To investigate if antiplatelet therapy consisting of ticagrelor plus ASA is superior to clopidogrel plus ASA in preventing ischaemic brain lesions occurring as a result of CAS assessed on magnetic resonance imaging (MRI).
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy outcome is the presence of at least one new ischaemic
brain lesion on the second MRI scan done 1-3 days after CAS or on the third MRI
scan done 28-32 days after CAS, which had not been present on the first MRI
scan done 1-3 days before CAS.
Secondary outcome
Secondary efficacy outcomes are: (1) the total number of new ischaemic brain
lesions on MRI after CAS; and (2) the total volume of new ischaemic brain
lesions on MRI after CAS, defined as the sum of all volumes of separate DWI
lesions.
Background summary
Carotid artery stenting (CAS) is an emerging treatment for atherosclerotic
carotid stenosis. The main adverse event is embolic stroke during the
procedure. Current medical management to prevent peri-procedural embolisation
consists of dual antiplatelet therapy with clopidogrel and ASA. Ticagrelor, a
novel reversible inhibitor of the platelet adenosine diphosphate receptor
P2Y12, was superior to clopidogrel, as add-on therapy to ASA, in preventing
stent thrombosis, cardiovascular outcome events, and death in patients
undergoing coronary artery stenting, without causing an increase in major
bleeding events. The hypothesis of the present study is that ticagrelor is
superior to clopidogrel as add-on to ASA in preventing cerebral embolism during
the CAS procedure.
Study objective
To investigate if antiplatelet therapy consisting of ticagrelor plus ASA is
superior to clopidogrel plus ASA in preventing ischaemic brain lesions
occurring as a result of CAS assessed on magnetic resonance imaging (MRI).
Study design
Randomised, active-control, open, parallel-group, international, multicentre
phase II trial with blinded outcome assessment on MRI.
Intervention
Intervention: Ticagrelor 90 mg tablets will be used. Participants will receive
a loading dose of 180 mg followed by a maintenance dose of 90 mg twice daily.
Control intervention: Clopidogrel 75 mg tablets will be used. Participants will
receive a loading dose of 300 mg followed by a maintenance dose of 75 mg once
daily.
Study burden and risks
This trial compares two current medications. De change of unknown side effects
is very low. Given the expected superior effect of ticagrelor and the low risk
of side effects, we believe that the benefits of treatment with ticagrelor
outweighted the potential risks.
Patients will have a MRI scan 1-3 days before carotid artery stenting (CAS),
1-3 days after CAS and 28-32 days after CAS.
Petersgraben 4
Basel CH-4031
NL
Petersgraben 4
Basel CH-4031
NL
Listed location countries
Age
Inclusion criteria
Patients with symptomatic or asymptomatic atherosclerotic carotid stenosis
(*50% narrowing of the lumen) in whom revascularisation of the stenosis by CAS
is planned routinely are eligible to participate in the study.
Exclusion criteria
Contraindication against use of ASA (acetylsalicylic acid), clopidogrel, or
ticagrelor; anticoagulation; thrombolysis within the previous 24 hours; unable
to walk unassisted (modified Rankin Scale >3); clinically unstable; acute
coronary syndrome; need for any cardio-vascular surgery or intervention, or
need for any other invasive procedure requiring halting of Study Medication
during the Study, other than the index CAS procedure for which the patient was
randomised; bradycardia; dyspnoea; contraindications against MRI
(claustrophobia, metal implants, cardiac pacemaker); or participation in
another intervention trial. No so-ccalled vulnerable patients will be included.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-005555-27-NL |
| ClinicalTrials.gov | NCT02677545 |
| CCMO | NL58931.041.17 |