NCT02225756

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2013

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

June 3, 2015

Status Verified

May 1, 2015

Enrollment Period

3.8 years

First QC Date

August 6, 2014

Last Update Submit

June 1, 2015

Conditions

Abdominal Aortic Aneurysm,Small Abdominal Aortic Aneurysm

Keywords

Drug therapyPrevention and controlHealingTissue regenerationTherapy

Outcome Measures

Primary Outcomes (1)

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

    1 years

Secondary Outcomes (3)

  • AAA diameter evolution on duplex-scanner 12 months after treatment interruption

    1 years

  • Renal function (creatinine clearance)

    at inclusion visit, V4 and V8

  • All cause cardiovascular mortality and morbidity

    at V1 and V8

Study Arms (3)

Cyclosporine A dose 1

EXPERIMENTAL
Drug: Cyclosporine A

Cyclosporine A dose 2

EXPERIMENTAL
Drug: Cyclosporine A

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Cyclosporine ADRUG

Oral administration for a short time of cyclosporine A dose 1

Cyclosporine A dose 1
PlaceboDRUG

Oral administration for a short time of placebo

Placebo

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Eric Allaire, MD. PhD.

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Allaire, MD. PhD.

CONTACT

(0)1 49 81 44 20eric.allaire@hmn.aphp.fr

Morgane Quéré-Carne, CRA

CONTACT

(0)1 49 81 37 52morgane.quere-carne@hmn.aphp.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2014

First Posted

August 26, 2014

Study Start

December 1, 2013

Primary Completion

September 1, 2017

Study Completion

September 1, 2018

Last Updated

June 3, 2015

Record last verified: 2015-05

Locations

FR(1)