Brief Title
The Efficacy of Ticagrelor on Abdominal Aortic Aneurysm (AAA) Expansion
Official Title
Does Ticagrelor Inhibit Growth of Small Abdominal Aortic Aneurysms? A Randomised Controlled Trial (TicAAA)
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
AAA volume growth
Secondary Outcome
AAA diameter growth, need for surgery and rupture
Condition
Abdominal Aortic Aneurysm
Intervention
Ticagrelor
Study Arms / Comparison Groups
Ticagrelor
Description: Ticagrelor 90 mg tablets twice daily for 12 months.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
145
Start Date
March 2014
Completion Date
July 2017
Primary Completion Date
July 2016
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- MRI exclusion criteria, such as: severe claustrophobia, pacemaker, metallic implants
in brain, cochlear implants.
- 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.
- Any condition or laboratory finding which in the opinion of the Investigator makes the
patient unsuitable for inclusion (eg, active malignancy other than squamous cell or
basal cell skin cancer, long-term concomitant treatment with non-steroidal
anti-inflammatory drugs (NSAIDs).
Gender
All
Ages
50 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Anders Wanhainen, MD. PhD, ,
Location Countries
Sweden
Location Countries
Sweden
Administrative Informations
NCT ID
NCT02070653
Organization ID
UpAAA - 2014 - 01
Responsible Party
Sponsor
Study Sponsor
Uppsala University
Collaborators
AstraZeneca
Study Sponsor
Anders Wanhainen, MD. PhD, Principal Investigator, Uppsala University, Sweden
Verification Date
May 2018