The Efficacy of Ticagrelor on Abdominal Aortic Aneurysm (AAA) Expansion

Does Ticagrelor Inhibit Growth of Small Abdominal Aortic Aneurysms? A Randomised Controlled Trial (TicAAA)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02070653

Acronym

TicAAA

Enrollment

145

Registered

2014-02-25

Start date

2014-03-31

Completion date

2017-07-31

Last updated

2018-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysm

Keywords

Aorta, Aneurysm, Antiplatelet

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.

Interventions

DRUGTicagrelor

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
AAA diameter growth, need for surgery and rupture	12 months	To determine mean reduction in diameter growth rate (mm), measured with MRI and ultra sound (US), mean reduction in thrombus volume enlargement rate (%) measured with MRI, need for surgery (≥55mm), aneurysm rupture, at 12 months

Other

Measure	Time frame	Description
Bleeding	12 months	To determine bleeding events; primary according to BARC (Bleeding Academic Research Consortium) and secondary according to TIMI (Thrombolysis in Myocardial Infarction) Major and Minor.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026