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

Abdominal Aortic Aneurysm Clinical Trial

— TicAAA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02070653
• Other study ID #: UpAAA - 2014 - 01
• Status: Completed
• Phase: Phase 2
• Start date: March 2014
• Est. completion date: July 2017

Study information

• Verified date: May 2018
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: July 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Drug:
• Ticagrelor

• Placebo

Locations

Country	Name	City	State
Sweden	Department of Surgical Sciences/Vascular Surgery, Uppsala University	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bleeding	To determine bleeding events; primary according to BARC (Bleeding Academic Research Consortium) and secondary according to TIMI (Thrombolysis in Myocardial Infarction) Major and Minor.	12 months
Primary	AAA volume growth	To determine mean reduction in AAA volume growth rate (%) measured with magnetic resonance imaging (MRI) at 12 months	12 months
Secondary	AAA diameter growth, need for surgery and rupture	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	12 months