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Completed

NCT Number: NCT02070653

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

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.

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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Surgical Sciences/Vascular Surgery, Uppsala University

Uppsala, SE-751 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Ticagrelor

Drug

Placebo

Drug

Primary outcomes

  1. AAA volume growth

    Time frame: 12 months

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

Secondary outcomes

  1. AAA diameter growth, need for surgery and rupture

    Time frame: 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 outcomes

  1. Bleeding

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Acronym: TicAAA

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Feb 25, 2014
Registry last updated
May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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