Clinical trial NCT02070653: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Abdominal Aortic Aneurysm
Keywords: Aorta
Aneurysm
Antiplatelet
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2014-02-25
Enrollment: 145
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: AAA volume growth
timeFrame: 12 months
Secondary outcomes:
measure: AAA diameter growth, need for surgery and rupture
timeFrame: 12 months
Other outcomes:
measure: Bleeding
timeFrame: 12 months
Locations:
city: Uppsala
country: Sweden
facility: Department of Surgical Sciences/Vascular Surgery, Uppsala University
Study officials:
affiliation: Uppsala University, Sweden
name: Anders Wanhainen, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.