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

Primary Purpose

Abdominal Aortic Aneurysm

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Ticagrelor
Placebo
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm focused on measuring Aorta, Aneurysm, Antiplatelet

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Department of Surgical Sciences/Vascular Surgery, Uppsala University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ticagrelor

Placebo

Arm Description

Ticagrelor 90 mg tablets twice daily for 12 months.

Ticagrelor-placebo tablets twice daily for 12 months.

Outcomes

Primary Outcome Measures

AAA volume growth
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
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

Full Information

First Posted
February 21, 2014
Last Updated
May 1, 2018
Sponsor
Uppsala University
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT02070653
Brief Title
The Efficacy of Ticagrelor on Abdominal Aortic Aneurysm (AAA) Expansion
Acronym
TicAAA
Official Title
Does Ticagrelor Inhibit Growth of Small Abdominal Aortic Aneurysms? A Randomised Controlled Trial (TicAAA)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
Keywords
Aorta, Aneurysm, Antiplatelet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor
Arm Type
Active Comparator
Arm Description
Ticagrelor 90 mg tablets twice daily for 12 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Ticagrelor-placebo tablets twice daily for 12 months.
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
AAA volume growth
Description
To determine mean reduction in AAA volume growth rate (%) measured with magnetic resonance imaging (MRI) at 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
AAA diameter growth, need for surgery and rupture
Description
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
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Bleeding
Description
To determine bleeding events; primary according to BARC (Bleeding Academic Research Consortium) and secondary according to TIMI (Thrombolysis in Myocardial Infarction) Major and Minor.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Wanhainen, MD. PhD
Organizational Affiliation
Uppsala University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgical Sciences/Vascular Surgery, Uppsala University
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
31135888
Citation
Wanhainen A, Mani K, Kullberg J, Svensjo S, Bersztel A, Karlsson L, Holst J, Gottsater A, Linne A, Gillgren P, Langenskiold M, Hultgren R, Roy J, Gilgen NP, Ahlstrom H, Lederle FA, Bjorck M. The effect of ticagrelor on growth of small abdominal aortic aneurysms-a randomized controlled trial. Cardiovasc Res. 2020 Feb 1;116(2):450-456. doi: 10.1093/cvr/cvz133.
Results Reference
derived

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

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