A RANDOMISED, DOUBLE-BLIND, MULTINATIONAL STUDY TO PREVENT MAJOR VASCULAR EVENTS WITH TICAGRELOR COMPARED TO ASPIRIN (ASA) IN PATIENTS WITH ACUTE ISCHAEMIC STROKE OR TIA[SOCRATES –ACUTE STROKE OR TRANSIENT ISCHAEMIC ATTACK TREATED WITH ASPIRIN OR TICAGRELOR AND PATIENT OUTCOMES]
- Conditions
- -I63I63
- Registration Number
- PER-081-13
- Lead Sponsor
- ASTRAZENECA PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 135
1. Provision of informed consent prior to any study specific procedures
2. Men or women ≥40 years of age
3. Either acute ischaemic stroke or high-risk TIA as defined here and randomisation
occurring within 24 hours after onset of symptoms:
Acute ischaemic stroke, defined as:
• Neurological deficit attributed to the focal brain ischaemia, and either of the
following:
− Persistent signs or symptoms of the ischaemic event at the time of
randomisation,
OR
− Acute, ischaemic brain lesion documented by computed tomography scan
or magnetic resonance imaging (diffusion-weighted imaging) within 24
hours of onset of symptoms
• National Institute of Health Stroke Score ≤5
High-risk TIA, defined as:
• Neurological deficit of acute onset attributed to focal ischaemia of the brain by
history or examination with complete resolution of the deficit, and at least one of
the following:
− ABCD2 score ≥4 and TIA symptoms not limited to isolated numbness,
isolated visual changes, or isolated dizziness/vertigo
− Symptomatic intracranial arterial occlusive disease documented by
transcranial doppler, ultrasound or vascular imaging, defined as at least
50% narrowing in diameter of a vessel that could account for the clinical
presentation
− Documented internal carotid arterial occlusive disease, defined as at least
50% narrowing in diameter of a vessel that could account for the clinical
presentation
4. Head Computed Tomography (CT) or MRI ruling out haemorrhage or other
pathology, such as vascular malformation, tumour, or abscess that could explain
symptoms or contraindicate therapy
1. Planned use of antithrombotic therapy in addition to study medication including
antiplatelets (eg, open label ASA, GPIIb/IIIa inhibitors, clopidogrel, ticlopidine,
prasugrel, dipyridamole, ozagrel, cilostazol) and anticoagulants (eg, warfarin, oral
thrombin and factor Xa inhibitors, bivalirudin, hirudin, argatroban, unfractionated
and low molecular weight heparins). In addition, patients receiving or requiring
dual antiplatelet therapy with ASA and P2Y12 inhibitors will be excluded.
2. Known hypersensitivity to ticagrelor or ASA
3. Any history of atrial fibrillation, ventricular aneurysm or suspicion of
cardioembolic pathology for TIA or stroke
4. Planned carotid, cerebrovascular, or coronary revascularisation that requires halting
study medication within 7 days of randomisation
5. Receipt of any intravenous or intra-arterial thrombolysis or mechanical
thrombectomy within 24 hours prior to randomisation
6. Anticipated concomitant oral or intravenous therapy with strong cytochrome P450
3A (CYP3A) inhibitors or CYP3A substrates with narrow therapeutic indices that
cannot be stopped for the course of the study
− Strong inhibitors: ketoconazole, itraconazole, voriconazole,
telithromycin, clarithromycin (but not erythromycin or azithromycin),
nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir
− CYP3A substrates with narrow therapeutic index: cyclosporine,
quinidine, simvastatin at doses >40 mg daily or lovastatin at doses
>40 mg daily
7. Anticipated requirement for long-term (>7 days) non-steroidal anti-inflammatory
drugs (NSAIDs)
8. Patients with known bleeding diathesis or coagulation disorder (eg, thrombotic
thrombocytopenic purpura)
9. History of previous symptomatic non-traumatic intracerebral bleed at any time
(asymptomatic microbleeds do not qualify), gastrointestinal (GI) bleed within the
past 6 months, or major surgery within 30 days
10. Known severe liver disease (eg, ascites or signs of coagulopathy)
11. Renal failure requiring dialysis
12. Pregnancy or lactation
13. Involvement in the planning and/or conduct of the study (applies to both
AstraZeneca staff and/or staff at the study site)
14. Inability of the patient to understand and/or comply with study procedures and/or
follow-up, in the opinion of the Investigator
15. Previous enrolment or randomisation in the present study
16. Participation in another clinical study with an investigational product during the last
30 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method