients With Small Diameter Abdominal Aortic Aneurysms

We'll reach out to this number within 24 hrs