Status:
UNKNOWN
Why Does Aspirin Fail in Secondary Cerebrovascular Prevention? A Multicenter Prospective Case - Control Study
Lead Sponsor:
Fadoi Foundation, Italy
Conditions:
Cerebrovascular Disease
Eligibility:
All Genders
18+ years
Brief Summary
Multicenter prospective observational case-control study aimed at characterizing the possible determinants of treatment failure in patients with cerebrovascular disease on secondary prevention with AS...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Swallow-test positive
- Patients hospitalized for a first event of athero-thrombotic stroke (CONTROL group)
- Patients hospitalized for a recurrence of athero-thrombotic stroke on ASA therapy (CASE group)
- Informed Consent
Exclusion
- Transient ischemic attack (TIA)
- Chronic treatment with non-steroidal anti-inflammatory drugs (if occasional, not within 4 days prior to hospitalization)
- Current treatment with oral or parental anticoagulants at prophylactic or therapeutic doses
- Current treatment with other antiplatelet agents
- Thrombolysis and thrombectomy
- Cardio-embolic stroke CENTRO STUDI FONDAZIONE FADOI Page 10 Studio FADOI.01.2018 Versione n. 2 del 26/09/2019
- Carotid stenosis \>70%, with indication for revascularization
- Current treatment with ASA (only for patients in the CONTROL group)
- Acute hepatitis, chronic active hepatitis, liver cirrhosis - or alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher than the upper limit of the normal range
- Thrombocytopenia (\<150000 platelets/μl)
- Renal failure (eGFR \<30 ml/min)
- Active cancer or disease in complete remission \<1 year, except squamous cell carcinoma and basal-cell carcinoma of the skin at initial stage
- Severe chronic obstructive pulmonary disease (COPD) (oxygen therapy)
- Uncontrolled hypertension (systolic BP \>180 mmHg or diastolic BP \>100 mmHg despite antihypertensive treatment)
- Chronic inflammatory bowel disease
- Chronic treatment with corticosteroid drugs (for example Prednisone \>5 mg/die or equivalent)
- Pregnancy (in case of child-bearing potential inclusion will be possible in case of negative pregnancy test)
Key Trial Info
Start Date :
November 7 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05247931
Start Date
November 7 2019
End Date
April 30 2022
Last Update
February 21 2022
Active Locations (16)
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1
Ospedale di Assisi
Assisi, Italy
2
Ospedale Maggiore di Bologna
Bologna, Italy
3
Ospedale "S. Cuore di Gesù" Gallipoli
Gallipoli, Italy
4
Ospedale Vito Fazzi
Lecce, Italy