NCT02070653

Brief Summary

Abdominal aortic aneurysm (AAA) is a major health problem and ruptured AAA is a common cause of death in Europe and North America. A key limitation of contemporary treatment strategies of AAA is the lack of therapy directed at reducing expansion. Although surgical repair is an effective treatment for large AAA, it is associated with significant mortality and morbidity as well as substantial cost. The rationale for this randomized controlled study is to investigate whether treatment with Ticagrelor inhibits growth of small abdominal aortic aneurysms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

2.3 years

First QC Date

February 21, 2014

Last Update Submit

May 1, 2018

Conditions

Abdominal Aortic Aneurysm

Keywords

AortaAneurysmAntiplatelet

Outcome Measures

Primary Outcomes (1)

  • AAA volume growth

    To determine mean reduction in AAA volume growth rate (%) measured with magnetic resonance imaging (MRI) at 12 months

    12 months

Secondary Outcomes (1)

  • AAA diameter growth, need for surgery and rupture

    12 months

Other Outcomes (1)

  • Bleeding

    12 months

Study Arms (2)

Ticagrelor

ACTIVE COMPARATOR

Ticagrelor 90 mg tablets twice daily for 12 months.

Drug: Ticagrelor

Placebo

PLACEBO COMPARATOR

Ticagrelor-placebo tablets twice daily for 12 months.

Drug: Placebo

Interventions

TicagrelorDRUG
Ticagrelor
PlaceboDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

  • Provision of written informed consent
  • Male and female patients
  • Age 50-85 years
  • Documented infrarenal aortic aneurysm between 35-49 mm
  • Acetylsalicylic acid (ASA)-naïve

You may not qualify if:

  • Short expected survival.
  • On anti-platelet therapy.
  • On long-term oral or parenteral anticoagulant treatment.
  • On strong inhibitors of CYP3A enzyme (Ketoconazole, Itraconazole, Voriconazole, Telithromycin, Clarithromycin, Ritonavir, Saquinavir, Nelfinavir, Indinavir, Atazanavir).
  • On CYP3A (Cytochrome P450, family 3, subfamily A) substrates or inducers \>40mg daily doses (Simvastatin, Lovastatin, Rifampin/rifampicin, Phenytoin, Carbamazepine, Phenobarbital).
  • Known or suspected connective tissue disorder (Marfans syndrome, etc), infected or inflammatory aneurysm, aneurysm post aortic dissection or previous surgery of the infrarenal aorta.
  • Increased risk for bradycardia or ongoing treatment with any bradycardia inducing drug.
  • Contraindication for Ticagrelor; hypersensitivity to Ticagrelor or any of the excipients, active pathological bleeding, history of intracranial hemorrhage, moderate or severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy), on haemodialysis.
  • Known haemostatic or coagulation disorder, gastrointestinal bleeding within the past 6 months, or increased bleeding risk due to surgery or trauma within 30 days.
  • Metallic implants in aortic region.
  • Enrolled in either another investigational drug or medical device study or another investigational study of an approved drug or medical device within 30 days prior to visit 1 of the current study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgical Sciences/Vascular Surgery, Uppsala University

Uppsala, SE-751 85, Sweden

Location

Related Publications (1)

  • Wanhainen A, Mani K, Kullberg J, Svensjo S, Bersztel A, Karlsson L, Holst J, Gottsater A, Linne A, Gillgren P, Langenskiold M, Hultgren R, Roy J, Gilgen NP, Ahlstrom H, Lederle FA, Bjorck M. The effect of ticagrelor on growth of small abdominal aortic aneurysms-a randomized controlled trial. Cardiovasc Res. 2020 Feb 1;116(2):450-456. doi: 10.1093/cvr/cvz133.

    PMID: 31135888DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalAneurysm

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Aortic AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Anders Wanhainen, MD. PhD

    Uppsala University, Sweden

    PRINCIPAL INVESTIGATOR

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

February 21, 2014

First Posted

February 25, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2017

Last Updated

May 2, 2018

Record last verified: 2018-05

Locations

SE(1)