Does Ticagrelor inhibit growth of small abdominal aortic aneurysms? A randomised controlled trial (TicAAA)

Phase 1

• Conditions: Small abdominal aortic aneurysm; MedDRA version: 14.1Level: LLTClassification code 10000051Term: Abdominal aneurysmSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-002736-24-SE
• Lead Sponsor: ppsala University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-14
• Last Update Posted: 13 November 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1.Provision of written informed consent
2.Male and female subjects
3.Age 50-85 years
4.Documented infrarenal aortic aneurysm between 35-49 mm
5. ASA-naïve (defined as not on regular ASA-treatment within the last 3 months prior to visit 1)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

Patients should not enter the study if any of the following exclusion criteria are fulfilled:
1.Short expected survival.
2.On anti-platelet therapy.
3.On long-term oral or parenteral anticoagulant treatment.
4.On strong inhibitors of CYP3A enzyme (Ketoconazole, Itraconazole, Vorikonazole, Telithromycin, Clarithomycin, Ritonavir, Saquinavir, Nelfinavir, Indinavir, Atazanavir).
5.On CYP3A substrates or inducers >40mg daily doses (Simvastatin, Lovastatin, Rifampin/rifampicin, Phenytoin, Carbamazepine, Phenobarbital).
6.Known or suspected connective tissue disorder (Marfans syndrome, etc), infected or inflammatory aneurysm, aneurysm post aortic dissection or previous surgery of the infrarenal aorta.
7.Increased risk for bradycardia or ongoing treatment with any bradycardia inducing drug.
8.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.
9.Known haemostatic or coagulation disorder, gastrointestinal bleeding within the past 6 months, or increased bleeding risk due to surgery or trauma within 30 days.
10.MRI exclusion criteria, such as: severe claustrophobia, pacemaker, metallic implants in brain, cochlear implants.
11.Metallic implants in aortic region.
12.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.
13.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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the efficacy of Ticagrelor on AAA-expansion in a multi-centre, randomized, double-blinded for Ticagrelor and placebo.;Primary end point(s): Mean reduction in AAA volume growth rate (%) measured with magnetic resonance imaging (MRI) at 12 months ;Timepoint(s) of evaluation of this end point: 12 months;Secondary Objective: 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 <br><br>To determine bleeding events; primary according to BARC (Bleeding Academic Research Consortium) and secondary according to TIMI (Thrombolysis in Myocardial Infarction) Major and Minor.

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 12 months;Secondary end point(s): 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