Abdominal Aortic AneurysmPhase 2TicAAANCT02070653
The Efficacy of Ticagrelor on Abdominal Aortic Aneurysm (AAA) Expansion
A Phase 2 study testing Ticagrelor in people with Abdominal Aortic Aneurysm, run by Uppsala University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Ticagrelor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2014to Jul 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Surgical Sciences/Vascular Surgery, Uppsala University
Uppsala, SE-751 85
About this study
Official title: Does Ticagrelor Inhibit Growth of Small Abdominal Aortic Aneurysms? A Randomised Controlled Trial (TicAAA)
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.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Ticagrelor, Placebo
- Keywords
- Aorta, Aneurysm, Antiplatelet
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Active comparator | Ticagrelor 90 mg tablets twice daily for 12 months. Receives: Drug: Ticagrelor |
| Placebo | Placebo comparator | Ticagrelor-placebo tablets twice daily for 12 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AAA volume growth
To determine mean reduction in AAA volume growth rate (%) measured with magnetic resonance imaging (MRI) at 12 months
Measured: 12 months
Secondary outcomes (1)
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Anders Wanhainen, MD. PhD, Principal investigator, Uppsala University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070653
- Sponsor's protocol ID
- UpAAA - 2014 - 01
- Acronym
- TicAAA
- Status last verified
- May 2018
- First submitted
- 21 Feb 2014
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31135888
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Ticagrelor Inhibit Growth of Small Abdominal Aortic Aneurysms? A Randomised Controlled Trial (TicAAA)
- ClinicalTrials.gov ID
- NCT02070653
- Acronym / sponsor ID
- TicAAA / UpAAA - 2014 - 01
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Aorta, Aneurysm, Antiplatelet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Mar 2014 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 25 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Active comparator | Drug: TicagrelorTicagrelor 90 mg tablets twice daily for 12 months. |
| Placebo | Placebo comparator | Drug: PlaceboTicagrelor-placebo tablets twice daily for 12 months. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ticagrelor | Drug | Ticagrelor |
| Placebo | Drug | Placebo |
Primary outcome
AAA volume growth
Time frame: 12 months
To determine mean reduction in AAA volume growth rate (%) measured with magnetic resonance imaging (MRI) at 12 months
1 secondary outcome
AAA diameter growth, need for surgery and rupture
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Derived from this study: PubMed 31135888Wanhainen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Wanhainen, MD. PhD principal investigator
Uppsala University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ticagrelor in people with Abdominal Aortic Aneurysm, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AAA volume growth (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02070653, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.