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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Abdominal Aortic Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ticagrelor

Ticagrelor 90 mg tablets twice daily for 12 months.

Group Type ACTIVE_COMPARATOR

Ticagrelor

Intervention Type DRUG

Placebo

Ticagrelor-placebo tablets twice daily for 12 months.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Ticagrelor

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
* 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).

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No