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

Sponsor

Uppsala University (Other)

Overall Status

Completed

CT.gov ID

NCT02070653

Collaborator

AstraZeneca (Industry)

145

Enrollment

Location

Arms

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysm	Drug: Ticagrelor Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

145 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ticagrelor Ticagrelor 90 mg tablets twice daily for 12 months.	Drug: Ticagrelor
Placebo Comparator: Placebo Ticagrelor-placebo tablets twice daily for 12 months.	Drug: Placebo

Arm

Intervention/Treatment

Active Comparator: Ticagrelor

Ticagrelor 90 mg tablets twice daily for 12 months.

Drug: Ticagrelor

Placebo Comparator: Placebo

Ticagrelor-placebo tablets twice daily for 12 months.

Drug: Placebo

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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 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).